Albright v. Boston Scientific: One Hand Tied Behind Their Back

//Albright v. Boston Scientific: One Hand Tied Behind Their Back

Albright v. Boston Scientific: One Hand Tied Behind Their Back

judge mallet 200Readers of Mesh News Desk have seen this before.

A law firm spends millions of dollars preparing a case for trial. Expert witnesses are deposed and paid, usually $500 an hour to review documents in preparation for trial. Lawyers travel around the world to take depositions of witnesses, scientists, experts, life planners, consultants. A normal life is put aside as the legal team laser focuses on trial preparation. The lawyers who take the case do so on a contingency fee –meaning that they won’t get paid and won’t recover their expenses unless they win the case. It’s a high risk, high stakes litigation.

And then the day comes- anything can happen. And usually does. 

A collective sigh was heard July 29, as the case of Albright v. Boston Scientific ended in a Woburn, Mass. courtroom with the first jury decision for the defendant in transvaginal mesh litigation. A half dozen cases against C.R. Bard and Ethicon in different courts have, so far, generally ended with a favorable jury award for the mesh-injured woman or a quiet settlement on the eve of trial.

Not this time.

Pinnacle Pelvic Floor Repair kit

Pinnacle Pelvic Floor Repair kit

The complaint said that plaintiff Albright and her doctor were not warned about the dangers of pelvic mesh or that there were safer alternatives to address her pelvic organ prolapse and a recurrent cystocele.

Boston Scientific should have known about the complications associated with its product, according to the Albright Stamped Complaint (link).

But instead, eleven of the 13 jurors agreed that the Pinnacle Mesh Kit implanted in Albright was not defective and neither were the instructions to the end user who is the doctor.

Motley Rice and attorney, Fidelma Fitzpatrick, prepared the case for Diane Albright. After two weeks the product liability trial went to the jury Monday, July 28, 2014.

Fitzpatrick says what was critical in this case was what was not allowed to be presented as what was.  

First Fitzpatrick tells Mesh News Desk, “We are extremely disappointed with the jury’s verdict in this case. Despite that, it was a privilege to represent Ms. Albright, to give her a voice, and to allow her story to be told.”

So what was missing from the case?

522 Studies

For starters the Albright team was prohibited from presenting the critical evidence of the FDA 522 letters. In January 2012 the Food and Drug Administration send 33 mesh manufacturers, including Boston Scientific, letters ordering three years of post-approval monitoring of mesh-implanted women to chronicle their complications. Post approval monitoring falls under FDA regulation 522, hence the name.  (Here is a background story).

The 522 inquiry would have shown that the FDA had concerns about the high number of adverse event reports coming into the FDA at that time, which had jumped five-fold in just two years. It would also have told the jury the true story of why the Pinnacle was taken off the market by Boston Scientific.


Material Safety Data Sheet (MSDS)

Remember the MSDS in the Cisson v. Bard case?  The instructions that accompanied the raw resin supplier Phillips Sumika sold to mesh maker C.R. Bard was accompanied by a MSDS or instructions for use. It specified that under no circumstances were implantable medical devices to be made from that raw material.  While skeptics saw the warning as a cover one’s behind move, Bard went to extraordinary lengths to create a dummy company to purchase the raw resin, so Phillips Sumika would not know that creating an implantable mesh was exactly what C.R. planned to do with the Marlex plastic resin.

In the Albright v. Boston Science case, the MSDS, containing the same warning, was not allowed to be shown to the 13 jurors, according to Superior Court Judge Diane M. Kottmyer.

The Plaintiff believed that this evidence was critical for the jury to understand the dangers of the product and Boston Scientific’s disregard for the safety of the women who would receive its Pinnacle device.


The approval of the polypropylene mesh that went into the Pinnacle through the FDA’s fast-track 510(k) process was allowed in part only, says Fitzpatrick.

While the jury knew that the produce was cleared, the Plaintiffs were not allowed to present evidence about what was wrong with that 510(k) application process, a process that clears mesh for sale and not based on safety.That left the jury with the impression that the product was “legal” even though the Plaintiff vigorously argued that the product was not safe and was not effective. In doing so, it essentially eliminated the argument that safety and efficacy of the mesh was not assured by the FDA, since this approval process tests neither safety nor efficacy.

