Defense Closing and Rebuttal in Perry v. Ethicon Pelvic Mesh Trial in Hands of Jury

//Defense Closing and Rebuttal in Perry v. Ethicon Pelvic Mesh Trial in Hands of Jury

Defense Closing and Rebuttal in Perry v. Ethicon Pelvic Mesh Trial in Hands of Jury

ethicon logoOn Thursday, February 26, Perry v. Ethicon went to the jury. After a five-week trial, jurors will decide if the Abbrevo mini-sling, used to treat incontinence was defectively designed and whether the instructions to doctors were adequate. That same day, attorneys for Ms. Perry asked for $17.2 million in their closing arguments, an attorney representing Ethicon, a division of Johnson & Johnson, presented his closing remarks to the jury gathered in a Bakersfield, California courtroom.


Thanks to Courtroom View Network to access to a live feed during this trial. The conditions imposed by the court are that the Mesh News not quote directly or show any images from the trial.

william gageEthicon attorney William Gage (of Butler Snow, same law firm as Christy Jones), is animated and incredulous – how can the jury not see through what the plaintiffs have presented in Perry v. Ethicon?

He proceeded for two hours to outline what he says are holes in the plaintiffs’ product liability case – their accusations about the degradation of the Prolene mesh used to make the Abbrevo, for example. We showed you the sutures goes back to 1969, said Mr. Gage, comparing a single strand of suture to a woven mesh implant made up of many strands. He told the jurors he is still trying to understand how it is safe for a suture and not the Abbrevo?

In chronological order, the TVT (transvaginal tape) came out in 1998, the TVT-O (transvaginal tape obturator) was launched in 2003-2004; then came the TVT Abbrevo, all made with the same ingredient – Prolene.   The TVT revolutionized surgery, he said. Before this was out, there was nothing to treat the condition of prolapse. Since 1998 there have been more than 1,000 studies of TVT, over 100 randomized clinical trials (RTC) since 1998. TVT-O was cleared by the FDA in 2003 and there have been over 60 RCT on the TVT-O, Gage told the jurors. Abbrevo, made of Prolene, was cleared by the FDA in 2010, and it was found it to be as safe and effective as the TVT-O. Mr. Gage said he’s having trouble understanding the theory that Prolene degrades. It cannot co-exist with the long successful history of Prolene as they’ve laid it out. abbrevo

Dr. Grier has been a practicing surgery for 30 years and he relies on Prolene sutures, said Mr. Gage. If they degrade, patients will die! It doesn’t degrade, said Mr. Gage. He said we saw things at the molecular level; they said it’s got to be degrading. If it degrades, there should have been wheelbarrows of evidence to show it degrades! They didn’t do it because it doesn’t degrade, he says.  Was there any evidence the material was degrading? Was it degrading where you can measure molecules coming off it?  No, it’s not there, he said.  They have the burden to show you how it degrades. They have Ms. Perry’s mesh and they didn’t analyze it. Dr. Scott Guelcher is professor of polymer science they brought him here.   He didn’t do it.

When I heard this I almost fell out of my chair, said Mr. Gage referring to Dr. Guelcher saying he had no evidence of degradation in Ms. Perry’s mesh.  Dr. Margolis had testified the mesh was under the skin and he never saw it.  Mr. Gage referred repeatedly to Dr. Margolis as “Plan B,” in other words, he was there to deliver the goods that Dr. Gulelcher could not. The tissue reaction causes the mesh to shrink, said Dr. Margolis. There is no wording of mesh degradation in her medical report, Mr. Gage told jurors.

Why did the word “lightweight” mesh disappear from the Ethicon product description on the website during this trial?  (much of the trial has focused on light v. heavyweight mesh)  A corporate representative said a website revamp had been underway for two months, explaining it away. It is what it is, said Mr. Gage.

