Ethicon 7/1

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Online Sources

1. MYTH BUSTERS- What Women Are Told Today About Pelvic Mesh

   Jun 30, 2016 | Mesh Medical Device News Desk

   One of the problems with pelvic mesh, and there are many, is that patients never receive true informed consent. What would informed consent look like?
2. MYTH BUSTERS Part Two – What Women Are Told Today About Pelvic Mesh

   Jun 30, 2016 | Mesh Medical Device News Desk

   This is often heard from Canadian doctors who want to isolate this as a U.S. problem or from docs who want to blame the problem on an antiquated mesh.
3. MYTH BUSTERS- Part Three – What Women Are Told Today About Pelvic Mesh

   Jun 30, 2016 | Mesh Medical Device News Desk

   ‘Don’t worry, if there is a complication we can take the “tape” out,’ has been heard by many women who are being sold on a pelvic mesh implant.

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Online Sources

1. MYTH BUSTERS- What Women Are Told Today About Pelvic Mesh

   Jun 30, 2016 | Mesh Medical Device News Desk

   One of the problems with pelvic mesh, and there are many, is that patients never receive true informed consent.  What would informed consent look like?

   Your doctor may say, this mesh is made of polypropylene, a polymer plastic, we anchor deep into your body. It can’t come out. We have no idea which individuals will have complications which that may include pelvic and chronic pain, ongoing infections, dyspareunia or painful sex, nerve damage, a return of incontinence or prolapse.  We don’t know if you will be one that falls into the 30% complication rate.  You will likely need additional surgery or surgeries to correct the problems or to remove the mesh.

   How does that sound?  Ready to schedule your appointment for surgery?  In case you need more convincing, just catch a YouTube video of the procedure. That is more than most people can take.So what ARE doctors saying to patients?

   We’ve heard many things from women newly implanted with pelvic mesh of them are untrue. So if you have been told you need surgery to treat stress urinary incontinence (SUI) or pelvic organ prolapse (POP) and mesh is the answer, let’s bust some of the myths circulating about the procedures.

   Myth #1- Don’t Worry- Pelvic Mesh is a lot of Lawyer Hype 

   To presume this is true would be to believe that more than 100,000 women in the U.S. have filed lawsuits because their lawyers are looking for a legal “payday” and the women are unwitting pawns in the scheme.  Really?  How disparaging of women and the legal profession.  Fact: The women have filed lawsuits because there is indisputable evidence that the mesh manufacturers – Boston Scientific, Johnson & Johnson, AMS, CR Bard and the others – knew in advance that their mesh would have problems and they did nothing to stop the fast-track train to marketing. They trained anyone and everyone with an MD after their name who was looking for a payday – a greater return on medical procedures.  At trials, doctors have admitted they were expecting a huge jump in income by using pelvic mesh implants that everyone else was using.  Even the FDA is on record saying that pelvic mesh complications are “not rare” so shame on those doctors who are blaming lawyers and women.

   Myth #2 – That Mesh Has Been Recalled
   

   The Fact: Few meshes have been recalled although a few have been quietly removed from the market for “business reasons,” according to the manufacturer.   The ProteGen sling, made by Boston Scientific, is an exception. Introduced in 1996, three years later, ProteGen was recalled because of “a higher than expected rate of vaginal erosion and dehiscence, and does not appear to function as intended.”  In other words, defective.

   But removal from the market does not mean forgotten. To market a new medical device one needs to name a predicate and ProteGen is the predicate for at least 60 other meshes that were marketed after it. Sort of like saying our car is similar to the exploding Pinto, but don’t worry! BTW- There is no mechanism within the FDA to review meshes based on a defective predicate.

   In January 2012, after the FDA required manufactures to do postmarket surveillance studies, some mesh makers quietly removed theirs from the market.  Gynecare Prolift Kit and ProliftM+ by Ethicon (Johnson & Johnson) Gynecare Prosima and Gynecare TVT Secur. The Ethicon/Gynecare/Johnson & Johnson pelvic meshes quietly went away but were not formally recalled.

    

   Myth #3- Pelvic mesh is FDA approved!
   

   This is scary and untrue. Fact: The FDA does not approve mesh based on safety or efficacy.  The FDA approves most medical devices for sale. Classified as Class II or moderate risk, the permanent implant is not required to undergo clinical trials (human testing) which would most likely have shown the complications such as mesh erosion, infection, mesh shrinkage, nerve entrapment, etc.  The FDA’s own 510(k) approval process allows manufacturers to take the “least burdensome” route to approval, regardless of the fact that the “burden” then rests on the poor patient who discoverers after the fact that their device was marketed based on assurances from the manufacturer who has the most to gain by its marketing.

   http://www.meshmedicaldevicenewsdesk.com/myth-busters-women-told-today-pelvic-mesh/
   

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2. MYTH BUSTERS Part Two – What Women Are Told Today About Pelvic Mesh

   Jun 30, 2016 | Mesh Medical Device News Desk

   Myth #4 – We Don’t Use ‘That Mesh’

   This is often heard from Canadian doctors who want to isolate this as a U.S. problem or from docs who want to blame the problem on an antiquated mesh.  Fact:  “That mesh”   is polypropylene mesh. That is the number one question to ask if you hear the above – “Is it polypropylene?”  If the answer is yes, that may be your cue to find the nearest exit. The fact is that unless a mesh has been quietly removed from the market, and there are a few of them, the problematic mesh is still used every day. That includes pelvic meshes that have been found to be defective in a court of law.  Incredible! They are still for sale.  Did your doctor tell you that?