Also the time period the jurors were allowed to consider was 2009 and before. In that year Boston Scientific sold the Pinnacle device to the implanting hospital, Mary Rutan Hospital in Bellefontaine, Ohio.

Much has happened since 2009 including the July 2011 FDA safety alert that mesh complications are “not rare” and that mesh implant may have more risk than benefit.  Judge Kottmyer also excluded the evidence of this safety alert, and jurors were not allowed to consider the fact that the FDA found that the complications are not rare, are potentially severe, and that mesh repairs are not more effective than native tissue repairs.   These rulings kept critical facts from the hands of the jury itself and prevented a full discussion on some of the most central and critical facts in the TVM story.


Defective Product?

The Pinnacle Mesh Kit was voluntarily removed from the market on May 10, 2011. Boston Scientific sent an “URGENT MEDICAL DEVICE RECALL-IMMEDIATE ACTION REQUIRED” letter to all affected customers concerning its Class 2 recall for the Pinnacle Pelvic Floor Repair Kit because “the device may exhibit low tensile strength between the needle and suture and led to needle detachment during mesh leg placement.”

Would that not show a concern the product was defective?

Boston Scientific argued the recall was a business decision and not evidence of a lack of safety.  Meanwhile the judge allowed the defendant to present evidence concerning the safety of all polypropylene in the pelvis, including repairs with mesh kits, mesh slings, and sheet mesh used for abdominal sacrocolpopexies.

Plaintiffs argued that the case should be limited to arguments and evidence concerning the Pinnacle itself, arguing that the Pinnacle was not the standard of care to use near delicate pelvic organ tissues.

The jurors were left with a muddy record on the controversial plastic used in almost all pelvic organ mesh implants.

Expert Witnesses

Mesh News Desk reports on the  experts who appeared at this case but that information is made available to individuals and businesses who enroll in the newsletter on Page One of Mesh News Desk. Mesh injured individuals will not be charged but businesses may incur a charge for the remainder of the story. Contact  for more information or use the Paypal option on Page One of Mesh News Desk. Thank you.


By | 2014-08-04T23:40:50+00:00 August 4th, 2014|Legal News|55 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.


  1. stopmeshimplants August 5, 2014 at 7:57 am - Reply

    I feel for this woman, Ms. Albirght, the plaintiff. To think all that she has gone through and now this trial. Given these facts she had no chance. The jury needed to hear all that wasn’t allowed. Shame on our justice system.

    • Kitty August 5, 2014 at 8:27 am - Reply

      This is the USA—we have supreme courts. What is the reason she would not be allowed to take this to M

      A Supreme court?

  2. msm August 5, 2014 at 9:03 am - Reply

    Outstanding report, Jane!

    This shows a huge injustice. In essence, the jury was given only what the local giant, Boston Scientific, wanted them to know. It illustrates a court’s prejudice and calculated intent to skew evidence in favor of this powerful manufacturer. Let alone the fact that the trial took place at the court closest to Boston Scientific for their convenience most likely determined by members of the MDL board.How does the convenience of one party take precedence over the responsibility to ensure an impartial jury?

    How can any of this happen? It is a blatant disregard of human safety in favor of $$$. A patient should be able to have a surgical procedure without personally investigating every material and piece of equipment to be used. No patient is advised of the safety of each element to be used by a surgeon and it shouldn’t be necessary for patients to have medical training to interpret all of the “medicalese”. No surgeon should have to re-read every manual on every product used each time it is used to see if there are updates to procedures and warnings hidden somewhere in the fine print on the back pages of the text.

    New findings, concerns, updates, and warnings should be explicitly announced to the medical community immediately upon discovery of the possibility of injury. Manufacturers make millions while the public’s health is put at risk awaiting results of double-blind five-year studies. Other countries pull the product off the market while an investigation is conducted. The USA does this for toys and auto parts but not for medical devices.

    Mass tort reform? Eliminate the 510k process, which only exists to allow manufacturers to get products to market faster under the guise of providing great innovations to the medical community. 510k allows the FDA to hide from liability and responsibility. Force the FDA to properly test and give products full approval before marketing. Pull products off the market immediately when a defect or safety concern arises and investigate. Don’t blame the injured. Prevent the injuries!