We talked a lot about pore size. Is there anything about our mesh that they accept? Nothing, he said. It’s too heavy, it degrades, nothing! TVT has the largest pore size.  Folks, there is no evidence, we are the largest pore size, said Mr. Gage referring to Prolene.  In 2010, Dr. Klinge said the gold standard is the mid-urethral vaginal sling, the TVT.   The whole purpose of lighter weight larger pore mesh is to eliminate erosion and there is a .4 percent erosion rate with Abbrevo. Laser cut mesh the surgeons overwhelmingly preferred, said Mr. Gage, contrary to what was presented in court. In the real world, laser and mechanical cut are identical, he said.  Details matter. Gage is apparently agitated now. He admits TVT Secur is not on the market.  The Abbrevo is within the standard of care, he says.

Mr. and Mrs. Perry zip lining in Hawaii, 2012

Mr. and Mrs. Perry zip lining in Hawaii, 2012

Blame the Victim

Ms. Perry had cryoablation in 2010 because of painful periods. She had stress urinary incontinence. Her doctor, Dr. Luu didn’t even do the burch procedures. March 23 she has four vaginal surgeries for anterior colporrhaphy, to treat a cystocele, she got an Abbrevo and had a posterior colporrhapy.  The known complications of those three surgeries carry those risks.

While in San Francisco visiting with Dr. M. Tom Margolis, Ms. Perry picks up the phone to Dr. Allen telling him she forgot to mention she was having pain with intercourse. You gotta be with me, she’s in San Francisco, she picks up the phone to see Dr. Allen who she saw four days earlier, said Mr. Gage exasparated. She said she forgot to tell him she was having pain with intercourse. She forgot to tell the pain specialist she is having pain with sex.  In October 2014 penile abrasion was reported by her and her husband.  Dr. Allen found no exposed mesh, neither did Dr. Margolis or Dr. Flynn.  You have to have exposed mesh to have an abrasion, Mr. Gage says.

Ms.  Perry saw a TV ad on mesh litigation and that’s what got things going, according to the defense.  After that she went to Kauai, the big island, she is zip lining, hiking and snorkeling. After trips to Las Vegas, Grand Canyon, Sedona and San Diego. After her pelvic surgery Ms. Perry writes her energy levels are through the roof and the pain is gone and she’s been walking 4.5 miles a day, sleeping through the night and life is good, she wrote, said Mr. Gage.  What comes after that? A lawsuit, he said.

After her car accident in Las Vegas she has as team of lawyers dealing with that, he says.  Is her mesh about to erode in the future, Mr. Gage asked. Dr. Margolis told you only 5 percent of his patients need more surgery after a mesh erosion. He told you there were an unknown number of surgeries ahead. Does it cost $4,000 or $65,000 to have a surgery, asked Gage highlighting the difference estimates between Dr. Allen and Dr. Margolis. She signed an informed consent by Dr. Luu, she was specifically warned synthetic mesh may cause erosion. She was warned of the need of additional surgery, of pain, of scar tissue or poor healing. Dr. Luu knew this and warned her of this. She signed it. The informed consent warns of everything that happened to her, said Mr. Gage.

The case has shown the mesh is heavyweight, small pore, subject to degradation and shrinkage. When Dr. Luu was a defendant, he sat on the stand and said if he had known he would not have implanted the mesh in her.  Dr. Luu is no longer a defendant in this case, said Mr. Gage.

If we can’t rely on the ink on the document, our institutions will fail, warned Mr. Gage referring to a signed informed consent agreement.

Mr. Gage appears tightly wound on this day.  He recounts 27 days in court, 12 live witnesses who never brought you evidence on why Abbrevo, when compared to other pelvic mesh, is bad, he recounted. You’ve got to get through informed consent, the smoking (Ms. Perry), the erosion. When it comes to erosion, they had to bring in Dr. Margolis when there was a hole in the testimony.  Ten-thousand dollars a day. Even Ms. Perry and Dr. Luu can’t see eye-to-eye whether they had a risk consultation.  You’ve got to get through all of that, he says, to reach a conclusion for the plaintiffs. And on punitive damages, you’ve got to be kidding, you’ve got to be kidding, repeats Mr. Gage.  Like lady justice with the blindfold on, you have to put the blindfold on, you have to weigh the evidence in the courtroom, not outside the courtroom.

j&j LOGORebuttal – The Last Word Before the Jury

Richard Freese, Freese & Goss

Richard Freese, Freese & Goss

Then there is a break and a rebuttal by Richard Freese who is also incredulous.

