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Bellew v. Ethicon Prolift Case Settles After a Four-Day Trial

Judge Joseph Goodwin

Judge Joseph Goodwin

Mesh News Desk has learned that the defective pelvic mesh trial of Dianne Bellew v. Ethicon settled Friday morning at 11:30 in its fourth day of a trial being held in federal court in Charleston, West Virginia.

Six weeks ago in a Camden, Missouri courtroom, Ethicon, a Johnson & Johnson subsidiary, settled another mesh trial over the same Prolift Pelvic Floor System. A settlement avoids a defective design jury conclusion. Terms of a settlement are not revealed and the company admits no liability.

But one day before the Bellew decision, a Bakersfield, California jury found the Ethicon TVT-Abbrevo to be defectively designed, along with its instructions to doctors.

Ms. Bellew, from Tucson, Arizona, was implanted with a Prolift Pelvic Support System in July 2009 in Northwest Medical Center in Tucson, Arizona. The implanting surgeon was Carol Dehasse, MD.

Ms. Bellew’s case was transferred into federal multidistrict litigation where there are currently 24,388 filed product litigation cases filed that name Ethicon and its family of pelvic meshes. Prolift was quietly removed from the market in June 2012. The TVT-Abbrevo remains on the market.

The Bellew v. Ethicon trial was rescheduled from December 2014 to March 2, 2015 after Ethicon argued before Judge Goodwin that recent publicity about defense losses would taint the jury.

Christy Jones, from Linda Gross trial Feb 2013

Christy Jones, from Linda Gross trial Feb 2013

Attorneys Ben Anderson and Adam Slater represented Ms. Bellew. Christy Jones from Butler Snow represented Ethicon.

Ms. and Mr Perry

Ms. and Mr Perry

The California state court case of Coleen Perry v. Ethicon concluded March 5 with a jury award of $5.7 million to Ms. Perry. The jury also decided the TVT-Abbrevo, also made by Ethicon, was defectively designed and the instructions to the physician were defective or insufficient. 

The case against another mesh makers, C.R. Bard, settled last month in the same Charleston, WV courtroom, (Wise v. C.R. Bard over its Avaulta mesh) where more than 70,000 pelvic mesh cases have been consolidated against seven mesh manufacturers.

Thousands more product liability cases against pelvic mesh are filed in state courtrooms around the U.S.

Besides Bard and Ethicon, Boston Scientific, American Medical Systems, Caldera, Cook and Neomedic all face similar product liability actions. In July 2011, the U.S. Food and Drug Administration (FDA) determined complications from pelvic mesh are “not rare”  after the agency began receiving thousands of complaints from women across the country. Similar complaints are being heard from women in other countries where pelvic mesh is sold.

In the U.S. pelvic mesh used to treat incontinence is still referred to as the “gold standard” but increasingly, the implanting physician is being named  in a medical malpractice claim along with the suit naming the manufacturer.

Last month, the federal judge presiding over the multidistrict litigation, Judge Joseph Goodwin, warned both sides in this pelvic mesh litigation to set aside their differences and begin settling these cases or try them in waves or with multiple plaintiffs. #

case concluded on day five according to court calendar

108 Comments

  1. Debra says:

    Wow hopefully this is going towards something bigger to come like a global settlement hope they see that they can’t carry on and on and they are deciding to settle and that we are all truly suffering sad thing is monetary value isn’t everything they will carry on as nothing happened and we are damaged for life.

  2. Lee says:

    This is really good news and I am happy for Mrs Bellew and I pray for her health to only get better from here on out. Thank you Jesus for the favor you blessed upon this case.

  3. Janis Urban says:

    Good News and thankfully Mrs. Bellew will not have to deal with the defense any longer. Good Luck to you Mrs. Bellew, Get well.

  4. Janis Urban says:

    Do You think that J & J realizes that the Medical and Scientific Communities are catching up to what harm these Mesh devices can cause and it is only a matter of time? By the way Jane, How long do you think it will take to hear the findings of the FDA’s 3 year study that finished up in January?.

    • Jane Akre says:

      The FDA has been described as a black hole and we see numerous examples of inaction on the part of the agency. Since the FDA left it up to the mesh makers to investigate themselves, it will be a breezy day in hell when they get around to it…. don’t hold your breath. But you are right- we need to keep our eye on the situation and let the FDA know we are watching, as well as watching when they will reclassify POP mesh as Class III and requires safety assurances before it is sold. (BTW – this leaves SUI mesh or slings out of the picture, no reclassification motion is underway by the FDA for SUI mesh).

      • Msm says:

        Two of the largest studies to meet the FDA request are being conducted by AMS involving 1000 women. Now that AMS sold Men’s Health and BPH to Boston Scientific (they refused to buy Women’s Health), will the studies continue or will Endo drop the Women’s Health division ?

        Even if they drop it, it will not relieve Endo from funding the current settlement. Don’t anyone panic

      • Sue Love says:

        Hi Jane so happy to hear this, are the basic details on Ms Bellew known I.e. how many removal surgeries were done? Also I wonder about the part of the settlement that the state makes you give them is that being awarded and if so it can be appealed can’t it?

  5. Mary says:

    I use to think J&J a good company

    But just as corrupt as any other

  6. Hal Lewis says:

    Judge Goodwin is NOT going to put up with this much longer from J&J.

    They are making a mockery of the MDL system by failing to let these bellwether cases go to verdict.

    All they are doing is abusing the process and using it to stall and delay the 25,000 other cases.

    I don’t think it will be much longer before Judge Goodwin gives J&J an ultimatum: “Settle these cases ASAP or this MDL is dissolved.”

    And once that happens… there’s no going back. It will open the floodgates for 25,000 lawsuits to go forward against J&J in every Federal Court across the country.

    Who knows, maybe that’s what J&J wants? After all, they are the 800-pound gorilla in this case.

    • Jane Akre says:

      One has to wonder what large shareholders think of all of the pelvic mesh injuries. Surely they cannot be convinced that there are 25-thousand hysterical women looking for a payday…..

    • Jane Akre says:

      Does Judge Goodwin have the authority to dissolve the MDL?

    • Msm says:

      J&J was worried about the effect publicity would have on a jury. Wait until all of those cases go to all of the other courts if the MDL is dissolved. Talk about negative publicity for J&J ! There will be far too many sources to squelch them all. They better take that into consideration.

    • jade says:

      Hal – If the MDL’s are dissolved doesn’t that mean that we will wind up like the tobacco cases – most of us will be deceased BEFORE we see any compensation. Is this correct???

    • Marie says:

      Hal, what is accomplished through stalling? Could it go on for another year or more? Jane, have you seen this before? How many more Bellwethers in the MDL? Seems a very successful company would want resolve as quickly as possible. Wouldn’t moving this along and showing some compassion at this point, through quick and fair settlements, be better for them? In recognizing losses and subsequent publicity, why would a company choose to prolong the litigation? Also, case value for the very injured can pretty much be estimated now. Why offer extremely low settlements? This doesn’t harm their reputation?

      • Jane Akre says:

        In my opinion, a successful ethical company would want to do the right thing. What does prolonging misery say about their ethics and compassion? There is only one explanation, a sociopathic business model where a cost/benefit analysis is applied devoid of human considerations….that’s my opinion. As consumers, you can tell them what you think about that business model…

  7. kitty says:

    Maybe that is not a bad idea. Perhaps there are some good Criminal Defense lawyers waiting in the wings

  8. kitty says:

    Maybe that is not a bad idea. Perhaps there are some good Criminal Defense lawyers waiting in the wings

  9. PLC says:

    I totally agree Hal,

    I think J&J is using this to stall the MDL cases

    They have no intention of settling yet. They just do not want these cases in court going to verdict.

    This process would tie up the courts for many, many years and no one will ever get their day in court.

    I hope Judge Goodwin puts his foot down “NOW” as enough is enough .

    J&J may be big but the bigger they are the harder they fall.

  10. Tammy says:

    I agree Hal, Judge Goodwin seems fair and he seems he has empathy for the suffering. I pray the cases go to the home state of the plaintiff and the truth all comes rolling home. J&J is delaying the end results. I’m so happy with the verdict in Calf and WV. J&J is paying for the harm they have caused. I have been filed in WV for over three years and I just want peace and justice for all us women.

  11. Disgusted says:

    I did not quite understand your comments Hal on how the court cases will flood the federal courts if they are removed from the MDL. I don’t have a good handle on how this works – if you would explain, I’d be grateful. Did it bother anyone that the case was delayed based on the other losses and Ethicon argued that the jury would be tainted? This is odd because one of our complaints is not informing the general public of the dangers. We know how badly this can hurt others. I find it hard to believe the jury would be aware of this, unless personally affected. I have to believe the lawyer’s commercials on TV would have a larger range on the jury pool. Whether they think they’re legitimate or not is another story.

  12. kitty says:

    If the cases go to state can the truth be told re: mesh was not to be implanted and how many folks involved and Yada Yada

  13. chalres says:

    if janj has thought ahead and does want cases returned they surely have stacked the deck somehow against plantiffs but i am not a legal person, but how could it benefit janj ? i sitll have a gut feeling janj and the rest of the process is still begin slowed down by trying to find a way to weed out the cases and develope a fair and simple teir system. if settleing all theses cases now would require all removal of mesh from the market / do the mesh manufactures have other mesh on the market that is acceptable and not toxic? / janj is 70b a year revenue , i dont think the are scared of judge goodwin and i am so cynical i feel they can buy 100 judge goodwins and / or threaten them just as they did in new jersey with judge higbee but i woke up today and i am breathing gods fresh air so im gonna allow myself to have peace today

  14. All Meshed Up says:

    Ladies, let us not forget that J&J/Ethicon is not attending it’s first rodeo when it comes to Mesh cases. It has side lined more than one Hernia Mesh case mainly because their Lawyers have used the FDA MAUDE data base as a reference to Prolene Mesh getting no “confirmed” failures. Case over, no fault found.

    J&J has been so confident in their products and the FDA’s backing that they have even put Gynecological Mesh out on the market without 510(K) approval.

    We Hernia Mesh Victims who have tried for many years to get Lawsuits against J&J for their Prolene Mesh, only to be shot down time and time again, are well aware of J&J/Ethicon’s tactics. We are also familiar with the FDA coming to their defense when saying that their has been no “confirmed” damage done by Prolene. The day the FDA changes the designation of Polypropylene mesh to a Class III medical device will be the beginning of the end for mesh. Hence the stalling by the FDA to designate PP as that.

    The MDL’s are NOT set up to punish the Mesh Manufacturer. The MDL’s are set up to get as many Mesh cases through the Court system as quickly as possible and if punishing the Manufactuers was part of these proceedings then the settlement amounts do not indicate that what so ever. The only people making money from the MDL proceedings are the Lawyers. The R.I. Bard/Kugel MDL awarded most of the Hernia Mesh Victims $4500-$5000. The recent Gynecological Mesh case with 2000 women was awarded a total sum of $840,000,000 which after the Court costs and Lawyer fee’s netted those Mesh Victims approx. $40,000 each. Neither case amounts are anywhere near what these Mesh Victims needed to get back on their feet and be able to go forward in their life! And with the medical bills that they have and will accrue in the future, the result is a Mesh Victim living the rest of their life in pain and poor.

    The Mesh Manufacturers see what is coming. Not only that but they knew many years ago what Mesh was about and how it could affect the patient implanted with it. There is no other Medical Device on the market today, that is being implanted is some unsuspecting patient today, with as many complaints and as many Lawsuits as Surgical Mesh has. Whether Hernia Mesh, Gynecological Mesh or Reconstructive Mesh there is a significant complaint and failure rate that the FDA ignores. There can be no other reason for this than the FDA is paid off and complies with what ever these Manufacturers want. Is there another reason that there are no recalls or significant investigations going on? I cannot think of any.