    This entire process is nothing more than a circus carnival providing entertainment for court officials and industry giants at the cost of the health of tens of thousands of women who have already suffered and the hundreds of thousands yet to suffer. These implants are being done at an alarming rate and will increase as our population of baby boomers must seek remedies for pelvic organ prolapse and incontinence. These are conditions that are much more then an “inconvenience” as portrayed by too many “professionals” in the medical community who believe anything to do with the female reproductive organs is insignificant unless providing them with pleasure or heirs.

    Just my opinion, as always.

  3. Paula August 5, 2014 at 1:21 pm - Reply

    MAKES ME SICK!!!!!!

  4. Nonie Wideman August 5, 2014 at 3:11 pm - Reply

    I agree with MSM’s above comment ….. wondering about that judges’s impartiality….. the truth did not get presented ..the whole truth ….shame shame shame …..

  5. David August 5, 2014 at 3:48 pm - Reply

    What I think is happening is that the courts are progressively moving the “goalposts” back for the plaintiffs’ attorneys. In the aftermath of an industry’s widespread and systematic, global targeting of unsuspecting women, the reason, I believe, is so that these unscrupulous manufacturers (who have been unjustly enriched upon prey upon these women’s vulnerabilities –via deceptively undermining the patient/doctor relationship) can both keep more of their profits and sustain same, one-sided, future opportunity.

    • Kitty August 5, 2014 at 4:03 pm - Reply

      The lawyer was bad. She didn’t get the sympathy of the jury. –nothing about Ms Albrights pain vaginal erosion (who the hell can have sex with tissue erosion?) nothing about her self cathing diapers wipes smearting stool or whatever else she suffered. It was a sham

      • Jane Akre August 6, 2014 at 7:45 pm - Reply

        No lawyer can put on a case when it is gutted do you think? One has to lay the foundation to have things entered into the case is my understanding as a non lawyer…… but who really knows the obstacles they faced here.

    • msm August 5, 2014 at 5:07 pm - Reply

      David, I agree.

      It concerns me that the plaintiff’s attorney knew that the evidence would be excluded before the trial ever began. Was it too late to amend the complaint and focus more on injuries and the BS’s knowledge of the propensity for tissue damage?

      If the evidence of warning was excluded because the doc didn’t read the printed material from BS regardless of what was contained therein, why would it not work in reverse? What would it have mattered if the doc HAD read the printed material from BS, since it didn’t include adequate warning anyway? It should work both ways but worked to the advantage of BS in this case. It seems to me that the judge would have consider that the absence of warning is absence of warning whether it is read or not. There was no intent to warn.

      Now, if there was adequate warning in the documents and the doc didn’t read them, would this automatically put the blame on the doc? Not necessarily. In many cases, the company’s representative is in the OR when their materials are being used. That may or may not have been the case here, but if so, that rep would have been responsible to provide adequate warning to the surgeon and to ensure that their product was used appropriately.

      As you said, it is all about economics.

  6. jade August 5, 2014 at 5:07 pm - Reply

    Like I said before. There will be NO FAIR trials in the State of MA under this judge. This judge is a Politician. PERIOD. Where do you think a great deal of the State’s revenue comes from in the form of taxes and contributions and perks??? Can you really deny WHY, Kottmyer, would disallow the presentation of relevant facts and history that would paint BS is a bad light? Maybe our attorneys should take a good “look-see” at her “social” activities prior to this trial? Whom she met with; had lunch with; had meetings with behind closed doors??? This is such an UNbelievable miscarriage of Justice and blatant attack of prejudice on the Plaintiff!!

  7. Connie August 5, 2014 at 9:46 pm - Reply

    So sad & pathetic , poor woman this just makes me sick !! It’s like pouring gasoline on a open wound & striking a match !! She is in a living hell so I’m sure she feels like this judge just Finnished her off . I can’t begin to imagine how her & her family must feel right now . Where is the justice , where is the law , where are the people that are suppose to care for the RIGHTS OF OTHERS ?

  8. Jane August 6, 2014 at 11:34 am - Reply

    I didn’t get the BS Pinnacle that was designated defective. Mine was the Obtryx.

    And clearly if you read my surgery report it was defective.

    Why not put our surgery reports together or a list of our complications.