Thank you for being here said Mr. Freese. The good news is I’m the last person you will hear from in this trial.  He first shows an exhibit and highlights the first document. A credo from the Johnson & Johnson. Every employee of J&J is commanded to abiding to this credo.

The first sentence, ‘We believe our first responsibility is to doctors, nurses and patients who use our services.’ Please keep that sentence in mind, says Mr. Freese.  Remember Dr. Luu said he did not know it was heavyweight mesh and it was stiff mesh and there was an alternative. I did not know it degraded. If you had known those facts would you use the product? He said no.  That evidence is uncontradicted.

Once it is put in a woman it cannot be removed. If it goes wrong it cannot be removed. The industry did not tell doctors how to get it out.  Nobody told you they ever had any training on how to get the product out. If J&J had provided that information we would not be having this case now, said Mr. Freese. She made the assumption that a reasonable manufacturer could be relied on, that her doctor could be relied on.   I recognize they have experts and we have experts. Freese said Dr. Rosenzweig is not on an island, he was picked by Ethicon to go to Sweden and train with Dr. Ulmsten; he was part of their team. (countering what Mr. Gage had said that Dr. Rosenzweig was on an island somewhere in his singular opinion).

They did not find a single doctor outside of their payroll to come here and defend the product, they bring in their paid consultants.  They did laser cut mesh because it was cheaper and faster. They did not have a single witness tell you laser cut mesh was safe because, said Mr. Freese, it isn’t. Why aren’t the Ethicon engineers here to tell you it’s safer? As to Dr. Flynn, half of his patients are men and he doesn’t even use Abbrevo.   You realize Dr. Flynn is the only doctor in the case who blames her obesity, smoking and her calorie restricted diet had something to do with her wound healing.

For Ms. Perry, her life has been on display. She’s had to be in this courtroom to listen to the most personal details of her life.  While she was here every day at trial, not one person from Ethicon sat and watched this trial, said Mr. Freese. Instead they go after her personally.  Patients are first unless you make us defend the safety of our product, he said referring to the J&J creed. In that case we will attack you and go into your medical records back in time and see whether we can pick out something to pick on you, said Mr. Freese. She must be making it up, he said, and what does that have to do with whether something is negligently designed, he asked. Nothing.

Pain and suffering noneconomic damages

Lawyers have struggled forever – how do you explain noneconomic damages to jurors. How do you put a dollar value on something you can’t see, he asked.  On punitive damages, Mr. Gage said ‘Are you kidding me?’   He asked you to ignore the judges directions which are you must look at their financial condition if you decide to award punitive damages ($70 billion a year).  The judge has said punitive damages are intended to discourage this kind of behavior, said Mr. Freese.  (Mr. Freese is not allowed to mention the number of punitive damages because the defendant did not in its closing.)  Mr. Freese said remember this is a company that did not do a single test on laser-cut TVT Abbrevo. They lied to the FDA and didn’t listen to their own scientists, said Mr. Freese.

If it’s the gold standard to ignore your scientists, and the real world of women’s bodies, don’t tell your sales reps and the FDA the full story; don’t tell doctors the full story. You cannot take a piece of plastic mesh and put it in a woman’s pelvis, you’ can’t do that, he said.  If you believe they didn’t put Ms. Perry first, make them pay for that mistake. Thank you very much, Mr. Freese concluded. #

By | 2015-03-02T16:29:06+00:00 March 2nd, 2015|News|23 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. Jan Urban March 2, 2015 at 5:21 pm - Reply

    Wow….Intense…. What courage and strength Ms. Perry displayed throughout her trial. Thank you and best wishes to you and your husband.