    You women who are involved or are getting involved in Court cases against the Manufacturers are hoping that you will be awarded a sum of money that will change your life as it is now. You are hoping that the money will pay the bills, the Mortgage etc. You have more surgeries coming and Doctor’s to visit and prescriptions to get. None of this is considered when settlement amounts made in an MDL. The Lawyers get together and an amount of money that the Manufacturer’s will have to payout is negotiated. Then each Mesh Victim that was deemed worthy enough to participate is categorized according to the injuries that they sustained from the mesh. Then an amount of money is decided on by the Lawyers and the Court as to each category of damage. In the R.I. Bard/Kugel MDL if you had died, your Family got about $300,000 before any medical bills, subjugation and Lawyers free. The smallest amount awarded was $4500-$5000 where the most was about $14,000. As I have said and believe, the MDL system was NOT set up to help the Victims of Mesh. They were set up to get as many Mesh Victims through Court as quickly as possible. It was not set up to punish the Manufacturer’s for the product they made that injured the people that are sueing them. If it was then the amounts of “awards” made are a joke and an insult to the mesh injured. I would not participate in an MDL unless the Lawyer could promise awards in the mid 6 figures. That will not happen but too many desperate Mesh Victims are calling “the number on their screen” to get their “Substantial Settlement” that will never come if it involves an MDL. Yes, the Lawyers put in a lot of time and money to get the MDL into Court and to get a verdict for their clients. But the end result is a lot of disappointed, poor, pissed off Mesh Victims that now have no where to turn. The Lawyer made money for his time but he is the only one walking away happy, pain free and another MDL to look forward to.

  15. All Meshed Up says:

    One last thing about J&J/Ethicon and the FDA. Bruce Rosenberg has presented video evidence that J&J/Ethicon knew 10 years ago that there was a problem with their original version of Prolene mesh. It was the smoking gun that should have been seen on 60 Minutes and Fox News. Nothing has ever been done as far as we can tell. It was the same for the DOJ and the U.S. Attorney’s Office when they got the video. Both Bruce and I have been interviewed and provided documentation of J&J/Ethicons fraudulent advertiseing and the subsequent failures of their Mesh in ( at that time ) 300 patients to the FDA’s Office of Criminal Investigation. Nothing. Nada. Ziltch.

    J&J has the money and power to have the FDA protect them from us. The fact that we have been harmed by a Medical Device approved by the FDA and a supposedly “Benign” product makes no difference at all.

    I speak of my experiences over the past 8 1/2 years after having a Prolene mesh go bad and try to kill me and having a Bard/Kugel implanted to repair the hole. You women who are now finding yourself Mesh injured, wanting to get better and sue the crap out of the Manufacturer of your particular Mesh may have a better chance at achieving that. You at least have a much better chance than Bruce and I do. But we are still fighting multi-billion dollar companies and a Governmental Agency they apparently own and control.

    We as the Mesh injured need to join together in this fight to recieve just compensation for what Mesh has done to us. We need to cooperate with each other to change the FDA and it’s protection of the Manufacturers. And we need to make sure that the World knows about the dangers of Surgical Mesh and Polypropylene Mesh in particular. We cannot be silenced by ignorance or corruption any more. As more Lawsuits come to light and stockholders start asking questions, the Mesh Manufacturers will have to come clean about what they have known for many years.

    Best Wishes to All……..

  16. Diane Elliott says:

    Mr. Lewis, Thank you for continuing to contribute your proffesional opinions. I recently learned that mesh implanted in New Zealand, are unable to sue these mesh manufacturers. Do they have a voice with the F D A ? if not does it not keep the true numbers of mesh affected low?

    • Janis Urban says:

      If any of you know the history of mesh and how these pelvic mesh kits came into play (not invented) you know that these manufacturers were searching for a Medical Device that could be massed marketed. They had been watching surgeons for years using mesh to repair damage within an injured body. Surgeons always had a piece of mesh with them and when needed they would take a piece and cut it to size to repair organs, tissues, muscles, taking care not to place to much of this mesh. So the Bright Idea of designing Pelvic Mesh kits , one size fits all. So they have the Idea, they have there Mark, now the Buildup (the gold standard) they call it, then the push, then the HURRAHS, Now the Fallout. With their pockets full the Coverup begins. It was a well planned out con job as far as I am concerned. Not only should they be held accountable civilly but criminal charges as well, Racketeering , comes to mind, assault with intent to cause bodily harm, Fraud. It will be written in the History Books. Corporate Crimes, Commerce over Safety. The Bottom Line everyone was satisfied. There are always casualties in a con job, the Marks (victims) here are the large numbers of mesh injured which was the only thing that they did not see coming. .That is Corporate World Today. Watch Out!

      • Disgusted says:

        Well said.

      • kitty says:

        If that is the truth—-then 1/2 there country should join in the litigation. I PERSONALLY DON’T BELIEVE YOU.

      • Abandoned says:

        For some reason…I have this thought in my head that the insurance companies won’t pay damages if the defendant intentionally caused harm, criminal conspiracy or what ever it is called. This could be totally off…with no truth to it.

        I was married to a plastic surgeon and was the administrator for his practice…It seems like in our malpractice and other liability insurance…there were exclusions to harmful acts caused with intention. If this were the case (probably not) which brings up another question WHO HIRED the ATTORNEYS to REPRESENT BOSTON SCIENTIFIC and the OTHERS? ARE all of these DEFENSE ATTORNEYS BEING PAID by THE MESH COMPANIES or THEIR INSURANCE COMPANIES? If anyone can figure out what I am trying to say…feel free to transcribe in a different format…

        May God Bless Us All with Heavy Favor…

  17. Our system here is set for the people and companys with money to win and to hell with the little guy we will not. Win as we se a win.

  18. kitty says:

    Honey catches flys

  19. All Meshed Up says:

    I would not say that OUR Court system has been set up for the people with money but it sure seems to help! What I will say is that when negotiations and deals are done, in backrooms, between the Plaintiff’s Lawyer’s and the Defendents Lawyers, without the Plaintiffs input, a travesty is being performed. The fact that the Court allows this, most likely with full knowledge that the Plaintiff’s are not being consulted, should concern anyone involved in futher MDLs’.

    What most Mesh Victims do not realize is that the Lawyer they sign up with will most likely NOT be the Lawyer that goes to Court to “handle” their case in an MDL. A local Lawyer will sign up as many Victims as possible and then “sell” them to a “Big” Law Firm. That Law Firm will “buy” cases from Lawyers from several States in preperation for an MDL. That Law firms staff will review all of the medical records of all the victim’s to determine whether or not they are worthy of representation. At this point it does not matter if you have been damaged by the Mesh product involved in the MDL. What does matter is the evidence available and the status of the Victim. If you have had several surgeries in the same area of the Mesh but NOT involved with the Mesh, you will probably not get selected for the MDL or any Lawsuit against the Manufacturer unless your case is “golden”. If you have been in bad health ( but not because of the Mesh ), if you were or are a drug addict, a Felon, a Tobacco smoker or have had more than one Mesh product ( as in my case ) you will not get representation and will probably NEVER get a case against the Manufacturer of your little monster. If you do get selected to be represented in the MDL, you are categorized by the Lawyers staff and that category will determine how much of a “Substantial Settlement” you may get.

    The comment that you have to have money to get into or out of Court is correct in a lot of cases. But here is a question for you all! Does anyone know of a Celebrity, Movie Star, Millionaire or a Politician that is currently suffering from a Mesh implant? So, the REAL question should be this……Why is it that the normal, everyday person is being implanted with Surgical Mesh and not the celebrities, millionaires, movie stars or politicians?

    If you have money, you are not implanted with Mesh. That is becoming, at least to me, a very real and intrigueing subject when you consider how many people in the U.S. have been implanted with Polypropylene Mesh. But that is a subject for another day. What I am seeing is a huge number of Mesh Victims getting swept under the carpet with the help of the Court system and Mesh Manufacturers getting away relatively cheaply. That is why a fund should be set up for Mesh Victims. Just like the Fund set up for Mesothelioma Victims, there should be a Multi-Billion dollar fund set up by ALL of the Mesh Manufacturers so ALL Mesh Victims will at least be able to get some compensation. This would be an equitable way for all Mesh Victims to benefit instead of the few. The MDL’s are a cruel joke being perpetrated on the Mesh injured. After years of hoping and waiting for the money that will finally help them, they are left ( in most cases ) destitute. This in itself is a crime.

    • Marie says:

      All Meshed Up,

      Your experience is very unfortunate. Was complete removal of the first possible prior to placement of the second, and has anyone in the medical community given you hope for a better future? I’ve read good things about Dr. Raz, a transvaginal mesh expert. Does such an expert exist to help you and others with hernia implants?

      • Marie says:

        All Meshed Up – In your opinion, will it also be next to impossible for transvaginal implant plaintiffs, those not chosen for bellwethers, to receive substantial settlements or trials in the near future? What do you forsee happening to those with extensive medical documentation linking the many complications and injuries, including some that will be life-long, to the product? Since you mentioned, I’d like to add that this young woman is a non-tobacco user, non-drinker with a clean record and never in need of daily prescription antibiotic and pain medications prior to these injuries.

    • ALLMESHEDUP says:

      Due to the advice of my attorney I avoid posting due to the fact that the Defendants want all copies of anything posted on websites or blogs. Have any of you had to provide any postings of what you have written on a website? I’ve been through so much of the same things most every woman is experiencing and have been left disabled by this mesh. Just wanted to see if others have had the same request from their attorneys to make sure you keep copies of all posts or refrain from posting. Blessings and I pray this MESH is outlawed and the manufacturers are held accountable to every women they’ve hurt due to their negligence and no warning of any complications.

  20. David says:

    The big mess the FDA has on its hands, in my opinion, cuts straight through the 510(k) illusion of safety and effectiveness –to its core reality: the 510(k) clearance process is, via its “substantially equivalent” (“SE”) standard for comparison, fundamentally flawed by legislative design.* Therefore, “the TVT-Abbrevo remains on the market,” (to create its ongoing “unreasonable [threat] of illness [and] injury” (21 U.S.C. §360c(a)(1)(C)(II)) until the FDA responsibly acts to “rescinded [its “SE”] decision or has barred [the next “SE” surgical mesh] device covered by that decision from the market through other legal actions”.** And, if the FDA does indeed carryout and then succeeds in reclassify a non-“SE” 510(k) predicate device with a “significant change in the materials, design, energy source, or other features […] from those of the [remain 510(k)] predicate [devices]” (21 U.S.C. 360c(a)(1)(B)), as a Class III device,*** it would then, via a black box warning, also need to make a non-“SE” surgical mesh device – through its labeling – fit for its intended use with accompanying contraindications (to propagate only its future, responsible, real-world surgeon use).

    * The first half of Conclusion 7-1, from the Institute of Medicine’s July 29, 2011 (released) FDA sponsored report: Report: Medical Devices and the Public’s Health, The FDA 510(k) Clearance Process at 35 Years (hereinafter IOM Report), stated: “The 510(k) clearance process is not intended to evaluate the safety and effectiveness of medical devices with some exceptions.”

    ** This is because “a 510(k) decision made by the FDA creates a precedent that is legally binding on the agency” (IOM Report Finding 2-3).

    *** Reclassification success = because the remaining “SE” polypropylene (PP) surgical mesh 510(k) predicate devices do not have “the same” (via 21 U.S.C. § 360c(i)(1)(A)(i)) “significant change in the materials, design, energy source, or other features of the device from those of…” the unreasonably dangerous reclassified, Class III, PP surgical mesh device(s).

    More significantly, however, as it would relate to the reclassification of the TVT-Abbrevo mesh device’s understood 510(k) unreasonable risk of illness and injury –it is within the greater contextual failure of the three-tiered, purported current risk-based “classification [system] of devices intended for human use” (21 U.S.C. §360c(a) to mitigate unreasonable risk.