    This is PART OF my surgery report.

    After adequate anesthesia, patient was placed in

    the dorsal lithotomy position. There were no pelvic masses seen and a minimal

    cystocele. A weighted vaginal speculum was then placed and the vaginal area was

    thoroughly cleaned with Betadine. A 16 French Foley catheter was placed into

    the bladder and the bladder was emptied, An anterior vaginal incision was made

    approximately 2 em over the Foley catheter balloon. The area was then cleared

    laterally to the endopelvic fascia. Using the Boston Scientific transobturator

    tape technique, the applicators were then used. First the right one was placed,

    A small stab incision was made along lateral to the clitoris at the obturator

    fossa. First the right side was done and pulled through the vaginal incision.

    Next the left side was done in similar fashion. The transvaginal tape was then

    attached to the stylettes. as the stylette was pulled through on the right, the

    string attachments to the tape tore. It was attempted to sew the tape back onto

    the trocar, however. it tore a second time. as the tape has malfunctioned. After

    repeated attempts to try to salvage the trocars and the tape, it was decided to

    proceed with a second set. A new set of TOT trocars was used ETC


    Patient 1, TOT tore twice during surgery, nerve damage, mesh erosion, lymphedema

    Patient 2, Mesh erosion, nerve damage.

    Patient 3, Infection


    • msm August 6, 2014 at 11:50 am - Reply

      Wonder if they charged you or your insurance for two. That’s the exact defect for which they pulled Pinnacle off the market. If that isn’t defective, then what is? How much more trauma did your body go through during these attempts? How many complications of this type were not documented by surgeons. Wonder if the surgeon filed a MAUDE report for the adverse event.

      Juries need to understand the implications of such defects. I still doubt the jurors in this case understood what constituted a “defect”. That should come from the judge’s instructions to the jury before deliberation and the definition should be standard across all cases in which an injury is alleged to have resulted from a defect in a device.

  9. msm August 6, 2014 at 5:47 pm - Reply

    If you are interested in knowing some of the SHtuff that goes on long before the trial, have a look at this order. This is just one of the latest examples.

    The cases are almost tried before they get in the courtroom.

    • msm August 6, 2014 at 5:48 pm - Reply

      I will add that the judges ruling is in favor of the plaintiffs….for now….

      • Kitty August 6, 2014 at 7:29 pm - Reply

        msm Thank you so much for all your info and support.

        • Kitty August 7, 2014 at 8:50 am - Reply

          Ladies——this may be negative but I am sorry. I was mocked by the PA at the MDs office yesterday when I suggested the mesh may be causing my cramps. When I suggested this she rolled her eyes and looked upward in a condescending inner chuckle. I consider myself very intuitive—-why oh why did I go back to that Dr’s office? I knew better. I am now terrified to see anyone for fear I will be labeled “troublemaker”

  10. terri white August 7, 2014 at 10:34 am - Reply

    I am in pain management. At first they turned me down,said they had know information on how to treat mesh injuries. About a week later they called me back and scheduled me. My phychiatrist had made the referral and upon finding out that they had refused me.He then called the managing doctor. Every visit the PA I see reminds me that she has a bladder sling and no complications. I also have a torn rotator cuff ,due to all the leviguine I took during my first year in.Every thing is so difficult.Makes you want to scream,I have that changed nothing. I find out more everyday. It hurts to the very fiber of my soul. To see ladies like Ms, Albright be victim to yet another lack of moral standards. All in the name of MONEY AND GREED !!

    • Kitty August 7, 2014 at 2:08 pm - Reply

      It is so demoralizing to be mocked and chastised for not having the fortitude to accept the mesh as they hoped it would have been.

    • msm August 7, 2014 at 2:39 pm - Reply

      I’m sorry you being treated so poorly. I do have a suggestion that worked for me. I started looking for urogynecologists at teaching hospitals. I found one who was also a professor. A lot of their websites have appointment requests you can fill out online. That is what I did.

      Read everything you can find about him including papers he has published recently. Some docs were pro mesh but not so much now. That’s the other advantage to a teaching institution.

      I basically said I am having a lot of vaginal pain. This has been going on for quite some time and continues to get worse. I was implanted with a TVT mesh a few years ago and would like to have everything evaluated and I am hoping you can determine the problem and relieve the pain I’ve been having.