  2. Disgusted March 2, 2015 at 6:03 pm - Reply

    WOW! I am so angry at the defense attorney. How can he not figure out that prolene stitches and the abbrevo are not the same product? He only knows opinions and nothing about the human body. Other lawyers have said this and gotten away with it. I’m tired of seeing one hand tied behinds the plaintiff’s back. No mention that this product has hurt thousands of women. And who knows how many more are out there being lied to and believing the crap that this defense attorney spread out liberally. I’ve faced Dr.’s saying these same things. Liars. As I went through his reasoning all I could say was “that was a lie, oh, here’s another one. Etc.” I pray the jury will see through the drama to the cold hard facts. Fact – Ms. Perry is in pain. Fact – She still has mesh in her body. Fact – it does degrade, fray and migrate (they don’t want us to know that). Fact – it shrinks. Fact – there are so many nerves in a woman’s pelvis and we’re not all mapped the same – when mesh get’s within 1 cm of a nerve it can cause pain. Fact – She will probably have to have more surgeries – to get the mesh out. The defense attorney must have been in error on pore size (did I read it right?) Fact – pore size does make some difference, however all mesh causes erosion. Fact – the studies he referenced were not done independently of a major pharmaceutical. It just makes me sick that it coming down to opinions, instead of truth. Spin – the defense it good at that!

  3. John March 2, 2015 at 6:48 pm - Reply

    Polypropylene mesh implanted devices are PERMANENT implants mr defense lawyer, polypropylene sutures are used to close wounds, whether accidental or intentional, and are designed to be removed. You defense attorneys really need to stop trying to confuse the issue! The jury will not be fooledby this trick but if you believe it yourselves then you are the fools!

  4. Msm March 2, 2015 at 7:04 pm - Reply

    Gage really came off as a pompous a**.

    Freese came off as a champ !

    Just my opinion.

  5. Disgusted March 2, 2015 at 9:28 pm - Reply

    Mr. Gage said “Dr. Grier has been a practicing surgery for 30 years and he relies on Prolene sutures, said Mr. Gage. If they degrade, patients will die!” What a crock, what an idiot. Prolene sutures dissolve. They are not permanent. There is a difference. Let me know if I’m wrong.

  6. Dawn March 2, 2015 at 9:39 pm - Reply

    1000 cases studied ????

    I wish we could get 1000 of us to show up and call ourselves

    The case studied . While wearing shirts that say FAILED

    • Patty March 2, 2015 at 10:10 pm - Reply

      Dawn I’ve been saying all along I’d like to get a caravan of people to go to one of these hearings. The shirt idea is awesome!!

  7. Karen March 3, 2015 at 2:07 am - Reply

    I was wondering if any of our attorneys knew that johnson and Johnson tried to get investors like Texaco/ Chevron Oil Corporation to help them finance transvaginal mesh and was turned down due to lack of tests ?