    In the Feb 10th, 2015 MDND Newsletter story, by Halley B. (Hal) Lewis, III, of Fonvielle Lewis Foote & Messer, entitled “The Difference Between Hope and Despair – Same Facts, Different Way of Telling a Story,” in my reply post at #43, I would like to clarify something I wrote in regards to IOM Report Recommendation 7-1. I believe it may have been misleading to “the big picture,” paradigm shift regulatory approach solution. “The answer,” via IOM Report Recommendation 7-1, I understood when I wrote it (although failed to articulate this when nagged by it then too) was through the very limited scope of the IOM’s task (as it was narrowed, via the “lens” of the two principal questions) – with the end result of restricting “the big picture” into a Class II “corner of thinking”. But “THE ANSWER,” I think, removed from this previous mindset entrapment – set free within in the bounds of a new, greater framework conceptualization approach – is to eliminate the Class II risk classification altogether…as it, I believe, is the root cause of THE PROBLEM.

    This Class II root regulatory problem, I think, was also partly – although not cohesively understood – when simplistically still understood by Peter Barton Hutt with Covington and Burling, LLP (from the 70’s and 30 plus years later again non-coherently) as explained during his June 14, 2010 speech at the IOM’s workshop on The Public Health Effectiveness of the FDA 510(k) Clearance Process. (NOTE: Mr. Hutt was one of the architects of the 510(k) process.)

    To quote Mr. Hutt, from the section, Welcome and Opening Remarks – Legislative History of the Medical Device Amendments of 1976: “The Class II has always been the easiest. And I probably spent less time focusing on Class II.”…“At one point in this process I considered getting rid of Class II. Because I didn’t honestly think FDA would ever have the resources to propagate standards.”…“But I keep Class II for a reason that probably would not occur to you. I was concerned in the classification process, that if there were only two classes, a lot of Class I devices which shouldn’t be subject to premarket approval would get shoved into Class III. And, require premarket approval. So I keep Class II as a buffer. As sort of…I…well I am not going to use that term….As just as a convenient place to put things that are halfway between general controls and premarket approval. And I wasn’t concerned about adequate control over those devices because, as I will come to in a moment.”….“Because my job was to make absolutely certain that no device on the market or coming on the market that could present a public health problem that the FDA couldn’t deal with. That was my focus. And that’s why I wasn’t as much concerned about Class II.”

    In the question portion of his speech Mr. Hutt, in response to a question, further elaborated on his “primary focus”: “My primary focus actually wasn’t on what has become 510(k). It wasn’t on Class III. It was on making certain that FDA had the regulatory authority to do what ever was necessary to make sure that devices are safe and effective.”…(This FDA regulatory authority is only after legally binding “SE,” via caveat, not preventively with pre-market action.)…“That was the focus. Indeed, I made certain that the legislative history of 510(k), in the final documents, say….There is a very famous paragraph that says ‘substantial equivalence’ does not refer merely to technological characteristics of a device. It refers to safety and effectiveness.”[****]“The other part of the problem is you want to write the legislation so that it focuses the attention of the agency – to give them the opportunity to deal with the most significant public health issues. Not all products are created equal.”…As “SE” does not address the reality that one “SE” device is no less dangerous than the next non-approved “SE” device (as Mr. Hutt states below) – the FDA does post-market following “SE” 510(k) device clearance.

    **** It is very interesting that Mr. Hutt’s focus (current in particular) “indeed [MADE CERTAIN] that the legislative history of 510(k), in [THE FINAL] documents, [SAID…] ‘substantial equivalence’ does not refer [MERELY] to technological characteristics of a device. [IT] refers to safety and effectiveness.” However contradictory, in my opinion, to Mr. Hutt’s 2nd preliminary comment (which also, in my opinion, followed his true primary concern – his first preliminary comment: to prevent a market monopoly) was the absence of 510(k) safety and effectiveness (an add-on I “in the final documents”). I believe a market monopoly is addressed with an effective patent system, to consequently, first place the necessary control parameters around the “technological characteristics of a device” – for a future effective regulation – to progressively accommodate innovative technological characteristic change into the marketplace.

    To again quote Mr. Hutt “…devices are not drugs.”…“Devices which are after all changed repeatedly are not the same, as drugs which never change. A molecule is a molecule. But a device can be morphed into anything as we all know. And frequently does.” (“Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same” (Wikipedia)….And consequently both are fit for their same intended use –the predicate creep problem) Mr. Hutt also stated, with regards to the writing the 510(k) standard, “we used language that you will be interested that did not use the term “substantially equivalent”. What we said was it, could go on the post-amendment device, [and the new device] could go on the market if it was not significantly different.” (The “it” is problematic; “not significantly different” to what?)

    The necessary legislative control parameters around the non-significant “technological [characteristic change] of a device” (the UDI replication ring – to replace the 510(k) statute’s “same technological [characteristic]” replicating ring (21 U.S.C. § 360c(i)(1)(A)(ii)(I)) could be controlled under the principle of ‘inconsequential difference’ (“not significantly different” comparative to the FDA approved same SIU/IRU GDM (generational device model))….upon addressing the patent problem with the GDM patent system. While the significant, incremental different “technological [characteristic change] of a device (via the understanding from 21 U.S.C. § 360c(i)(1)(B)) could be controlled (via a pre-market clinical trial gateway = the fundamental reconstructed and adaptation of the PMA process) within scientifically progressive GDM advancement (via the principle of ‘effectively safer’ (‘ES’)). To thereby, incrementally raise the reasonable assurance of safety and effectiveness bar (to not be still “SE”) from the “[demonstration] that the device is as safe and effective as a legally marketed device” (21 U.S.C. § 360c(i)(1)(A)(ii)(I) – to equate the understood least risky, lower limit public health benefit control threshold parameter. And then, via a responsible use patient safety guideline lens (for creation of the inner patient health benefit threshold surround), the patient collective endpoint will then be able to “reflectively” dictate in near real-time, to an industry, their “unmet need” (relational to historical surgeon efficacy competency without current, reckless, indiscriminate long-term/permanently implanted device abuse) for quality device and non-device, individually patient appropriate disease severity/demographic healthcare need alternatives (the unmet patient need unable to be met by an industry’s risky efforts).

    Mr. Hutt, in response to a question posed to him during the question period of his speech, stated: “Let me mention one minor detail that actually is probably not so minor. The way 510(k) –and here I mean section 510(k) was written, was simply a reporting obligation. There was no authority in there for the FDA to approve a 510(k). And what you did until 1990, when the law was changed, was you simply made you 510(k) report and went on the market. So it wasn’t a gate-keeping proposition. But it was important in my mind that the FDA know all the devices on the market. And that was the original objective. It was a simple reporting of everything on the market. So that FDA could do what your suggesting [be an ‘activist agency’ not ‘passive’]…could prioritize, could say this is important this isn’t. The latest vision of a tongue depressor is not the same as a post-amendment Class III device. [*****] So it was to give the FDA all the authority it need. And then after all that’s what we all relay on. That was the industry relies on it’s what consumers rely on. Everyone relies on the FDA doing the job the way you describe.” (As the 510(k) is today, almost 40 years later, still not a “gate-keeping proposition,” the FDA is, as it has always been-per in mission statement: the gate-keeper”. How can the FDA even regulate a long-term/permanently implanted medicine device without also address current dangerous, reckless deceitful surgeon indiscriminate abuse –via the practice of medicine?)

    ***** And, therefore the Abbrevo polypropylene surgical mesh is not the same as a polypropylene Abbrevo suture. And consequently, Abbrevo’s jury determination for its lack of safety and effectiveness for the SUI indication should now also be prioritized by an ‘activist agency’ doing what everyone relies on the FDA to do: address the reality that “not all [“SE”] products are created equal,” within and across indications. (As the next 510(k) cleared mesh device may be determined dangerous while the comparator suture device may not be.) Contradictory to Mr. Hutt’s logic, “SE” fails to even “[refer] to safety and effectiveness,” as the IOM and their Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process clearly understood and Abbrevo demonstrated, via its predictably unpredictable in vivo performance as a “SE” PP device.

    I think Mr. Hutt failed to even causally link the Class II root problem: the next “SE” device’s backwards look to “the predicate device” comparator – relational to the dumping ground of “the 510(k) predicate device debris field” – instead of within a risk-mitigation approach understanding, for the future, progressive (not 510(k) regressive), effective regulation of those risky medical devices in the U.S. (understood in need of both a pre and post-market FDA regulatory understanding) for their safety and effectiveness. I believe that Mr. Hutt should have reevaluated his ongoing, outdated assumption that since “Class II has always been the easiest” to regulate – that upon the failure to have reclassified post-amendment devices – the 510(k) (never mind 30 plus years of “the [510(k)] predicate device” creep) would remain a suitable “a buffer” in which to permanently “[shove]” those devices that were not Class I devices but were also never FDA approved for safety and effectiveness understanding…What a joke!

    To escape, in my opinion, the fundamentally flawed “groundlessness” (no true risk-based threshold) of the antiquated three-tiered risk classification scheme (perpetrated against an unsuspecting American public by the FDA and other U.S. Governmental and non-governmental actors) – I envision the following four new, evolving high-risk, Class III medical device classifications for devices. (For those devices which post-market performances, have a reasonably anticipated post-market probability to adversely impact human life and subsequent, real-world, post-market adverse impact consequences, resulting in “an unreasonable [outcome] of illness and injury” for patients.)

    1. Long-term and Permanently Implantable (L-T/PI) Medical Devices: Devices which are intended to be implanted in the human body for more then 30 consecutive days.

    2. Short-term, Temporarily Implanted Medical Devices: Devices which are only intended (as labeled – to remain fit for their intended use) to be temporarily implanted, with internal use limited to less then a 30 day consecutive duration.

    3. External Use Medical Devices, with Intended Use Indicated for Sustaining Human Life, Monitoring Patient Vital Signs, Diagnosing and Preventing the Impairment of Human Health: Devices external to skin, with (an in-clinic) intended use indicated for sustain human life, diagnose patient conditions (example: lab tests), prevent the impairment of human health, and monitor patient vital signs.

    4. Surgical Tools and Limited Use Surgical Devices: Tools and devices which are indicated for use in surgical procedures which have known or reasonably anticipated risks accompany their labeled intended use and can adversely result in unintended patient outcomes consequences.

    NOTE: The above language was adapted/modified from current statute. Number four, in particular, may need some further “refinement thinking”.

    These four new high risk classifications will each require their own governance standard approaches, to subsequently, transfer their scientifically progressive, legislative control parameters over their individually designed unique and purposed –“fluid” control mechanisms. And, each of these new high risk classifications will also require their own supporting matrix constructs (although primary regulatory framework components may be able to be shared in part or whole to aid in overall interactive system efficiency).

    http://www.tvworldwide.com/events/iom/100614/

    • Marie says:

      Thanks for the information and assessments, David. You are very knowledgeable.

    • David says:

      ☺To elaborate a-little-bit longer on, the importance of, this following statement which I wrote above: …[that] the 510(k) statute’s “same technological [characteristic]” replicating ring (21 U.S.C. § 360c(i)(1)(A)(i)) [*] could [I believe,] be controlled under the principle of ‘inconsequential difference’ [‘ID’] (“not significantly different” comparative to the [FDA’s approval of a] same SIU/IRU** GDM (generational device model).…

      …It fascinates me that the Institute of Medicine’s (IOM) Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process understood the need, in their report Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years, to have paired Conclusion 7-1’s two sentences together: “The 510(k) clearance process is not intended to evaluate the safety and effectiveness of medical devices with some exceptions. The 510(k) process cannot be transformed into a premarket evaluation of safety and effectiveness as long as the standard for clearance is substantial equivalence to any previously cleared device.” The Committee’s insight, in injecting its (finding) rationale into Conclusion 7-1, was quite extraordinary. This is because the second sentence, in my opinion, is the causal link which established the inescapable reality of the first sentence: there can be no reasonable assurance of safety and effectiveness within the 510(k) paradigm. This is because there was no, via the postamendment device and legislatively is still no, effective legislative control parameters around “the [510(k)] predicate device” to equate any, (“…with some [exception]” = doubt stipulation that there may be some) coherently measurable safety and effectiveness understanding. Therefore, “the [510(k)] predicate device” is neither a suitable vehicle control mechanism to containment a ‘ID’ comparative change (“not significantly different”) and to then, subsequently reintegrate scientifically verified gain back into the next, innovatively progressive legislative language containment field. And consequently, the 510(k) clearance process should be replaced (IOM Report Recommendation 7-1) as it “is not intended […as it can not] evaluate the safety and effectiveness of medical devices….”

