Four J&J Vaginal Meshes Named – Will Be Removed from Market

Jun 5th, 2012 | By | Category: Feature

June 5, 2012 ~ There is now more detailed information about the move by Johnson & Johnson (J&J) to stop the sale of four vaginal mesh implants.

The four named meshes are:

TVT Secur

Prosima Pelvic Floor Repair System

Prolift Pelvic Floor Repair System  

Prolift MTM Pelvic Floor Repair System

These are the four vaginal mesh implants named in a pair of letters that were sent to the federal judge who is overseeing the multidistrict litigation in Charleston, West Virginia and the state court judge overseeing litigation in Atlantic City, New Jersey.

Thousands of cases have been filed by women against 9 mesh manufacturers, Johnson & Johnson’s Ethicon division among them, who claim the products cause complications that include mesh erosion into the vagina and organs, pelvic and nerve pain, infection, mesh migration, a return of incontinence and prolapse, and in some cases death.

Ethicon has no present intention to commercialize these products in the future, but it has requested that FDA allow it 120 days to cease commercialization. This time period would permit Ethicon to notify its customers, and provide those hospitals and surgeons with sufficient time to select alternative treatment options for their patients,” the J&J unit wrote the judges as published by Pharmalot.

Ethicon will also discontinue or revise, as appropriate, all marketing materials during this time. Ethicon will continue to report adverse events and provide medical communications for these products, consistent with applicable regulations; however, Ethicon has requested that FDA’s Office of Surveillance and Biometrics place the existing 522 orders requiring additional studies for these products on hold. Ethicon is awaiting written confirmation of that plan.”

J&J will update the product label for the Gynecare Gynemesh PS to further restrict its use for abdominal sacrocolpopexy procedure.  The company has requested sales be allowed to continue of the Gynecare Gynemesh PS while a label change is underway.

J & J still has not followed through on an FDA order issued last January for it and 30 other mesh manufacturers to conduct post-market studies on organ damage among the women already implanted with vaginal mesh. (Background story here).

The Prolift has been in the news lately. Recall that it was put on the market in 2005 without any regulatory okay from the FDA. The FDA only caught on when J & J went to get the approval for a similar mesh and named it as a predicate. The FDA went ahead and approved both meshes in May 2008.

An Ethicon spokesman tells Ed Silverman’s Pharmalot that “this is not a product recall. We continue to have confidence in the safety and efficacy of these products. Our decision to discontinue these products is based on their commercial viability in light of changing market dynamics, and is not related to safety or efficacy.”

The company plans to phase out the products over the next 12 months.

This is just the latest in a long line of defective product recalls for the pharmaceutical and medical device giant. J&J has seen recalls of over-the-counter cold products, hip replacement devices, epilepsy drugs, contact lenses, not to mention eroding consumer confidence.

What’s Next

The outstanding question now is how many of the other manufacturers will follow suit and give up the marketing of lucrative medical devices for female pelvic health.  With thousands of lawsuits amassing in West Virginia and New Jersey, no doubt lawyers will use the withdrawal to their advantage to argue the company knew all along it has a product liability problem yet sold the devices anyway.

And the FDA’s controversial 510(k) approval product is now front and center. With no requirements for safety and efficacy, 510(k) allows a medical device, even those moderate to high-risk, to be placed on the market with an exchange of paperwork.

The Institute of Medicine last year said that 510(k) was ‘fatally flawed’ and should be abolished. In a report by the US Government Accountability Office last year, the FDA was slammed for a failure to recall products and regulate high-risk devices approved under 510(k).

It is the same approval process that has allow metal-on-metal hips be marketed and defibrillator leads, both defective which are later found defective when they injured unsuspecting patients.

 

Learn More:

Ethicon letter to federal court judge, June 4, 2012:
http://freepdfhosting.com/012ad47703.pdf

Ethicon letter to state court judge, June 4, 2012:
http://freepdfhosting.com/df4764c7d4.pdf

FDA January 2012- 522 studies ordered
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm

GAO, June 2009 – Medical Devices, Shortcomings in FDA’s Premarket Review, Postmarket Surveillance, and Inspections of Device Manufacturing Establishments
http://www.gao.gov/new.items/d09370t.pdf

Ethicon Gynecare products
http://www.ethicon360.com/products/ethicon-womens-health-urology

MDND, March 21, J&J Sold Vaginal Mesh Implant Without FDA Approval
http://meshmedicaldevicenewsdesk.com/media-reports/breaking-news-j-j-sold-vaginal-mesh-implant-without-fda-approval/

MDND, August 21, 2011, Study Halted Due to Mesh Complications
http://meshmedicaldevicenewsdesk.com/featured-articles/study-halted-due-to-mesh-complications/

MDND- Mesh Makers Who Received 522 orders
http://meshmedicaldevicenewsdesk.com/fda-notices/mesh-makers-who-received-fda-letter-requiring-follow-up-tests/

 

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12 Comments to “Four J&J Vaginal Meshes Named – Will Be Removed from Market”

  1. Gerold Link says:

    It’s regrettable indeed that the best mesh will disappear from the market. Additionally it concerns the mesh being best evaluated in well done scientific studies. I recently switched to the proloft +M for these reasons. The situation in Europe is very different from the USA may be because of more strict handling of correct indication. It would be desirable if a sale of this product in Europe will be taken into consideration.