   “Mrs. Jones, this mesh has been found to be defectively designed by a jury after listening to evidence in a product liability trial, but I’m sure it will be fine.”  Not.  Look at the label, that’s all you need to know.

   Myth #5 – It’s Not Possible that Your Mesh is Causing Your Pain

   You got to love this one. You didn’t have pelvic pain before mesh, then you have mesh and are in excruciating pain. The doctor says it couldn’t be the mesh.  It’s been placed correctly. Fact: Until recently, studies did not even consider QOL (Quality of Life) as a factor to define the “success” of a mesh placement. Anatomical placement, in other words, mesh in the correct place defined a “successful” outcome.

   Never mind that the woman may be unable to leave her bed because of the complications, much less work or care for children.  Women were told if the mesh was in the correct place, it couldn’t be presenting you with a problem.  You might want to see a counselor, a psychiatrist or we could send you to pain management.  Countless women have heard the above.

    

   Myth #6 – Mesh has been used for 50 years without problems

   Fact:  This statement has been repeated to women by doctors wanting to implant pelvic mesh and by the defense lawyers for manufacturers – Boston Scientific, Ethicon (Johnson & Johnson) and CR Bard at trial.  The issue is the quantity of the mesh.  That defense attorney is referring to polypropylene sutures which have been used since the 1970’s for hernia repair.  Since pelvic organ prolapse was thought to be a hernia-like condition, sutures knitted into a mesh, some as large as a hand, with extended arms, were developed. Of course the quantity of the mesh for a small suture repair and a large mesh implant is not comparable. As one mesh critic doctor says, “The more mesh, the more mess.”

   Unfortunately, the FDA has not issued any warning about the rate of complications for hernia mesh, though many suffer the same symptoms as pelvic mesh women. 

   http://www.meshmedicaldevicenewsdesk.com/myth-busters-part-two-women-told-today-pelvic-mesh/
   

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3. MYTH BUSTERS- Part Three – What Women Are Told Today About Pelvic Mesh

   Jun 30, 2016 | Mesh Medical Device News Desk

   Myth #7- We can take it out if there’s a problem

   ‘Don’t worry, if there is a complication we can take the “tape” out,’ has been heard by many women who are being sold on a pelvic mesh implant.  This is a dangerous myth. Fact:  Mesh is intended to be a permanently implanted medical device. Whether to treat incontinence, prolapse or a hernia, mesh is not intended to be removed. Ever.  In time, it incorporates with the body. A removal or explant has been likened to removing gum from hair. There are a few experienced surgeons who specialize in mesh removal but a total removal is nearly impossible. Fragments are always left behind as are the anchors, deeply placed in muscle and ligament. Scar tissue results from an aggressive removal, which has been shown to cause mesh to shrink and encapsulate nerves.  Experiencing severe, unrelenting pain after an implant indicates a mesh removal should be attempted, according to expert surgeons.

    

   Myth #8 – Only Bad Doctors Have Complications

   This defies logic.  Are there 100,000 bad doctors in the U.S. implanting mesh? Medical societies have convinced their membership that a few “bad apples” are responsible for mesh injuries. ‘YOU would never have a problem.’ Fact: Many implanting doctors were trained during weekend cadaver clinics. Others have sales reps in the room during surgery directing the procedure, sales reps who are not surgeons or even doctors.  And if manufacturers know there are inexperienced doctors placing mesh, why do they continue to sell to them?

    

   Myth #9 – The Problem is With Prolapse Mesh not Slings

   Manufacturers and their consultant doctors have learned to call pelvic mesh “tape” or “slings” to soft sell it.  Fact: It’s still a polypropylene mesh even though a “tape” or a “sling” is a smaller piece of plastic mesh used in the treatment of stress urinary incontinence (SUI).  The truth is the courts have more lawsuits lodged against SUI mesh, both TVT and TVT-O, than against the larger mesh for pelvic organ prolapse (POP).  TVT-O has been found to be defective by a number of juries who have listened to the evidence. The U.S. Food and Drug Administration has ordered POP mesh manufacturers to show their products are safe and effective before they are reclassified as “high-risk” or Class III by the FDA in  two years.  This applies only to POP mesh and not the TVT and TVT-O used to treat incontinence. That remains Class II or a “moderate risk.” It is still implanted every day.

   
   

   Myth #10 – Don’t Read the Internet

   The internet is fast becoming the outlet for all credible and established publishers. Fact: Today most people get their news online!  That includes medical news and especially news regarding medical devices and pelvic mesh. There are awesome communities of injured who have come forward on the web to share their stories, the names of their bad doctors and most importantly, to help others with any remedies or doctors who have improved their life after suffering complications from pelvic mesh.  The communities of women, men and families are tweeting, posting on Facebook and reading the gathering places like Mesh News Desk to catch the latest news, legal developments and the emerging medical and science on mesh.  We only wish more doctors would read the internet.  #

   http://www.meshmedicaldevicenewsdesk.com/myth-busters-women-told-today-pelvic-mesh-2/
   

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