      I believe, that the Generational Device Model Interface Mechanism (GDMIM)*** is a suitable vehicle comparator to contain, per its Indication for Responsible Use Statement, a significant, incremental ‘effectively safer’ (‘ES’) technological characteristic change****. (The GDMIM’s Indication for Responsible Use Statement functions to legally bind both a Lead and, then 18 months later (two), Lag GDM’s same SIU, to their shared same IRU – part 1 and IRU – part 2 refinement designations.) The GDM “trace template control vessel” is needed first for an “ID’ UDI filtration into the post-market arena and then, via its significant, defining, dominant device technological characteristic trait (SDDDTCT) control parameters, the GDMIM will function to have stabilized that incremental SDDDTCT change from its Lag-to-Lead GDM reiteration. This stabilization, fundamentally allows for a causal disseminate of robustly gathered-up post-market UDI performance data (“the gain”) to be nuanced away from the GDM control template overlay (“the chaff”) – with contrast drawn between – needed to separate the variance of UDI from “constant” of comparative GDM (with “constant” evolutionarily reestablished pre-market via next generational ‘ES’ model reiterations – upon Lead GDM approvals)….(As GDM existence is not static = not innovatively left stagnant like “the [510(k)] predicate device” is at any point in time when manufacturer cited–“plucked” in part or “pasted back” together in whole–from under a past “same [510(k)] intended use”–out of “the 510(k) predicate device debris field,” for a new device’s regurgitated up “SE”…to continue the 510(k)’s “creeping, irrational madness”).

      * This was a change from the typo above….It should NOT have been 21 U.S.C. § 360c(i)(1)(A)(ii)(I) for the “different technological [characteristic]” integration.

      ** The terms Surgical Intended Use (SIU) and Indication for Responsible Use (IRU) are both new regulatory terms for the Effectively Safer (‘ES’) Regulatory Framework, which I am in currently in the process of designing, to replace the hodgepodge/nonsensical current “framework” monstrosity. (Both these terms were adapted from current regulatory language. They are “working terms”.) SIU will specify both the surgical procedural approach and clinical affect(s) or outcome(s) intended, by which a L-T/PI medical device will effectuate change on a function(s) and/or structure(s) of the human body. The term IRU will consist of two parts: IRU – part 1 which will both identify the target patient population and accurately characterize the severity of the disease or specific condition that a L-T/PI medical device is intended to treat, cure, mitigate, prevent or diagnose; and IRU – part 2 will designate the demographic segment(s) of the target patient population indicated for a L-T/PI medical device’s responsible, real-world use.

      *** The GDMIM is the control mechanism for the ‘ES’ Regulatory Framework’s outer threshold fold. It is a dynamic, evolutionally progressive, “mechanized vehicle,” which houses only one Lead and one (and then two) same SIU/IRU Lag GDMs at a time following expiration of Innovative Device Manufacturer’s 18 Month Proprietary Market Hold (established via the GDM Patent System…to address the device industry’s “stocking-stuffing syndrome”). The GDMIM moves within The Pre/Post-market L-T/PT Medical Device Interface Matrix along its legally bound SIU/IRU trajectory. Its regression is restricted, while ‘ES’ progression innovatively cultivated within the CTABBURG (The Clinical Trial and Axiom Building Block Understanding Reintegration Gateway), under the hierarchical governance of the ‘ES’ Regulatory Framework’s tri-tiered statute’s upper (The U.S. Taxpayer and Secretary [FDA] Efficiency Standard) and mid (The Effectively Safer GDM Standard) tiers. Internally within the CTABBURG’s control confines, a GDMIM’s ‘ES’ inertia is spurred by the legislative language interaction between The Effectively Safer GDM Standard’s three control attributes (The Lag GDM Verification, Lead GDM Incremental and Lag-to-Lead GDM Comparative Control Attributes). (An ‘ID’ UDI flow – via the same SIU/IRU, comparative GDM control template filter – will be governed under The Inconsequently Different UDI Standard: the base-tier.)

      With a GDMIM’s individually unique, evolutionary ‘ES’ flight along its legally bound SIU/IRU trajectory, the “fluidity” of the ‘ES’ Regulatory Framework’s Outer Public Health (potential for) Benefit Threshold Fold is “floated” upon the framework’s upper limit threshold control parameter with–integration of the next CTABBURG hypothecated, and then FDA found, innovatively progressive, ‘ES’ same SIU/IRU Lead GDM (via the CTABBURG’s “blending of law and science,” with FDA’s recognition of scientific truth, mandated in accordance to its mission statement) while–progressively “supported” by the FDA’s required verification of the current, still legally viable, least risky (‘LR’) same SIU/IRU Lag GDM. The preceding required FDA verification of the current ‘LR’ Lag GDM (upon Industry’s collective identification, via Lead GDM petition submissions), subsequently grounds or “cements the floor” of the framework, to thereby, create and then sustain, the outer-to-inner threshold fold surround. Via the RUPSG Lens (the ‘ES’ Regulatory Framework’s inner threshold fold control mechanism), the inner threshold surround then establishes the transferable, necessary reasonable assurance of safety and effectiveness understanding between – to allow for each patient’s ability (upon his/her understanding first of an unwarranted, current surgeon long-term/permanently implantable (L-T/PI) device abuse–per the historical, reflective progression of medicine NDESR metric) – to legally weigh, independent of surgeon bias and regressive training limitations (via the primary system control of The Universal, Two-Step, Implantable Medical Device Patient Informed Consent Process), “the L-T/PI medical device use/abuse consideration”.

      The (“working”) statement for the Effectively Safer (‘ES’) Regulatory Framework’s primarily functioning objective is as follows: The ‘ES’ Regulatory Framework, through creation of its inner (potential for) and outer (availability for) benefit threshold folds, will function with the intent (per its governance standards,) of regulating (via its control mechanisms), for the consideration of every legally informed U.S. patient consumer (with its primary system control), all L-T/PI medical devices legally marketable in the U.S. to a near real-time, real-world reasonable assurance of safety and effectiveness understanding.

      Note: This framework construct realm, I envision, will occur within “The Framework Interface Apparatus”: an overarching, computer generated dominion (a construct conceptualization “platform” utilizing currently available technology) housing the “regulatory machinery” (the legislative infrastructure of governance standards – their controls; the mechanisms transferring that control; organizational, quality control and data mining systems; and the primary interactive system components conceptualizing real-world implementation), needed to create the required system stability, to sustain the ‘ES’ Regulatory Framework’s two-fold reasonable assurance of safety and effectiveness threshold.

      **** The 510(k) statutory language: 21 U.S.C. § 360c(i)(1)(A)(ii)(I) “has different technological characteristics,” is defined (per the 510(k) statutory language: 21 U.S.C. § 360c(i)(1)(B) to “[mean], with respect to a device being compared to a predicate device, that there is a significant change in the materials, design, energy source, or other features of the device from those of the predicate device”. Therefore, an effectively functioning legislative framework must, in my opinion, incrementally control “a significant change in the materials, design, energy source, or other features [a device’s SDDDTCTs] of the [new] device from those of the” comparative control mechanism’s componential makeup of SDDDTCTs –(with the ‘ES’ paradigm shift: the GDMIM’s legally binding same device indication through intended use, via GDM containment “vessels,” for ‘ES’ Lead GDM integration)– used to transfer a current, near real-time reasonable assurance of safety and effectiveness understanding (via SDDDTCTs’ axiom device building block’s “shadowing” of evolving in vivo UDI performance “norms”). With SDDDTCTs predictably distinguished pre-market – from post-market change, UDI relevant–insignificant device technological characteristic traits (IDTCT/s) – via statement of what would constitute a GDM’s SDDDTCT control parameter breach: (per) The FDA’s GDM-to-UDI RVR Statement. To then, pre-market set the GDM-RVR (risk variance range) to contain the “stretch-differentiation” between SDDDTCTs and IDTCTs….And with the UDI Risk Assessment Assignment’s (RAA) equation of marketable, expectable UDI risk – deviation from the FDA approved GDM mean – still within a GDM confinement’s mitigation of patent infringement (deviation = the possible directional “innovate light” for ‘ES’ innovation – to be marketed by manufacturers…until understood differently by the FDA, via the ‘LR’ Lag GDM)….(This understanding is legally necessary to reiterate a ‘ES’ Lead GDM)….

      …IS THIS LEGISLATIVE CONTROL PROPOSITION POSSIBLE? – One has to only look at the modern day metal-on-metal hip to know that it was and is still VERY possible! With the rationale being: if the device industry can create a human health plague, via the compounded metal-on-metal SDDDTCT regurgitation from a past (or unabated again future) split of “the [510(k)] predicate device,” (my understanding derived from the NEJM’s article: “The 510(k) Ancestry of a Metal-on-Metal Hip Implant”), an industry’s COLLECTIVE (device design and marketing) EFFORTS could also have left a public health benefit “good enough” alone…when not raising the patients’ effectiveness bar from the comparative, least risky device technologies already in the marketplace. “Drumming-up” more profit, via targeted marketing, is not innovation when effort is not ‘ES’.*****

      ***** ‘Effectively Safer’ (‘ES’) is a scientifically progressive L-T/PI medical device principle which “cradles” efficacy in its innovative reach, for an increase of patient effectiveness. This principle for patient benefit will, via The Effectively Safer GDM Standard, address the flaws of “substantial equivalence” (“SE”) by not allowing the “least burdensome,” non-innovative manufacturer regurgitation of inferior 510(k) predicate device (“SE”) technologies back into the market place (via GDM control confines). In the ‘ES’ paradigm, by law, the pre-market reintegration of the current lack of patient effectiveness understanding from existing UDI performances in the marketplace, via a legally viable ‘LR’ same SIU/IRU Lag GDM, will be required FDA verified. With this FDA regulatory competency verification, FDA will proactively then carrying out its mission statement, by establishing the reasonable assurance of safety and effectiveness – needed to lay claim – for an industry’s legislatively verifiable “public health benefit” (per the FDA’s new Innovation Stage-gating Authority initiative/tool, via the CTABBURG).

      ‘ES’ logic is as follows: If a L-T/PI device is not ‘ES’ it is still “SE” (being no less dangerous than the comparative 510(k) predicate device). And, if a L-T/PI device is not “SE” but ‘ES’, it addressed the flaws of “SE,” with the patients’ effectiveness understanding. With this proposed ‘ES’ paradigm shift, the medical device manufacturer “hijacker,” of the practice of medicine, will be thrown in the back seat (…and then be left to tumble out) of Industry’s current “gravy train to market” (aka: the 510(k) clearance process) – for the patients’ purview of an industry’s past intent….And subsequently, in the future, no more “least burdensome,” “SE” manufacturer “free rides” will be given.******

      ******Via the UDI Intent to Replicate Toll (IRT), (one of the four device manufacturer payment mechanisms of the to be proposed ‘ES’ Regulatory Framework), The Innovative Device Manufacturer’s 18 Month Proprietary Market Royalty percentage (the toll) will be redistributed (in the ‘ES’ Framework), by the FDA, back to the innovative device manufacturer, with the non-innovative device manufacturer’s UDI replication through that innovative device manufacturer’s ‘ES” Lead GDM (to prevent a market monopoly, via the GDM-RVR with UDI-RAAs –to justly reward the efforts of the innovative device manufacturer)….No more time wasted in the courts fighting patent infringement battles, upon the non-innovative device manufacturer’s “riding of the coattails” of an innovative device manufacturer. The money saved on legal fees from not having to fight patent infringement could be used to buffer the burst of this current, unsustainable L-T/PI device overuse bubble in the marketplace…with burst –upon– the legally informed patients’ collective determination of responsible L-T/PI surgeon device use. (If these jury decisions are any indication, I think the device industry is in for a ruff ride ahead….Can the FDA still drive the bus?)