      I didn’t go into detail but made it clear that mesh was involved so he could decline before I wasted my time. It might be worth a try. Don’t settle for just a GYN. They don’t specialize in pelvic prolapse and reconstruction.

      Just a suggestion. Rejection is easier for me if online or on the phone.

      • msm August 7, 2014 at 2:42 pm - Reply

        Didn’t mean to sound so sexist. Of course the doc could be a women!

      • Jane Akre August 8, 2014 at 12:02 am - Reply

        Another question MSM,,,, when doing a TVT removal, do you do an abdominal cut to remove the anchors as well as cut around the urethra? That way it is addressed from both ends for the most complete removal possible. There is no standard of care so it is upon your shoulders to ask.

        • msm August 8, 2014 at 10:10 am - Reply

          Everyone who is facing explantation needs to discuss this specific topic with their surgeon. There’s no way to remove the entire TVT through the vagina unless it is one of the newer mini-slings. Then maybe so.

          From personal experience, I believe my explanting surgeon was doing what he believed was right from professional training and discussions but there hadn’t been enough TESTING to support that partial removal was a solution or what the results would be. AGAIN NO TESTING ! Mesh is advertised as PERMANENT AND INTEGRATED but mentions in fine print that it may require ENTIRE REMOVAL . The manufacturers doesn’t suggest how that it to be done or if it is even possible.

          I wish mine had been totally explanted. He removed as much as he could access by tunneling in along the path of the exposed mesh but the rest remains in the retropubic space trapped between my pubic bone and bladder and very close (obviously since bladder perforation during placement is not that uncommon). So, now I have pieces of this foreign material that has been found to harden and to curl creating sharp edges shifting with every move. Now there’s no way to find it except by the few surgeons who know how to use the right type of ultrasound and even then can they find the small pieces? Why aren’t more surgeons learning? That would be an admission of the need for and the difficulty of removal.

          Will erosion into the bladder be the common complication we’re going to see after partial explantation of TVT mid-urethral slings? Or will it be festering abscesses from infection in the remaining mesh? What’s next? Remember that Tension-free Vaginal Tape (TVT) is NOT being considered for re-classification as is for the same material used for POP. “The FDA continues to evaluate the effects of using surgical mesh for the treatment of SUI and will report about that usage at a later date.” (nothing after 6 years….)

          If I knew any of this, there wouldn’t have been mesh implanted and there would have been total explantation via whatever incision necessary. When I had the sling replaced with fascia harvested from the abdominal muscle, should there have been an attempt to find and remove the remaining mesh by going deeper through that incision? Probably, but there has been so much misinformation by supporters of mesh that the questions aren’t being answered or even considered. Docs have tunnel vision for ensuring the continuation of this “22 minute” procedure that can result in a lifetime of misery for the patient while there are alternatives available.

          So, I don’t know if I’ll have to live with what I have. Not sure if I can…

          • Jane Akre August 8, 2014 at 10:28 am

            MSM- I just observed a complete removal by also going through the abdominal area and working the way toward the vagina.. in other words,,, addressing mesh from both ends until it can be freed and comes out in its entirely. Apparently it does not easily break up during removal… more to come in a special report.

          • msm August 8, 2014 at 1:21 pm

            Thanks, Jane. Hopefully some women will read your report and insist on complete removal.

            If you come across anything about removal of the upper portions after the lower parts have been removed in a previous procedure, let me know. Seems it would just be a fishing expedition.

  11. Kitty August 9, 2014 at 8:37 am - Reply

    I miss you Pam why did you have to turn on us?