  8. Lynn March 3, 2015 at 4:53 am - Reply

    I have never posted on here I would first like to say hello to all of you and I am very sorry for all of the other people that are going through this very same thing. I myself have been implanted with a mesh that was manufactured by Ethicon as well I had a federal court trial scheduled,it sounds all too familiar it’s the same story is the patient’s fault the focus is not on the defective product it’s on the individual their past life what they’ve done what they’re doing and what they plan to do, I have been through what I feel is living hell I still have the mesh implanted in me and it is been several years it has obstructed into my digestive track, infected BUT they feel removing it could worsen my overall condition or you have a certain step up to the plate that won’t tell you exactly how successful the removal rate has been for him and removing the mesh which immediately puts the brakes on for me!It makes no sense to me why all of us have to defend ourselves against something that we clearly had no choice and I was not warned of any problems with the product I was told it was the safe and my recovery would be a breeze and none of that was true now I sit in the position where My attorney withdrew and his grounds or he couldn’t prove that the mesh was causing my problems yet I have heard lie after lie from doctors and attorneys I’ve lost most my faith in the system And I ponder quite often why I feel as though I am a criminal of sort defending myself yet I’ve done nothing but said yes to something I thought potentially correct a hernia as I had never had one in my life before I have the proceed mesh it is not the TVT yet it is The exact same material with the exact same defects. I can’t seem to find another attorney to secure my case as they have made it to where I have to file in my state and my state only. What I truly can’t come to grips with understanding is we’re human beings were not famous matter fact most of us have lost the quality of life that we will never regain again and and thinking the way I think today I feel so depressed and so betrayed because they’re not being made to stand up for what they have done and enough is enough!! I’m wondering if this will turn around and I will find legal counselwithin my timeframe in truth I did not ask to pass away when I agreed to the implant but essentially that will be the end result after it has obstructed my vital organs and continues toit has migrated and failed completely it’s serving no purpose but absolute damage why is this our fault why is this my fault there’s so many criminals in prison for murder yet this is just looked over as if it’s not murder and that is absurd when you knowingly put a products on the market that it could potentially hurt people and the effects of it which they were warned of other medical advisor what is it called??? They are defending themselves against hurting people they Became richer and richer as we became sicker and sicker and many have already passed away The rest of us are hanging on to every last good moment if and when we have them and pondering what tomorrow will bring and to keep the strength to go and then to have to fight for justice this is what they want essentially stress willcause more damage to Body as a whole and that’s what they want! The longer they can run these trials and they can stress of the plaintiffs the quicker we will pass unfortunately then we don’t matter we don’t exist they continue to living their normal lives with their healthy bodies and they go to bed every night with not to worry with not a care was not one shred of remorse I see it in The eyes of the attorneys that are representing them there has got to be a way to get every judge and every federal court and state to recognize that this is not about who we are as individuals what we’ve done in our past whether we smoke what our favorite food is this is about a company that Is making every effort to wear each and everyone of us out that is in the system up against them and it’s really sad that they let this go on I just know the Lord does not like greed I don’t mean to Bible thumper but in truth the Lord will prevail and they will have to answer in the end.

  9. Lynn March 3, 2015 at 5:29 am - Reply

    We as human beings aren’t suppose to act in this manner, it becomes national news when it comes to civil rights ect and I feel I am dying a little every day as anyone that is going thru what we are knows the pain and the complete loss of our own bodies as a whole it is horrible and quite frankly very scary…YET KNOW ONE HEARS ME (us) my tears I cry the uncertainty of knowing how long my body will fight and pray for time to get revision surgery knowing the risks and finding that surgeon that cares and one I trust to put my life in his hands again this is the absolute hardest daily cycle of a nonproductive mentally and physical confusing life. I’m actually scared to bond with my grandchildren because I wanna spare them the pain of the loss that will come if I pass…it ripes my heart out everyday I’ve never done anything so cruel in my life that I ever deserved this and I am broken. Help us please!!!!!!

  10. Karen March 3, 2015 at 1:56 pm - Reply

    AMEN LYNN! You are so right , and like you said God don’t sleep and these transvaginal mesh corporation will get their just do right now today and everyday , This is UNGODLY !!!!!!!

  11. David March 3, 2015 at 4:38 pm - Reply

    With regards to Mr. Gage’s comparison of “a single strand of suture to a woven mesh implant made up of many strands”…and then his “grasp” at a rationale for the historical use of sutures –to also, subsequently, have the ability to transfer its safety and effectiveness understanding onto mesh too…problematic to a portrayal of coherent logic was the failure to have differentiated “same intended use”. This failure to differentiate intended use was the gross failure to have comprehended “how [prolene use could be…] safe for a suture and not the Abbrevo [mesh]”. And, upon addressing this “see no evil” understanding failure (with Dr. Heniford’s following logic bound rationale), it would, thereby then make the same material mesh device unfit for its intended use (as currently used in clinical practice and labeled).