  21. kitty says:

    I can’t stay focused on your dissertations

  22. All Meshed Up says:

    Although I am able to follow the subject line and do get the premise, your post David is quite “wordy” for this group.

    I think it is quite obvious that the 510(K) process has evoloved into something that the FDA did not intend but did, in the end, become the super highway for getting “New!” “Improved!” products on the market. The Mesh Manufacturer’s have been taking full advantage of the 501(K) process and due to the FDA’s lack of control and management, it has become an avenue for un-tested products to go to market.

    Why the FDA allows permanently implanted Medical Devices to be approved so easily is totally beyond me. Even the sheep that were the first test subjects had their mesh removed within a few months. The sheep were treated better than the Human test subjects is one thing for certain.

    Best Wishes……

    • David says:

      I agree that my post was long….But I also think that the audience here is not just limited to “this group”. To quote William Shakespeare: “All the world’s a stage.” At core of the mesh problem is the 510(k). Its regulatory gears are continuously grinding away behind the scenes, to streamline even more device manufacturer profit opportunities into the marketplace. It is, as you say, “the super highway for getting ‘New!’ ‘Improved!’ products on the market”.

      There is no outward attempt yet to correct the failure of “substantial equivalence” – via an open, national conversation to replace the 510(k) clearance process. These mesh manufacturer defendants will payout as little as possible to the current victims they predatorily targeted, so that they can then go on to prey upon even more future unsuspecting patients. Their way of life was made, and is sustained, only upon ability to exercise their societal control over the regressively trained surgeon co-perpetrator’s undermining of a patient’s rights –to maximize mutual benefits. Their efforts will continue unabated until there is universal, true legal patient informed consent (independent of a surgeon’s marketing ability), regardless if the 510(k) regulatory problem is addressed. Surgical mesh is simply another example.

      I am sure that what these device manufacturers, the FDA and their Congressional co-conspirers are doing now, is not attempting to mitigate the risks to future patients from current, unreasonably dangerous 510(k) predicate devices in the marketplace, but instead mitigating the risks to a device manufacturer’s future opportunities. As the intent of these manufacturers, I believe, is to continue to sustain their current gain (control over the practice of medicine), to further expand the profit opportunity they exploited in the human body. What else would a predator do but inescapably act out its nature?

      …Continuing on from Shakespeare’s monologue, As You Like it: “And all the men and women merely players. They have their exits and their entrances….”

      • Janis Urban says:

        David, You are correct in that Pharmaceutical Companies have been practicing medicine. Their advertising budgets are enormous. It is on TV, Radio, Bill Boards, any Magazine or Newspaper has full page ads. So, who is going to regulate an Industry that pours money into the economy like they do. It is Hit or Miss with their products and when something goes wrong they get a slap on their little finger a small fine which they gladly pay and business as usual. The End

      • Msm says:

        Thanks David. The whole issue of device clearance is mind-boggling.

        One of the current priorities of the FDA, is to expand post-market surveillance. This will not only streamline the process of getting a device on the market, but I believe it will encourage manufacturers to do less pre-market testing and to pass even more dangerous products past the 501(k) process. Also, I believe it will decrease the liability for a manufacturer if these post-market studies are sanctioned by the FDA. The FDA can’t be sued so no one will be held liable for the injuries and deaths caused by products rushed to market.

        Also, what revolutionary devices have been “approved” by the FDA and how many have been “cleared”? I haven’t heard any news of new devices that were delayed by the FDA approval process. If the purpose of the 501(k) clearance is prevent life-saving products from being held up awaiting FDA approval, what products are being held up? Or does the FDA’s approval process even exist? There should be a congressional review of the FDA and the medical device division.

      • kitty says:

        I do like Shakespeare “to thine own selves be true Yada yada”

      • Disgusted says:

        As Hal has pointed out, if the FDA had approved the product we would not be able to hold the pharmaceutical responsible. There is a flaw there as well – many products are approved by the FDA that have no better outcome than the mesh. The FDA needs a total re-hauling. There is no objective component in any of the pathways for a product to be approved. We need 3rd party (independent of the FDA and pharmaceuticals who have no financial ties to either) testing. This is the only way to be fair and objective. Unfortunately not a lot of money to be made doing it that way, at least a lot less. So sad that people are just a commodity.

    • Janis Urban says:

      For more then a decade Congress and Senate Committees have been holding hearings on the 510(k) approval process and it’s obvious they haven’t accomplished a damn thing. There own Scientists (9) of them warned and requested that Medical devices need stricter regulations. Lets face it the FDA is incapable of protecting our safety. Pharmaceutical Companies are to Big and the FDA can’t keep up with them.

      • David says:

        The U.S. Congress has yet to hold hearings on this current widespread, deceptive, systematic exploitation of unsuspecting U.S. medical device implant patients – by medical device manufacturers instigators – via use of their regressively trained surgeon co-perpetrators. At hand, is an industry’s deliberate undermining of U.S. patients Constitutional and Human rights, with intent, (I believe) to exploit a profit opportunity in the body of a non-legally informed U.S. patient. This intent, I also believe, will be reveled consistently, in open-door Constitutional hearings, across device indications.

        What universal legal patient informed consent would become: Every legally informed U.S. patient would only want the least risky device reasonably, competently surgeon implanted. Never mind the “SE” “safety and effectiveness” misconception. –Without this current “SE” device cover, what an “unfair” monopoly the marketplace would become for manufacturers without the least risky devices…when unable to breakthrough “patent firewalls”. And how disruptive to an industry’s self-promoted “gold standard” of standard of care –when a surgeon co-perpetrator (currently insulate from malpractice liability) would be unable to carryout his/her own best practice of medicine….Because patients would be unwilling to sacrifice their life-time of safety (or to be knowingly exploited) compensatory to an industry’s success in regressively training surgeons to collectively act out their primitive, patient abusive behavioral norms.

        • David says:

          NOTE: I meant to say “Every legally informed U.S. patient would only want the least risky device responsibly, competently surgeon implanted.”…Although reasonable is responsible — “being within the bounds of reason”.

          • Janis Urban says:

            There has been lots of discussions and hearings in congress re Class 111 Medical devices. Starting with the 1976 Medical Device Act and S.540 H.R. 1246.The Medical Device Act 2009. It started with something to do with the state Tort laws and congress had to amend the act so people like us could sue. There was witnesses at numerous hearings of these hearings presenting evidence of defective medical devices. There was one hearing when Ted Kennedy became ill, it was laying out everything that was wrong at the FDA and the Industry. But not much came out of it. My point is that everyone in congress and senate and the committees no the truth and 510(k) approval regulation , Class 111 classifications unsafe medical devices on the markets.. They talk and talk but nothing is done. All the hearings I have read were really to the point of safety regarding medical devices. It’s the do little or nothing Congress and Senate.

  23. Abandoned says:

    I have never been involved in a lawsuit before and have little understanding of how the Judicial System works. Does anyone know if there is still a time frame for filing from the date of injury? I used to know the proper wording or term for this…and now it has escaped me, as has so many other words. Does anyone else feel like their ability to communicate, process incoming information and retrieving information from their memory has been effected since their implant? My ability to communicate, problem solve, empathise and connect with others in the past was in the 80 percentile for people my age…today, it is like someone has opened the top of my brain and poured molasses inside. It I can pay a bill and write an email in one day it is a small success. I have about two days a week that are close to normal…what ever that is…

    • Jane Akre says:

      Abandoned… the symptoms you describe are very common and many experience the same thing. As far as the Statute of Limitations, my understanding is the state where you live determines the rules ie the Statutes on when you must file your lawsuit, however with tolling agreements set with the multidistrict litigation, those have been relaxed is my understanding. Please contact your law firm for a complete explanation.

      • Abandoned says:

        Thank you Jane….the problem for me personally, is that the law firm I am stuck with won’t answer any questions. They won’t explain the retainer agreement, where they are in the case, what they have done…They sat through a deposition I was promised I would not have to be involved in, Boston Scientific has requested a deposition with my daughter, and BSC has completed the depot with my implanting surgeon.

        I have turned into a reactive, hysterical lunatic ! I soooo appreciate this forum.

        • Jane Akre says:

          It is not acceptable that they not answer your questions. I expect they will accept your 40% at the end of the day. That requires some work such as keeping you informed and keeping their promises. Why do you say you are stuck with them? If they have broken your contract you may be free to go elsewhere…….Tell me who they are and perhaps we can call them together…. janeakre@meshnewsdesk.com

          • Abandoned says:

            I will call you tomorrow, or you can call me. There has been a litany of issues involving their firm, as with some of the doctors. And of course with my cognitive state…allthough, if someone makes or breaks a promise these last couple of years…I can generally repeat it verbatim. 512.828.2921.

    • Bejah says:

      Take B12 for your brain…and Vitamin D. Remember food is medicine so do not buy or eat junk food. Play mind games…whatever you like, card games, Scrabble, Poker, and do other things to exercize your brain. You are the only person that can save you.

      DO NOT refer to yourself as “Abandoned”. Positive thinking is one of our best assets and it is one we pass along to each other. Negativity will kill you so please change your site name to something that tells us who you are or where you are headed or what you care about.

      Smile. It is the best choice.

  24. Gma Rhonda says:

    How can they say these are not defective when how many have had to be removed? I found pieces of this while wiping. It had came apart on one side and was hanging like a trapeze. So painful!! Left with nerve damage and pain from pieces that could not be removed. The dr who removed said nothing I did made this happen so if the mesh was not dangerous or defective what happened? Over and over again. The whole situation from start to finish has been the biggest mistake I have ever made. I can only hope something happens fast. I don’t have much and I am close to losing the little I have. Only hoping that karma will catch up to the ones who have it coming.

  25. All Meshed Up says:

    The term you are looking for is Statute of Limitations. It is different in each State but most are 2-3 years. If you have talked to your Dr. about your mesh, come on this site or another Mesh Forum your time is ticking.

    There has been some lee way for some of the recent Gynecological Mesh cases but for the most part 2-3 years is the norm.

    Best Wishes…….

    • Abandoned says:

      Thank you…I couldn’t think of it for anything. My case has been filed in the MDL, and I was deposed on video with BSC right after my mother died. I have a copy of it too…and seriously thinking about posting it. Please be well, praying for the injured, departed, and our brave supporters.

  26. justme says:

    “Abandoned says:

    March 11, 2015 at 10:59 am

    I have never been involved in a lawsuit before and have little understanding of how the Judicial System works. Does anyone know if there is still a time frame for filing from the date of injury? I used to know the proper wording or term for this…and now it has escaped me, as has so many other words. Does anyone else feel like their ability to communicate, process incoming information and retrieving information from their memory has been effected since their implant? My ability to communicate, problem solve, empathize and connect with others in the past was in the 80 percentile for people my age…today, it is like someone has opened the top of my brain and poured molasses inside. It I can pay a bill and write an email in one day it is a small success. I have about two days a week that are close to normal…what ever that is…”

    __________________

    No, you are not alone or imaging these symptoms. They are real. Inability to concentrate. It is the body telling you that it is tired from exhaustion. It is internal from the immune system fighting off the mesh which is foreseen as a foreign object. IMO

  27. Toni says:

    I can sure understand the inabilities as well. I used to be so active, intelegent , and now this crap has completely taken over my life. Between the pain and the other affects it has ruined what I used to be. I was easy going hard working and fun loving. Now I have my family asking me were did I go. I am cranky tired worn out. And to be honest it is all I can do to not throw in the towel. I have always been a fighter and don’t give up. But this stuff has made it so tough to go through on a daily basis. I am hanging on by my fingertips to survive. I thank God when I get a day or so once in a while were I don’t feel pain. But those days get fewer and fewer as time goes by. I have an appt April 23rd with Dr Veronikis in St Louis. I pray he can help me. It is a 7 hour Drive but well worth it if I can get some relief. The Dr’s here treat me like a hypocondriak and it makes me feel awlful to even go to any doctor. When is the Medical comunity going to admitt this stuff is dangerous . Do they seriously think this many women are just making up these symtoms or do they really care?