    • Jane Akre August 10, 2014 at 11:43 am - Reply

      Pam has been unsubscribed.~ ja

      • Kitty August 10, 2014 at 7:40 pm - Reply

        Hi Jane—I know—

  12. charles August 9, 2014 at 7:44 pm - Reply

    Msm if mentor mesh for sui was implanted 10 years agoaand partiial removal done in 2008 and stil having problems could it still be eemoved? For that matter how can any mesh be removed if it has grown into surrounding tissue? Especially prudenal and other nerves common sense is echoing in my head that it cant be done without more damage

    • Kitty August 9, 2014 at 7:54 pm - Reply

      Charles—it is food for thought Lets say three meshs’ were implanted. The Pelvicol posterior might be one of them., This mesh is make of biologics. Would it turn into a pile of scar tissue. Then the Uretex sling or whatever was removed. And then the Gyncare mesh PS is left. How do you get thru a mess like that. DIE DIE

    • msm August 9, 2014 at 8:01 pm - Reply

      Great question. That’s what I’m facing. Not sure where to go or who to trust. Too many docs willing to give it a go without experience or training specifically for explanation of mesh. I really don’t see how the small bits can be found until they erode into something. Glad my current doc is willing to admit it is beyond him.

      • Kitty August 9, 2014 at 10:03 pm - Reply

        I can’t believe That Dr Raz is the only MD is the US that can do this.

        • Jane August 10, 2014 at 11:46 am - Reply

          Yeah, I have nerve damage from the surgery I described above. The sling broke twice, sure sounds defective to me. I have nerve damage in my left leg. My Uro Gyn said she would have to have a trauma surgeon in the room if they operated on the mesh to hopefully prevent further nerve damage in that leg. Or I could end up in a wheel chair. Good to know.

          She did offer to loosen the sling as I do get stabbing pains in my side when I bend a lot. So I just don’t bend over. My dog is trained to pick up for me.

          My lymphatic system in my groin and legs also was compromised. I have lymphedema from that.

          Right now they are just monitoring the mesh erosion and hopefully that doesn’t get worse. I am trying to avoid surgery as much as possible but obviously if the mesh punctures vital organs I will have to have surgery.

          I am fortunate enough to live a mile away from a hospital that does the mesh surgery and has performed surgery for the mesh erosion.

          My leg pain and cramps gets worse when I lay down to sleep so everyday, I wake up from the pain.

          I sleep 2 hours max at a time. Can’t take sleeping meds or pain meds as they make me crazy.

          • msm August 10, 2014 at 1:48 pm

            I have often wondered why pain meds or opiods at least don’t work on this type of pain. Well, unless I take enough to be nearly comatose and that’s no way to live. Even then it doesn’t help the pain, just makes me not care about it so much. But it also let’s my anger come out because I can’t function like that. I don’t want to end up addicted to something that makes me that way so I take nothing. There times I can’t do anything but cry and then I get even angrier. There is just no escaping mesh hell.

          • Kitty August 10, 2014 at 7:08 pm

            Hello Jane That is the bad time for me too—at night.—-I do take pain meds.

            There are many facets of mesh erosion. When I was on Levaquin a couple of years ago for a bad UT infection—I became so woozy and had a complete crash to the ground—flush on my knees. I tore the meniscus in one knee and was not treated promptly and arthritis spread like a ravaging the 1 knee. Several falls later –usually when on antibiotics for UTI—– I now need a total knee replacement in that knee because of the Arthritis–and who knows what the Levequin did to me over the past few years. I guess you could call that collateral damage of transvaginal mesh placement.

            It is living hell these days. bladder spasms sacral spasms pelvic cramps and now the knee is so bad that I hobble–like a sharp knive stabbing with each step. Sorry for being so negative. My husband and I had a nice day today–we hope that we will have some good times left in life—we are looking at a new apt. It is frustrating to see the degeneration that has occurred over the past several years.

          • Jane Akre August 11, 2014 at 12:40 am

            Kitty- have you had a mesh removal? It sound like you haven’t?

          • Kitty August 10, 2014 at 7:12 pm

            You are lucky—- Jane —–to have someone monitoring your mesh erosion—Many of the Doctors are mocking patients that comment that mesh is the reason for the pain. They are monitoring for Hypomania and Histrionics and Hypochondria.

  13. Nikki August 10, 2014 at 11:53 pm - Reply

    Isn’t Dr. Miklos a doctor that removes all of the mesh?He is in Georgia..

    • msm August 11, 2014 at 8:03 am - Reply

      He does explants and he implants mesh also. Pro mesh especially for TVT.