    Todd Heniford, M.D. (formed American Hernia Society President) stated in the Ethicon/ Johnson & Johnson DVD, The Benefits of Lightweight Meshes In Ventral Hernia Repair: “Every foreign body develops an inflammatory response, and the more foreign body, the greater the inflammatory response, typically.” — What is the difference between a suture line measured in inches (and then perhaps incrementally in feet) and a football field of the same foreign body measured in compounding yards, if not, as Dr. Heniford clearly understood: a “greater […] inflammatory response”? And, with a foreign body’s (a mesh’s) in vivo time in the human body (in particular), Dr. Heniford found: “when you start to study meshes like this [‘heavy weight polypropylene mesh’ = a ‘foreign body’ too like prolene mesh…] what you see is that the meshes become oxidized. They shrink, they become more brittle.” “…All of these meshes shrank because of their [the mesh’s] inflammatory response, and the more inflammation, the more contraction of the mesh, more contraction of the wound that we see, the meshes becomes stiffer.”

    – What is the difference then between the intended use of sutures comparative to a mesh device, as it would relate to the fitness of a shared intent use and contraction of same base materials? From my layman’s perspective, I would think that the non-inertness of a surgical mesh device would be the issue making it unfit for its intended use (unlike sutures) due to the volume of material, as “more foreign body” = “the greater the inflammatory response”. And, while with “more contraction of the wound […] the meshes becomes stiffer,” it can also be logically discerned that upon contraction of sutures – with “more contraction of the wound” – contraction would be more isolated into the suture line then tension placed onto surrounding tissue, supporting structures and the nerve in-growth into mesh pores/scar tissue plane surrounding the highly inflammatory mesh device (when compared to sutures). A mesh repair is only “tension free” at the time of the repair!

    – What is the difference then between the intended use of sutures comparative to a mesh device, as it would relate to the fitness of their “same intent use” and degradation of shared like base materials? Also from my layman’s perspective, I would think that if sutures can be removed…when the tissue has mended, Dr. Grier is incorrect when he stated: “if [sutures] degrade, patients will die!” He appears to be both very shortsighted and one-sided in his perspective, for the lifelong material complication risk, subjected to patients, which follows a surgical mesh device’s permanent implantation.

    – What would the reasonably foreseeable, catastrophic failure of surgical mesh look like in the human body? To again quote Dr. Heniford from the above mentioned DVD: “This is a mesh tumor, and you can see what it looks like on the back table, how hard this mesh is, and you can picture why you can feel this mesh with essentially every abdominal movement. As a surgeon, if I fix a hernia with a heavy weight polypropylene mesh, and do not have recurrence, but the patient is able to feel that mesh for the rest of their life, the next 20, 30, 40, 50 years, then have I really done something for that patient long-term?”…(The “what should come first question” answered: patient effectiveness comes before surgeon efficacy –mesh risk outweighs benefit in a gold standard of care)…“The inflammation never goes away. There is never a decrease in the inflammation around the heavy weight meshes, and the meshes become very brittle, very firm, and it is, unfortunately, a lasting problem for the rest of the patient’s life….”… “You see this [inflammation] at a week, you see this at four months, and you see this sitting here. And actually information statistically never changes. This mesh is chronically and constantly under attack.”

    – What effect would the migration of “a mesh tumor” have in the human body if not the very foreseeable patient injuries resulting from its erosion into surrounding tissue and supporting structures?

    …Is it even possible that Mr. Gage can logically even compare “a single strand of suture to a woven mesh implant made up of many strands”? The former “comparison” in my opinion, would be akin to trying to “splitting a hair” between ingesting a gallon of gasoline and implanting one single polypropylene (petroleum based byproduct) resin pellet into the human body. (This would be due to the fact that the less foreign body = the less the inflammatory response caused by that foreign body.)

    • David March 3, 2015 at 4:47 pm - Reply

      Should have written in the last paragraph: …would be akin to trying to “split a hair”…As the difference between a gallon of gasoline and one single polypropylene resin pellet in not really logically applicable to the risk from the “same intended use”.