    • Jane Akre says:

      I’m so sorry and wish you a complete recovery. Hang in there……

    • Abandoned says:

      My heart and prayers go out to you…

    • surgeryinmay says:

      so sorry toni.. my doctor treats me the same way.. i had my surgery clearance appt with my family dr of many years, well. he was a jerk.. he didn’t say hi, bye, good luck, hope surgery goes well, he said nothing… it was an awful appt. they all are.i have an appt next week with the gyn that put it in, he doesn’t believe me either (even after all the “revisions” I’ve had) i don’t want to go, but my hormones are all crazy, i went through surgical menopause because of this stupid sling. i don’t want to leave my house, i don’t want to talk to anybody. its just terrible. i hope your surgery goes well.

      • Kitty says:

        Why or Why do we put ourselves thru this abuse. We know what it feels like when we have an infection and their is something not right in our pelvic area. We have had menses, babies and all that goes with that. We know when we feel calm and well in our pelvic area. Why do we subject ourselves to these quacks? One went as far as saying that the pelvic cramping is constipation. The collusion with AUGS and the MDs must come to a end. Not to mention the simbiosis that Richard mentions between the FDA and Companies.

  28. Richard Howden aka All Meshed Up says:

    Dear Ladies, I know exactly what you are talking about. It is very difficult, in most instances, for our friends and Family to understand what we have and are going through. It is difficult for them to understand especially if your Dr. is saying” The pain is all in your head”,” this is the normal process of healing and you will get better”,” here take these ( put your particular narcotic here) and call me in 3 months” etc, etc. Having the Dr./Surgeon lie to you or “omit” facts that impact your health is just one part of being a Mesh Victim.

    I have a constant dull ache around the surgical site that veries in intensity. I have the sharp sudden pain that will just about double me over. I have days when all I can do is take pain meds, a cold pack/hot pack and curl up in bed and wait for the pain to go away. Years after the the original surgery I still have these symptoms. I cannot tell you how many men and women I have “talked” to over the past 7-8 years that have the same symptoms of pain plus whatever their particular Mesh product has/is doing to them. Even after a “removal” you still have scarring and nerve damage that more likely than not will cause you pain for the rest of your life. God forbid that you had Mesh migration into an organ or that you have pieces of Mesh still “floating” around in your body. Once you have been implanted with a Mesh product, you will never be the same as you were before the Mesh.

    Jane has documented many stories of the Mesh injured that have common themes of pain, loss of friends and/or Family, loss of livlihood, bankruptcy and all that goes with it. These facts are what we understand as the Mesh injured. Many of us “look” normal most times and are able to go about our daily lives despite the syptoms but always in pain. It is very difficult to convey that to someone who cannot or will not understand.

    I would hope that those facts, along with the injuries and past/ future medical expenses would be part of any settlement negotiation. The Manufacturers are not really being held responsible for the damage their products have done. If they were, the FDA would be recalling Mesh products TODAY and none of us would have to worry about medical care or money again.

    Best Wishes………

  29. confused and afraid says:

    Jane, I wanted to thank you again for all you do, for the Mesh Injured. Can you tell me if you had the interview with Miklos an Moore? I have the tvt secure, and it still remains in my body. I have sent my records to Miklos and Moore, and they have quoted what it would cost to have it removed. Because they are not in contract with my insurance (Blue cross Blue Shield) it will cost me way more than I can afford, not counting travel expenses, as well as expenses for having to stay at least a week in Atlanta. Is there any other Doctors that specializes in mesh removal that are in contrat with my insurance, that you may be aware of? I do not trust many doctors, and I am afraid to go to just any doctor for this surgery. Miklos and Moore has a lot of success with this surgery, but I do not understand why they are not in contract with my insurance?

  30. DEBORAH says:

    How many bell wether trials does it take, after years of evidence, that the stuff is worthless?

  31. surgeryinmay says:

    Dear Richard, I am so sorry..you have been through a alot too.. i catch my self daily printing off pages and pages of comments from these poor people. I think i’ll give them to my family and very few friends, that I have left. I think surely they’ll read and realize it is true. The last couple of days for me have been pretty good,except i’ll get this terrible, sudden jab that doubles me over, It hurts really bad, it scares my kids, because I yell out. i really think it’s because I have passed several stones and several slivers/shards of mesh, i seen it in the toilet and got it out. I have pictures of it all. Its awful.I think is “this Hell over”? I know deep down its not. Why would they still make this crap, and why do people still have it done. IS THERE PEOPLE THAT DO NOT HAVE PROBLEMS?? I know some of my friends have a bladder sling, don’t know what kind, but they say they don’t have any problems.. i just keep thinking its just a matter of time.

    I have a question about the statue of limitations.. i live in TN, had the miniarc in2011,3 months later my problems started (I had no idea it was mesh related) 2012 had ovaries and tubes removed, 7 lymph nodes removed from groin(dr said cat scratch fever,but I have yet to see documentation of cat scratch fever) several cystoscopies, 2013, removal of bladder stones, erosion of mesh in bladder wall, vaginal wall, “little bleed” in bladder, 2014, mesh excision, bladder stones, mesh migration, mesh erosion, that same night I had emergency surgery for a “little bleed” in my bladder, I thought i was dying.truly dying, nobody would help me, I’ve never had that much pain in my life. My hospital record said that I was having a anxiety attack and gave me a shot of versed. Anxiety… that is crazy. They were killing me.The catheter was full of bright red blood and I had a huge painful knot on my bladder.

    They sent me home with my hematocrit 21.

    I’ve seen a local attorney. I’ve called , emailed, the paralegal finally emailed me and said she couldn’t do anything until after my surgery in may… is this True?, I have no idea about anything v,I thought that this one attorney was going to be My attorney, I didn’t want to do class action. I don’t even know what they are doing.

    Can someone tell me if I have a case? I’ve never had an attorney for anything I’m in my early 40s. I’m not a mean person, but this Mesh Maker has injured me, it has hurt my life, my husbands life, and my poor kids lives. They need to quit making them, quit using them and be held accountable.

    I am sorry this is so long, and my words are probably wrong. Everything is wrong with me. My mind, my body, and my heart, it’s all a disaster. Just bare with me.

    Thank you all.

  32. Richard Howden aka All Meshed Up says:

    Thank you all for your kind comments and wishes. Really, I consider myself very lucky as compared to the many people that I coorespond with. Yes, I am in pain a lot but I am up and walking. I try to do as much as I can every day and try not to get bummed out about it all. It has been so long since the first surgeries and back then I was very depressed. I then realized that I could not allow myself to go through my life like that. Suicide was an option I thought about a lot. After I got involved with the Hernia Topix page and Bruce Rosenberg, I made a conscience decision to stop feeling sorry for myself because there are so many Mesh Victims out there in much worse health than I. I try to inform Mesh Victims of what to do and what to expect if they have been implanted or their Dr. is suggesting it.

    My life has been totally screwed up since Mesh was implanted in me in 2006. But when I talk to other Victims, many from other Countries and background, I am fulfilled because I hope that I have helped. Too many people have been lied to as I was. Too many people have had their world turned upside down because of a little piece of plastic. In some small way I hope to stop this. Whether by helping make a decision not to be implanted or by helping stop the Manufacturers of Mesh do further damage, it seems that fighting Mesh has become a mission for me. Nothing can be done for me but if I can make a change for someone else, then I am doing good in the world.

    Best Wishes to you All……………………..

  33. justme says:

    Call all of the attorneys defending the mesh victims listed on the home page of this website under trials. These are the type of attorneys you need, right? Don’t like one, hire a different one.

    Only a practicing attorney can give you the advice and answers you are asking about.

    You need an attorney already familiar with the mesh cases to make sure your type is being tried in court or on the list?

    There are many to choose from on this site. SOL is a factor so get busy, one says no, call another one.

  34. justme says:

    “confused and afraid says:

    March 12, 2015 at 3:36 pm

    Jane, I wanted to thank you again for all you do, for the Mesh Injured. Can you tell me if you had the interview with Miklos an Moore? I have the tvt secure, and it still remains in my body. I have sent my records to Miklos and Moore, and they have quoted what it would cost to have it removed. Because they are not in contract with my insurance (Blue cross Blue Shield) it will cost me way more than I can afford, not counting travel expenses, as well as expenses for having to stay at least a week in Atlanta. Is there any other Doctors that specializes in mesh removal that are in contrat with my insurance, that you may be aware of? I do not trust many doctors, and I am afraid to go to just any doctor for this surgery. Miklos and Moore has a lot of success with this surgery, but I do not understand why they are not in contract with my insurance?”

    _______________________________________

    How much did they say it would cost and will the insurance company pay any of it for out of network?

    What state do you live in?

    • Me says:

      Dear confused and afraid,

      I went to Dr. miklos and had mine removed. It was excruciating. Don’t go alone and don’t plan on comming back for at least a week, at the least! You need to stay near incase you have issues. Dr. miklos was courteous and knowledgeable (WARNING: HE IS NOT ALL FUZZY AND WARM, AND HE LACKS EMPATHY. in fact, he is very rushed and undeniably jam packed with patients and clearly has no time to spare. He was able to remove the entire sling but my vagina looks like a slaughterhouse now. I have been having shooting pains down my leg, am not urinating properly and about 6-8 months afterwards I began having a cramping tugging sensation in my buttocks just as I was befor the removal, (as well as many other issues) ,but his nurse tells me over the phone it’s not from anything having to do with the surgery. In other words he doesn’t think he could have done anything wrong during my surgery… If he were to address my new problems it would mean he would have to admit he didn’t do a perfect job, and trust me after you meat him in person, you will understand. I also want you to realize he was on “The Doctors” show a few times and he told me himself, he uses the sling, he said it is a godd devise, he told me he didn’t beleive it was a faulty product, but more of implanting physician error, (inserted wrong, maybe) I’m not sure and he didn’t elaborate.. Now he is doing research and stats and seem to be changing his tune a little after seeing the sheer # of patients he sees needing it removed, you would think he would be a huge advocate for not using mesh, but if you listen carefully when he talks, he never says a bad word about the product/mesh, he is very savy and clever at hiding any opinion on mesh. He never implies at any time that mesh is not compatible with the human body and should not be used. He side steps around that part of the issue obviously still needing to remain on the good side of the manufacturers. Just remember mesh is permanent and although he may be able to get it al, it will not be without removing alot of your tissue with it, they have to basically carve it out of your body and your vagina will never be the same. That all being said, I no longer have the evil thing in my body, but the damage has already been done, my body had already made adjustments for this foreign object and there is no turning back time with your autoimmune system and tissue ingrowth. I wish you luck but I won’t sugar coat it, it is not an easy surgery. I have a deep seated hatred for Boston Scientific now, that I can’t seem to let go. Prayers to you on your journey.

  35. Richard Howden aka All Meshed Up says:

    Hello Marie, my first Mesh was removed though for some reason the Surgeon left the Titanium tacks in that have now bunched up around my femoral artery. And as far as Dr’s go, no, no one wants to operate on me unless it is an emergency such as the Kugel ring breaking inside me. The 2 surgeries I just went through to cut out the infection was as close as the Surgeon wanted to get to my Kugel. He did say although inflammed and covered in scar tissue He could not see any breakage or indication of any mesh migration. The tacks are around the femoral artery and the kugel is installed right in the same area causing mass scar tissue and no way to identify the artery while cutting through it. So, I am stuck with my little Mesh monster for the duration. As I have said in my last Post, I am a lucky Mesh Victim compared to most. And for that I am Thankful.