      In their words:

      “Although the TVT sling is considered the standard of care in sling surgery today, complications can still occur. It is very important to note that it typically is NOT the mesh itself or the procedure that is the cause of the complication, it is how the mesh is placed or how the body heals around the mesh that is the underlying cause. For example, if a patient is a smoker, her tissue is not as well vascularized as a non-smoker and therefore she is at higher risk of the incision not healing well and then a mesh extrusion occurs. This is NOT the mesh’s fault and this patient is a high risk of complications with ANY surgery, whether mesh was used or not. Studies have actually shown that the TVT sling has HIGHER cure rates than traditional surgery for incontinence (ie the Burch or MMK) with LOWER complication rates. TVT sling (Gynecare, Johnson and Johnson) was the first sling of this type on the market and now many other companies have similar products such as the SPARC procedure (American Medical Systems) and others by Bard Urology, Boston Scientific, etc. All of these slings are essentially the same as the TVT as they use needles passed through the abdominal wall and an incision under the urethra to place the mesh tape sling.

      • msm August 11, 2014 at 8:16 am - Reply

        Also, although it is clear on one of their eight websites that they are board certified urogynecologists, I don’t see a certification in the necessary subspecialty:

        American Board of Medical Specialties (ABMS) officially recognized Female Pelvic Medicine and Reconstructive Surgery in Spring 2011. In doing so, ABMS acknowledged that care for women with complex pelvic floor disorders, such as urinary and fecal incontinence and pelvic organ prolapse, required subspecialty training and certification beyond that of a general obstetrician/gynecologist or urologist.”

        Because this requires specialized training and exam by the AUGS, I would think that would be advertised

        • msm August 11, 2014 at 8:34 am - Reply

          They also advocate trimming of exposed mesh and partial removal. They declare that extrusion of mesh occurs in <1% of cases. Not infected and usually not an issue except if the partner feels it.

          RED FLAGS EVERYWHERE ! Pro mesh and blame problems on the patients or implanting surgeons ( unless they are the surgeons).

          "These modifications have included the Transobturator approach (TOT sling) which involves passing needles through the groin instead of the abdominal wall and most recently the single incision mini-sling which eliminates external needle passes. Drs. Miklos and Moore have been at the forefront of bringing many of these technologies to the US as well as leading the research in them and teaching them all over the world! Because of this, they are also experts in dealing with complications seen with them and have surgeons from all over the US send them patients to take care of these"


          • Kitty August 11, 2014 at 8:46 am

            msm—very interesting info. What about the mesh “{attacking attacking attacking” Is there any evidence to Margolis’ belief? What happens to our mesh that have been sent to the lab?

  14. Kitty August 11, 2014 at 8:41 am - Reply

    Jane Akre—I had the bladder SUI sling removed this year. Pelvicol apparently dissolves into the tissue or wherever. POP remains.

  15. jade August 11, 2014 at 10:17 am - Reply

    Be very careful with Miklos and Moore – they are VERY good marketers. Way back in 2008 – they had a website that looked like it was produced by Barnum and Bailey Circus – stars flashing everywhere – FLASH components running around on every page, etc. They also stated on that early version “The only surgeons who use robotic surgery are those who are unskilled.” I don’t discount that they may be skilled surgeons, but I also think that they are MOST happy in the limelight and not the operating room! They also did not take insurance in 2008 – I was quoted in excess of $25,000 + travel expenses + lodging expenses! So, I started referring to them as M&M – don’t let the sweet candy coating fool you (marketing) after it’s gone the rest is hard to swallow (reality). They are making money from both sides – promoting the mesh from around the World and removing the mesh implanted women. Let’s face it – they on BOTH sides of the fence – they want “unskilled” doctors to put these kits in – so, that assures their “explant” business thrives and they also get up and testify that “they are one of the ONLY practices who know how to implant mesh correctly”. Great marketing.