    • abandoned March 3, 2015 at 5:24 pm - Reply

      I may not be reading the case testimony right….But if I am, then someone needs to define the difference between a small strand of one Vycril #2 suture strand dissolving vs. mesh deterioration! For me personally, it seems that defense is saying dissolving is good in suture materials, however, there is no evidence that PPmesh deteriorates.

      The smaller the cut, the smaller the scar….right?

      • David March 3, 2015 at 7:57 pm - Reply

        To be clear, I have not read the case testimony, only Jane’s reporting on the trial. So I am not exactly sure the reason for why “Mr. Gage said he’s having trouble understanding the theory that Prolene degrades.” For me also, as you say, a “difference between a small strand of one Vycril #2 suture strand dissolving vs. mesh deterioration” would seem problematic to “saying dissolving is good in suture materials” when (upon accepting that reality) then apparently contradictory claiming (at the same time) that “there is no evidence that PPmesh deteriorates”. (And, even more so because Dr. Grier believes that “if [sutures] degrade, patients will die!”)….But even more problematic for Mr. Gage, was upon saying that he could trace the 510(k) predicate chain back to look for Abbrevo’s safety and effectiveness…was when also claiming he found Abbrevo’s safety and effectiveness, which I believe is not even possible.*

        * The three main reasons why a reasonable assurance of safety and effectiveness “…cannot co-exist with the long successful history of…” “substantially equivalent” (“SE”), 510(k) predicate device clearances down a “SE” Prolene mesh device’s family’s lineage is 1) due to the lack of effective post-market surveillance, 2) the irrelevance of that post-market surveillance to prevent a past “SE” device’s market clearance and 3) the failure of “SE” to have anything to do with the safety and effectiveness of either a past and future FDA found “SE” device’s 510(k) clearance. Plain and simple: One cleared device (the past or next “SE” “predicate device”) is no less dangerous then a comparative “SE” device because neither device was FDA approved for a safety and effectiveness understanding. And if approved – it would not have been cleared…and then there might be a reasonable assurance of safety and effectiveness – otherwise “SE” if not.

        “The smaller the cut, the smaller the scar” is not necessity true. To quote (for credibility sake) C.R. Bard, Inc., from a February 24, 2010 letter they sent to me, “[the scar tissue] is the mechanism by which the body seals the hernia.” “[It] is a known response of the body to the mesh.” Therefore, there is both the external visible scar (to support “the smaller the cut, the smaller the scar” rationale) and the internal, intended scarification “…response of the [human] body to the mesh”. “However…” as C.R. Bard, Inc. went on to problematically write to me in their February 2010 letter, to contradict, in my opinion, the historical safety and effectiveness of any synthetic surgical mesh in any patient’s body, “…patient responses can differ somewhat, and in unpredictable ways – some people develop exuberant scar responses and others very little response.”**

        ** This is particularly troubling for their Bard 3DMax Mesh device in particular (the topic of their letter) and for me particularly by personal experience, when implanted with two of these device–with the same resulting injurious outcomes, since they market their 3DMax device to purportedly not require any fixation…other than the human body’s scarification response…but, as they wrote to me, this intended response is “unpredictable” because they cannot predicate the in vivo performance of their “SE” mesh device in a patient’s body.

        Just my opinion too…but I think Mr. Gage might what to “reality check” his rationale with C.R. Bard, Inc.’s inability to predict the patient’s response following the permanent implantation of a same material surgical mesh device. He might find that a “SE” device’s 510(k) predicate device lineage’s subsequent lack of a reasonably safe or effective would also make Abbrevo’s use of “SE” Prolene mesh unfit for its intended use too. There comes a point when the sky must be accepted, on a sunny day, to be blue.

  12. Jane Akre March 3, 2015 at 8:50 pm - Reply

    Late word on the Perry Trial from a courtroom insider – Since the jury is on it’s second day of deliberations they have asked to hear or have read back to them portions of various testimony. This was a very long trial, I am sure they are having to go back and refresh their memories a bit. There is something to be said for a the faster trials of Judge Goodwin.