    Wishing you All the Very Best………

  36. justme says:

    surgeryinmay says:

    March 12, 2015 at 4:59 pm

    Dear Richard, I am so sorry..you have been through a alot too.. i catch my self daily printing off pages and pages of comments from these poor people. I think i’ll give them to my family and very few friends, that I have left. I think surely they’ll read and realize it is true. The last couple of days for me have been pretty good,except i’ll get this terrible, sudden jab that doubles me over, It hurts really bad, it scares my kids, because I yell out. i really think it’s because I have passed several stones and several slivers/shards of mesh, i seen it in the toilet and got it out. I have pictures of it all. Its awful.I think is “this Hell over”? I know deep down its not. Why would they still make this crap, and why do people still have it done. IS THERE PEOPLE THAT DO NOT HAVE PROBLEMS?? I know some of my friends have a bladder sling, don’t know what kind, but they say they don’t have any problems.. i just keep thinking its just a matter of time.

    I have a question about the statue of limitations.. i live in TN, had the miniarc in2011,3 months later my problems started (I had no idea it was mesh related) 2012 had ovaries and tubes removed, 7 lymph nodes removed from groin(dr said cat scratch fever,but I have yet to see documentation of cat scratch fever) several cystoscopies, 2013, removal of bladder stones, erosion of mesh in bladder wall, vaginal wall, “little bleed” in bladder, 2014, mesh excision, bladder stones, mesh migration, mesh erosion, that same night I had emergency surgery for a “little bleed” in my bladder, I thought i was dying.truly dying, nobody would help me, I’ve never had that much pain in my life. My hospital record said that I was having a anxiety attack and gave me a shot of versed. Anxiety… that is crazy. They were killing me.The catheter was full of bright red blood and I had a huge painful knot on my bladder.

    They sent me home with my hematocrit 21.

    I’ve seen a local attorney. I’ve called , emailed, the paralegal finally emailed me and said she couldn’t do anything until after my surgery in may… is this True?, I have no idea about anything v,I thought that this one attorney was going to be My attorney, I didn’t want to do class action. I don’t even know what they are doing.

    Can someone tell me if I have a case? I’ve never had an attorney for anything I’m in my early 40s. I’m not a mean person, but this Mesh Maker has injured me, it has hurt my life, my husbands life, and my poor kids lives. They need to quit making them, quit using them and be held accountable.

    I am sorry this is so long, and my words are probably wrong. Everything is wrong with me. My mind, my body, and my heart, it’s all a disaster. Just bare with me.

    Thank you all.

    +++++++++++++++++++++++++

    Call all of the attorneys defending the mesh victims listed on the home page of this website under trials. These are the type of attorneys you need, right? Don’t like one, hire a different one.

    Only a practicing attorney can give you the advice and answers you are asking about.

    You need an attorney already familiar with the mesh cases to make sure your type is being tried in court or on the list?

    There are many to choose from on this site. SOL is a factor so get busy, one says no, call another one.

    +++++++++++++++++++++++++++++++++

    If you tell them you want your case single and the other 100,000 are class action, that won’t help you to find an attorney. Let them tell you what is best in your situation. Do this possibly before you have the next surgery. I am not a doctor or lawyer, just giving you IMHO.

    Seek professional help from a licensed attorney.

  37. justme says:

    Dear All Mesh Victims:

    This is hard to write and will be even harder for you all to believe. Your Doctors (mesh victims always have seen more than one, more than two and at least three plus doctors since having the implant surgery), are never going to side with mesh victims no matter what state or country you are in, or what type of doctor you have, Pain Management, ER, General Surgeon, PC, Psychiatrist, or Specialty.

    It is NOT you. It is not all in your head. It is a game to them. Stop blaming yourself. Stop blaming yourself.

    • Jane Akre says:

      However, they will side with you when facing medical malpractice charges…. which is increasingly happening. Doctors, please understand, you will be held accountable for using mesh that goes wrong. Might give that a second thought, even if you have amazing skills.

    • Marie says:

      Some medical providers are not sympathetic or are afraid to admit mistakes or go against their peers, which is very unfortunate. Through the hurt and negative experiences, we need to remember and credit the many urogynecologists, pain specialists, and others providing support and good care.

  38. surgeryinmay says:

    thank you Just Me… I feel so dumb.. all this attorney stuff just makes me so nervous, i want to make sure i do the right thing.

    and YOU are so right about the dr’s…(the doctors i have seen) yes, I’ve seen many. my family dr of many many years doesnt think its mesh, the gyn that put it in says “no way its the sling”, the urologist, “its not mesh, i got what i seen”, the urogynecologist, says “i got it all and the right anchor, here take this hydrocodone every 4 hrs to have quality of life, if you don’t take it your not going to feel better, I’ll see you back in 3 months” taking a pain pill is not quality of life for me, he blames the gyn, says he put it in wrong, but i shouldn’t be having pain and infection. – Idiots.. they are all idiots.. I want to cuss every one of them.. i want to scream at them and ask them what if i was your wife, or your daughter or your granddaughter would you treat them like you are treating me…

    I keep remembering my first visit with the urogyn, he was so nice, he patted me, he seemed very sincere, said it was the mesh, said it had to come out, he said that he was on the “national registry for mesh removal, women come from all over to see me” He said you need to talk to my lady that handles the paper work, we’ll take care of everything for filing a claim, i wouldn’t have to do anything but have the surgery. I said UM. I really need to think about this. i should have came home and googled HIM..googled mesh complications, mesh lawsuits, but I DIDNT. i DiD NOT know. i have yet to see where he was on a national registry, whatever the hell that is when it comes to mesh removal…. I was sick. i wanted to feel better. i had no idea that more surgeries would hurt me, i had no idea about lawsuits, i didn’t know anything about the fda. all i knew was sickness and pain. i went back to him, his whole attitude was different, my husband and kids went with me, i told him i wanted to have surgery and i would like to talk to his ins. lady, he said, oh your too late, thats over with…you missed out… I guess he was trying to tell me something..i still believe he was working for the mesh maker, and he was mad at me and didn’t help things at all.

    So here i am today, worse… way worse…i want us all to feel better! i want to walk, run, dig in my gardens, set my flowers out, swim,sweep,vacuum,mop, clean my toilets, my gosh there is so much i want to do..

    I will be going for surgery 3,000 miles away to see a real caring, compassionate ,doctor that i truly believe will remove All of the mesh and repair all of the damage that the mesh has done to me. I know this won’t be easy, but Dr. Raz gave me Hope…He believed me.. and that means a whole lot.

    thank you all for reading.. ya”ll are all I’ve got… I’m sorry that i get carried away on my posts.

    i hope each and every one of you have a good weekend.

    • Janis Urban says:

      Well I feel so sad for all us that suffer so much agony and despair. I finally am finished with all my pretesting and have been clear by 2 Doctor’s for my mesh removal: GYNECARE TVT EXACT SLING. On March 17, 2015. The road taken to get to this stage has been long. I have been seeing Dr. Christopher Rooney, Urogyencologist, Summa, Akron City Hospital, Ohio since early last fall. I could walk fairly well when I first started seeing him. These days are not good for walking or standing. My Dad, before he passed made all four of us girls beautiful canes made out of the wood from trees I use to climb as a child. Thank God for the cane. He never doubted me that the mesh could be causing all the changes in my body. He did say that most of the mesh procedures he has implanted have not had any problems. I said but, what about me and all the other women who do have problems, with tears falling from my eyes…, who will help us. He has removed mesh from a lot of women and says the one thing that he has going for him is that the manufacturer dyed the mesh dark blue in my case.. The hardest area for my mesh removal is where the 2 stab incisions. are. I know exactly where mine are. So wish me luck that he gets all. I’ll pray for all of you.

  39. justme says:

    Marie says:

    March 13, 2015 at 12:36 pm

    Some medical providers are not sympathetic or are afraid to admit mistakes or go against their peers, which is very unfortunate. Through the hurt and negative experiences, we need to remember and credit the many urogynecologists, pain specialists, and others providing support and good care.”

    ____________________

    WHERE? WHO? THEY WILL DISMISS YOU WITH HO WARNING ON A DIME. DON’T BE FOOLED. ONLY A FEW ARE SINCERE. VERY FEW…………………………..

    • Marie says:

      Can you please copy & paste the offending comments below, Kitty? Jane Akre, have you seen any such posts? I’ve commented only a handful of times and first did so last week with friends. Is there another Marie? I’ve never questioned who people are or been rude to anyone. I certainly don’t “chime in for the losing team.” ????

      Some of us have noticed, Kitty, that you ask people who they are and why they comment. You aren’t always allowing or receptive of something positive if not your experience, and some are made to feel bad. Why ask “Who is David or Richard” or “Who is we” when everyone is welcome? Men and women should be encouraged and able to share and ask, and it also shouldn’t matter if a comment by one or a collaborative. Also, when a nice man posts here (trying to help) and then sees negative feedback and rarely a “thank you”, that is hurtful. It also discourages some from coming back.

      Since you possibly think I don’t belong, I feel the need to explain, which I never thought would be necessary on this website. Recently, I’ve also noticed more negativity in the comments’ sections because of differing experiences. I don’t understand why some aren’t genuinly happy for those who find good doctors, have positives come from revision, have decent representation, get benefits or are doing better. A woman in my family is very hurt by one of these products. Very hurt. I wouldn’t “cheer” for anything that harmed her! She isn’t okay but she’s happy for those who are.

      I’m sorry if I offended by saying that some doctors understand and sympathize. Was I to say every doctor is bad? Here is my post: Some medical providers are not sympathetic or are afraid to admit mistakes or go against their peers, which is very unfortunate. Through the hurt and negative experiences, we need to remember and credit the many urogynecologists, pain specialists, and others providing support and good care.

      “Justme”, through saying every doctor is unwilling to help and this is a game to them, is hurting. I know she’s hurting. I’m very sorry you are going through this “justme”, Kitty, and everyone. Those of us who don’t experience but see it every day know this is terrible. We can’t possibly know and feel what you do, and we don’t suffer as much, but we struggle in other ways. I wanted to give hope, especially because I’ve seen doctors be very helpful and nice to someone I care so much about. I whole-heartedly care and understand that this isn’t the case with every doctor (too many), and too many patients aren’t being treated the way they should be. That is NOT okay. That is NOT acceptable. Everyone should be heard and given the best care. There are injured men and women, caring doctors and nurses, and friends & family of injured looking for help though. When they read “no doctors will side with you” or things like “no doctor will believe you” and “this is a game to them”, they can become discouraged and give up the fight. I don’t think anyone here wants anyone to throw in the towel or give up searching for great doctors. Unfortunately for some, the injuries can’t be fixed even by the best doctors, and what is happening is not okay. It’s extremely unfortunate that these injuries occur and even more unfortunate that some don’t understand.

      • kitty says:

        MARIE–

        Just awakened with severe pelvic cramping and thought I would shoot you another text. You mentioned “some of us are wondering” about comments

        Who are these people in your clique? Yes—I am like Socrates–always questioning to get to the truth. Also—I have not asked about “who Richard. I know him over a year–we’ve had a few words–I have really got to like and respect him

      • Jane Akre says:

        Thank you Marie- Everyone here is hurting except those trying to help. Just remember the source of your misery is not each other- it is the mesh companies and their sales reps who sold docs on an experimental procedure with little regard for the health and safety of women. Let’s not take our eye off the real offenders. Thank you’all. ~ jane a.

    • Marie says:

      I felt so bad about your comments, Kitty, that I looked through mine. In the few outside of one thanking David for his research and one about some understanding doctors, I asked Mr. Lewis or Mrs. Akre questions. I couldn’t find one where anyone would consider me “cheering for the losing team”, so please do reply since you came here to a public forum accusing me of always cheering for the losing team. 🙁

      • kitty says:

        Marie. Sorry I hurt your feelings. Re: David. I do not know David except for his extremely long posts that are fragmented and hard to follow. Richard understood what I was saying and I believe he tried to engage all of us. re :

        Addison–why should I not ask who she/he is? First i noted that she was the mother. Then the husband and then the daughter. This was suspicious to me you chime in like a Flower Child from the 70. Let’s all love one another.

        but she/he clarified. So many of us have gone to many urogynocologists and we’re given the run a round and you come in w

  40. surgeryinmay says:

    Dear Janis, I hope and pray your surgery goes good.. I will be praying for you and thinking about you Tuesday morning. Please let us know how YOU are if you are able. Thank you for commenting on my posts. you words have always been nice. Big Hugs to YOU.