  16. Sandy August 11, 2014 at 3:17 pm - Reply

    Can anyone tell me if there is any place if I can find out if my former doctor has been a consultant or has any ties with ams

  17. charles August 11, 2014 at 3:27 pm - Reply

    I am sorry to keep harping on the mentor mesh but i am so confused . There is a mdl in geogia for mentor and mentor has already been found defective and removed fronm the market. J and j bought out mentor. Did they just restart the small pore mentor mesh under a different name? The mentor cases were setteled in 2010 for undisclosed amt? We didnt file until 2011 and we are in the new jersey mdl against ethicon with mentor mesh that has already been found defective fore small pores. Could someone offer somethoughts. This much thinking seems to create mesh in my head. Jus kiddin

    • msm August 11, 2014 at 5:18 pm - Reply

      Charles, those are all questions your attorney should be answering. Just because a company settled some cases not all cases were settled. It’s my understanding ( or misunderstanding) that cases may have started in Middle GA, (especially if your attorney is from GA) . The cases were transferred to MDL in WV or NJ. Not sure how they decided which went where. Cases against JJ and Ethicon are filed in both. As for company buy-outs, Endo bought AMS recently and Endo is liable for all suits on AMS products old and new. My head might be pretty “meshed” up too but I think this is correct. If not, maybe someone will weigh in.

  18. charles August 11, 2014 at 5:33 pm - Reply

    Thank u msm . That does help . But i,m afraid we were ignorant about mesh liability in the firts ftil place i think we ares ares aw paying 45 percent for deaf and dumb attornyers with no phone access . Not u like most of us im afraid

  19. Sandy August 12, 2014 at 9:19 am - Reply

    Msm so if a doctor is listed on this site does that mean they have ties to AMS?????

    • msm August 12, 2014 at 10:37 am - Reply

      There is a statement at the bottom saying that they have been trained by AMS and / or use AMS products:

      ” About the AMS Physician Locator

      This service refers individuals to physicians who have agreed to be in our database This service refers individuals to physicians who have agreed to be in our database and who specialize in one or more and who specialize in one or more conditions listed on this site. Physicians are conditions listed on this site. Physicians are listed based on their knowledge, training, and skill in treating these conditions, listed based on their knowledge, training, and skill in treating these conditions, as as well as use of AMS products. They are chosen for your search based on the postal well as use of AMS products. They are chosen for your search based on the postal code information you enter. These physicians code information you enter. These physicians do not pay a fee to AMS in connection do not pay a fee to AMS in connection with the listing. Some of the listed physicians may also be consultants to AMS, with the listing. Some of the listed physicians may also be consultants to AMS, and in and in that capacity might receive consulting fees from AMS, and some might be purchasers that capacity might receive consulting fees from AMS, and some might be purchasers of AMS products. AMS has no other of AMS products. AMS has no other financial relationship with any of the listed financial relationship with any of the listed physicians. Physicians may be removed from the list at their or AMS’ request, and physicians. Physicians may be removed from the list at their or AMS’ request, and the only restriction that would exclude a physician from being on the list is a the only restriction that would exclude a physician from being on the list is a lack of familiarity with the use of AMS products. lack of familiarity with the use of AMS products. AMS is not responsible for the AMS is not responsible for the medical advice or care given.”

      • msm August 12, 2014 at 10:47 am - Reply

        Not sure why it came out so garbled. I’ll try again:

        “About the AMS Physician Locator

        This service refers individuals to physicians who have agreed to be in our database and who specialize in one or more conditions listed on this site. Physicians are listed based on their knowledge, training, and skill in treating these conditions, as well as use of AMS products. They are chosen for your search based on the postal code information you enter. These physicians do not pay a fee to AMS in connection with the listing. Some of the listed physicians may also be consultants to AMS, and in that capacity might receive consulting fees from AMS, and some might be purchasers of AMS products. AMS has no other financial relationship with any of the listed physicians. Physicians may be removed from the list at their or AMS’ request, and the only restriction that would exclude a physician from being on the list is a lack of familiarity with the use of AMS products. AMS is not responsible for the medical advice or care given. “

  20. msm August 12, 2014 at 11:42 am - Reply

    If anyone is interested in knowing if a doc is associated with, trained, and/or use Gynecare by Ethicon, check here:

    The Ethicon US, LLC Network offers you the opportunity to contact local physicians who are familiar with GYNECARE® products. These physicians have agreed to be included in our database and are not compensated for their participation, nor does Ethicon US, LLC make any recommendation or referral regarding any of these specific physicians.

    Boston Scientific copped out and refers consumers to the physician locatof on the Pelvic Floor Disorders website sponsored by AUGS. No surprise there.

    Supported by:

    American Urogynecologic Society

    AUGS Foundation

    Boston Scientific Corporation

    Merck Consumer Care

    The Foundation for Female Health Awareness

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