    • Ronald James March 4, 2015 at 3:37 pm - Reply

      Jane, I’m trying to find the court dates here in Charleston, wv. Do you by chance know when they are scheduled? I really want to hear the testimony so I can keep my mother informed.

      • Jane Akre March 4, 2015 at 4:36 pm - Reply

        Ronald, the Bellew case is underway now and I cannot be there. Can you go? I would appreciate it. It should last for two weeks… the plaintiffs put on their case first which will last until approximately next Tuesday.. Then defense presents their case. Should be concluded by the 13th perhaps. You will not regret going. Watching the proceedings is amazing and revealing.

        • Ronald James March 4, 2015 at 4:51 pm - Reply

          Jane, I will be there tomorrow if they don’t shut down because of the predicted snow storm. I will let you know what I hear and see. 🙂

          • kitty March 4, 2015 at 6:18 pm

            Thank you James.

  13. Disgusted March 5, 2015 at 8:42 am - Reply

    Prolene is a synthetic, monofilament, nonabsorbable polypropylene suture. It is indicated for skin closure and general soft tissue approximation and ligation. Its advantages include minimal tissue reactivity and durability. Disadvantages include fragility, high plasticity, high expense, and difficulty of use compared to standard nylon sutures.

    I wish the jury was given this definition of what prolene really is.

    • David March 5, 2015 at 4:48 pm - Reply

      On Ethicon’s website it states: “PROLENE® Polypropylene Mesh” is “constructed of the same knitted polypropylene monofilament as PROLENE® Polypropylene Suture….”

      On Wikipedia it states: “A polypropylene mesh is also marketed under the name Prolene by Ethicon.” “The name Prolene is a trademark of Ethicon Inc.”

      As “PROLENE® Polypropylene Mesh” is made out of “the same knitted polypropylene monofilament as PROLENE® Polypropylene Suture,” I now think (as I failed to do consistently in previous posts), Prolene mesh/sutures should always be capitalized to account for their shared base polypropylene materials. Because if you don’t distinguish between Prolene mesh or Prolene sutures – by failing to capitalize Prolene – when using it alone (to account for Ethicon’s trademark), it applies that the base material is prolene (regardless if you understand that Prolene mesh is “constructed of the same knitted polypropylene monofilament as PROLENE® Polypropylene Suture…”).

      Even more confusing, however, on Ethicon’s website under “PROLENE® Soft Polypropylene Mesh,” it states PROLENE® Soft Polypropylene Mesh’s “unique design results in a mesh that is approximately 50% more flexible than standard PROLENE® Polypropylene Mesh.” It is interesting that “PROLENE® Soft Polypropylene Mesh” could be “approximately 50% more flexible than standard PROLENE® Polypropylene Mesh,” and also then, still be understood to be a “PROLENE®” mesh and not a different polypropylene mesh altogether (via its “unique design” consideration).

      If Ethicon is changing device design “[flexibility]”, to make “PROLENE® Soft Polypropylene Mesh” out of the same “PROLENE® mesh,” how could they even then have compare the in vivo performance of a Prolene polypropylene mesh device and Prolene polypropylene sutures as the same? With a “night and day” change between sutures and a mesh device: Prolene sutures could remain fit for their intended use, while the same polypropylene (Prolene) used in the design of a “substantially equivalent” Prolene mesh device, like for example, the Abbrevo mini-sling, would – as was in the case of Perry v. Ethicon – make it “defective in its design and in its instructions to doctors, [and for] the end users”….and, consequently, unfit for its “same intended use”.

  14. PLC March 5, 2015 at 12:17 pm - Reply

    Starting to get a little nervous about the jury’s decision

    Hopefully what ever it is taking so long is just them trying

    to decide if J&J knew about the dangers and jury is deciding

    how much in punitive damages should be awarded as well.

    Fingers crossed

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