    I browse through “hystersisters” site, there is a very young lady on there that just had the gynecare tvt mini sling placed, she is having some pain, and pulling feelings, wanted opinions… Well, I didn’t turn my head and pass her up.. I posted exactly what i thought about MESH…. it was not good. I still don’t understand why mesh is being used. it is so sad.

    • Janis Urban says:

      SurgeryinMay: That’s the 20 Million Dollar plus question we have all been wondering despite our attempts to bring awareness of its debilitating effects it has caused so many of us. If History is any example our plight will be written. But first we have to have better regulations for the Pharmaceutical Companies that have taken over Health Care and the way most Doctor’s Practice Medicine. The Insurance Industry is no better. We need to get back to good old fashion Doctoring. Doctor’s regularly have to be certified on new medicines that have been approved by the FDA. This last certificate for my MD was for over 200 new drugs. All with so many side effects. Do we need all this drugs that cause more harm then what they were prescribe for? I think not. Lets get back to basics. I’m afraid it is a little to late for most of us but we have to continue warning others of the harm mesh can cause. Let’s pray that the medical and scientific community will find a way to help us and not cause us anymore harm. Thank you for your good wishes.

  41. MeshSad says:

    Too scaed to have mesh emoved. In enogh pain.

  42. Msm says:

    Some questions to ask before removal:

    Exactly where is the mesh?

    If you’re told its only in the area of the exposure, ask how large the entire mesh is when it was implanted?

    Is the surgeon going to remove ALL of the mesh ? Or just what can be reached? You may end up with more separate pieces of mesh making further removal more difficult.

    What does the surgeon expect to happen to the remaining mesh?

    If the surgeon tells you after surgery that he removed it “all”, ask how large the portion is that he removed. Unless it is a “mini sling”, it should be greater than 4cm (what some are recording as “complete” removal).

    A mid- urethral sling can be >15cm long. The mesh will be sent to pathology and they will have their own report that records the amount of mesh received. It may be in multiple pieces so add it up . You’ll at least know if it’s about 3cm or much greater

    Surgeons are recording notes with statements such as ” the ends were freed” and/or “the mesh/sling was removed intact/completely/entirely ” or similar verbage This may not be intentionally misleading but the surgeons way of saying he removed all he could get to.

    Ask questions. Read op- notes and pathology reports. Ask more questions if things don’t add up . It may not be that the surgeon it trying to mislead ( but might be).

    If the notes aren’t clear, the defense may twist it all around to their advantage. If your attorney is handling hundreds of cases, errors or questionable contradictions in your records may be overlooked or not persued. Be your own advocate.

    • Jane Akre says:

      Thanks msm- also access how aggressive your doctor wants to be- going in deeper may remove the mesh more completely or entirely, but there may be a risk of further injury. Different doctors have different philosophies about risk/benefit AND they have different skill sets. If he thinks he can get it all, is he capable of doing so? In other words, once removed and measured, is it the full enchilada? Also will he/she cut away dead skin around the mesh to ensure cleaner healing? What is their philosophy on that? How many removals have they done? If they don’t like you asking questions, perhaps they don’t think you will like the answers. If they tell you not to worry about something you know to be a problem for others, don’t walk- run away! Also if you get the line about “we don’t use that mesh anymore” your only question is- IS IT POLYPROPYLENE? If so, it is the same mesh. Period.!

    • Janis Urban says:

      Dear Msm, Thank you. My Doctor says the hardest area for removal is the 2 closure stab wounds. I know exactly where these stab wounds are Plus the fact that the mesh is blue. He will take pictures of the mesh in and out and preserve it for evidence. So I am hoping for a easy time of recovery. Take care everyone.

  43. zoggy says:

    You know I try to read thru all this law jargon but it is taxing. I am sick to think that the FDA is not considering the bladder slings for SUI as a reclassification only for Pelvic Prolapse? I have had 2 surgeries and now the Dr wants to remove then do a hysterectomy and put in another sling for SUI. Because I have POP and SUI. I am not going to allow anymore surgeries and Dr. Raze is 76 yrs old. These drs cannot remove this mesh 100%! It was made to be put in and not removable. The drs were not trained to remove just put in (cadaver training) what a joke. Cadavers cannot talk, walk, or have any intimate relations.Many of you may not know but you probably got a sling from a cadaver like an organ transplant. Yes its true. If you all are sitting around waiting on money to fall from the sky keep watching cause we may never see it. If we do it will not make us whole or healthy. I WANTED A RALLY IN WV BUT COULD NOT GET 1 PERSON TO RESPOND? JANE CAN WE ALL GO TO NJ AND PROTEST AT THE J &J STOCKHOLDERS MEETING. WHEN ARE WE AS WOMEN GOING TO STAND UP AND PROTEST. I OFFERED TO PAY FOR THE BUTTONS, POSTER BOARD’S, ETC. NOTHING. EVERY HEARD OF THE SUFFRAGE OF WOMEN THAT WOMEN BEFORE US WENT AGAINST. SUSAN B. ANTHONY? THEY PAVED THE WAY FOR US TO BE HEARD? WHEN ARE WE GOING TO STAND OR SIT OR EVEN LIE DOWN IF WE HAVE TOO? FERGUSON SURE IS MAKING THE NEWS AND WE HAVE WOMEN DYING FROM PHARMA CO NEGLIGENCE AND WE CANT EVEN MAKE THE NEWS? WHY? JANE CAN YOU GET ANY WOMEN TO ANSWER THIS QUESTION?

    • kitty says:

      Hello Zoggy–I would like to go to NJ or DC

      But my priorities are complete mesh removal at this time and that does take money—hotel and air fare. Do u know who is funding Ferguson Demos? From what I understand it is multi billionaire who has his own agenda on transforming the USA

  44. Richard Howden aka All Meshed Up says:

    Can’t we All just get along?? I say this in jest and to be a bit light hearted. Mesh is such a personal thing. To have someone slight you or percieve to slight you in anyway can bring out all of the pent up emotions of being a Mesh Victim. I am certainly guilty of such. But Jane is quite correct when she said that we should keep our eye on the real culprit/enemy/damn bastards( I know, Jane didn’t print that bit!) that truly injured us, The Manufacturer’s of Mesh.

    It is hard to keep a positive attitude about whatever you are going through daily with Mesh. But try each day to step back and appreciate what you DO have in your life that makes you happy.

    Best Wishes…….

  45. David says:

    To believe that this “fire” can now be put out is not reality. All that is left possible is to contain it. The FDA, the device industry and I would suspect the majority of doctors would call this fire innovation. But innovation is simply a matter of perspective. When you feel the bite of the fire and experience its aftermath, you recognize its risk.

  46. zoggy says:

    Yes Jane instead of taking it out on others how about we all get to know each other in NJ at next shareholders meeting. Does everyone really want to sit behind their computers and complain? Lets do something? ! Anything?!

    • David says:

      What I think we should all –collectively now do is file, with the United Nations (UN), an international human rights complain* against the U.S. Federal Government for violation of the International Covenant on Civil and Political Rights Treaty.** If we all work together, in a organized manner, there is not a doubt in my mind that we can openly and transparently force the U.S. Government into compliance….So that NO future, potential U.S. long-term/permanently implanted (L-T/PI) medical device implant patient will, with the FDA’s help, ever be deceptively preyed upon and exploited by the device industry’s use of its regressively trained surgeon co-perpetrators. The U.S. Government is not only currently, legally bound by the U.S. Constitution to recognize its peoples’ human rights constitutionally but under hierarchical International Human Rights Law as well.

      I envision a future implant patients’ bill of rights document***, legally bound, specifically, by a L-T/PI medical device implant patient international human rights treaty, to globally recognize the human rights of every nation’s potential implant patients. Via this treaty, there could be a direct UN patient complaint mechanism, with enforcement by the International Criminal Court, to bring these medical device manufacturer predators (and their corrupt industry leading, co-conspiring, unjustly financially enriched physicians) to justice, on the global stage, under International Human Rights Law. And a requirement, for ratifying state parties (those states harmonizing their domestic laws in accordance with newly established international patient human right’s norms), to setup a transparent national patient complain mechanism system to allow future, otherwise unsuspecting patients, to readily understand the intent of the repeat offender co-perpetrator physician: a surgeon who has difficulty putting the needs of his/her patients’ before own regressions, to deceptively prey upon his/her patients’ vulnerabilities, upon acting out that abuse.

      It begins by accurately defining the scope of the problem, followed by the necessary action to effectively address that understanding. If there are those who want to continue to complain, I think, we should all complaint together – in an effective way – so our voices will be heard in the international arena. These U.S. Courts are bound by, the “lens” of, internationally unlawful U.S. Laws setup to mitigate “the burden” on the state from this industry’s current widespread, deceptive, systematic exploitation of human beings within U.S. boarders. U.S. Courts, therefore, are not the place to find justice “…to address consistent patterns of gross and reliably attested violations of […] human rights and […] fundamental freedoms…,”* being knowingly facilitated by high-ranking U.S. Governmental officials (under the guise of “innovation”) – to create the next “public benefit” or address a current, purported “unmet patient need” – for a predatory industry’s continuing opportunist infliction.

      * http://www.ohchr.org/EN/HRBodies/HRC/ComplaintProcedure/Pages/HRCComplaintProcedureIndex.aspx

      ** http://www.ohchr.org/en/professionalinterest/pages/ccpr.aspx

      *** http://www.un-documents.net/a3r217.htm

  47. surgeryinmay says:

    Janis Urban, I hope your surgery goes well tomorrow! I will be thinking about you!

  48. justme says:

    If I caused a group tension, that was not my intentions. There are not just patients of mesh posting comments. The mesh companies also have posers or catfish posting along with the defense attorneys having their people do the same.

    I have caught them several times. It is a game. A bad one, but still a mean spirited game to see how far they can push people into talking.

    • Marie says:

      Good morning. Your distrust and anger are understood by most I think. Being treated so poorly and getting the runaround when you aren’t well (knowing something’s wrong too) is terrible. I’m sorry this happened to you, “justme”, and also to Kitty and others. I hope you understood my wanting to give some hope to those who come to this here website. Have you yet found a doctor you can know well and trust? I hope you have or very soon find, and may God bless you.

      • kitty says:

        That is very nice and generous.of u to forgive my rude behavior Marie. I think Richard had it right. happy St Pats to all

  49. Sandra says:

    If you have a good attorney they should tell you Never discuss your case on any social Media!! The Defendants have ways of searching for anything that can be used against you!! The MLS cases are heard on an individual manner. A Special Master is in place, Lien person. These belweather trials are giving the manufacturer’s facts of cases and what a jury will likely to award! AMS has set aside 830 million to start…………I have a hard time believing the person who posted either 4-6 woman based on 800,000 plus recieved pennies. ONLY YOU AND YOUR ATTORNEY knows the facts MDLS cases don’t go to court it’s a bunch of woman with similar symptons, the files are put into categories of how severe their cases are. The money is not split between how many cases from a manufacturer IT IS BASES ON INDIVIDUAL BASIS………..not everyone is going to recieve the same!! Some of you here seem uneducated on following and listening to your attorneys………….not a bashing place towards Doctors, it’s the MANUFACTURER’S FAULT!! The FDA just announce to give AMS 90 days to come up with a plan on how to take care of their defective products!! Had this products actually 2 defects since 2008. My manufacturer has/is one of the ones who agreed instead of hearing cases one by one to come to the table and settle” Punitive damages, no intimacy, more surgeries needed, infections and may be able to get compensation for surgeries in the future!! All Attorney’s get 1/3rd no more no less.

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