    Sincerely yours

    Dr. Gerold Link
    University Medical Center Maastricht, The Netherlands
    Urogynaecologist

    • Jane Akre says:

      Just curious doctor, why do you call it the best mesh?

    • Caitlyn says:

      Sorry, Dr Link, doctors everywhere need to see the writing on the wall. This move by J&J to remove meshes from the market hopefully signifies the death knell for mesh and doctors need to start finding more reliable and less risky ways of treating pelvic organ prolapse and stress incontinence. Plastic mesh is not safe – we don’t need medical degrees to recognise that this stuff does not belong inside the human body. There’s enough evidence out there to show that mesh causes harm. It’s a shame doctors fell for all the marketing tactics from these big companies.

    • Ruth says:

      Dr. Link, please try to understand the devastation and unbearable pain and suffering that any mesh can cause when complications arise. Please read the stories on this site and others, about people whose lives have been destroyed by these products. Unless you have experienced it, there is no way to understand the agony that injured women experience, and as an injured victim I am at a loss to describe it–like my body is on fire. It is unlike any other pain that I have experienced, though I have given birth naturally to 5 children, and survived many tropical diseases. Many women describe it as a “torture device” and I concur. This is happening all over the world, and the situation is no different in your own country, as evidenced by the existence of a support group for injured women in the Netherlands http://www.meshedup.eu/
      Scientific studies focus almost exclusively on whether or not the original problem was surgically corrected, and most fail to take into account serious quality of life issues for the patients.

      • Caitlyn says:

        I agree. There are women who would be considered “successful” in most of the studies because they are ‘dry’ but who are nonetheless experiencing complications – it’s all down to how you measure outcomes. Unfortunately, most of the studies focus on efficacy of the product rather than its safety. If doctors read the numerous stories on internet sites of women experiencing pain, infections and voiding difficulties then perhaps they would start to realise the effect this mesh is having on people.

  2. top_bard@hotmail.com says:

    Best mesh? That must mean there is inferior mesh being used in procedures.
    Handling of mesh medical devices should have been unified worldwide, tested, monitored, evaluated and outcomes recorded.
    From the onset if that procedure had been put in place I and many thousands of seriously injured individuals might have been spared the nightmare of mesh complications. Best mesh I believe there is no such thing exists.

  3. I have lived through ten years of Agony because of a Surgical Mesh Implant for POP repair made by Ethicon. My family and I can tell you that these devices are instruments of TORTURE!! If you can imagine a piece of barbed wire slicing through your innards and slowly scraping its way down through the pelvis stabbing into your bowel and bladder, wrapping itself around the bowel and glueing together your ureters,bowel, bladder, top of vagina and finally scraping and slicing its way out through the vaginal wall- not once, but THREE TIMES!! The fact that my entire pelvis felt as though it had been ROASTED over a slow-burning fire…inability to defacate or urinate properly and all the agonising pain involved.The lack of intimacy with your partner. … The humiliating tests you undergo only to be told that NOTHING can be seen because Mesh cannot be detected by MRI scan- so you are sent away IN AGONY!!! …You cannot walk or drive properly and then after the Mesh finally perforates your vagina or your bladder or your bowel…operation after operation to try and improve your quality of life because by this time IT IS NIL…YOU … The real YOU… has CEASED TO EXIST …you may be lucky in the end and find a way back, but only if you are VERY LUCKY!… If you live in America or Canada you are unable to find help because your medical insurance does not cover the Medical Fees and Ethicon and J&J have denied susceptible patients a duty of care.

  4. David says:

    It all comes down to profit….Profit for the doctors and profit for the makers. Women do not matter in these decisions made by greed. The doctor above states BEST MESH…..Wonder if he would put Best Mesh in his wife or daughter?

  5. [...] Johnson & Johnson removed their pelvic floor mesh from the market, several makers still have theirs readily available for doctors to opt for the “quick [...]

  6. Linda Dodson says:

    Dr. Link,

    You state, “The situation in Europe is very different from the USA.” The situation in Europe with mesh complications is no different than the situation in the USA. MESH used in the pelvic floor area should be banned! It is not safe and it’s certainly not effective…..

    How is the “prolift+M” working for your patients? I doubt that it’s any different than the other mesh kits that the manufacturer’s and their sales representatives are touting in your office. It’s all for the GREED of money and at the expense of innocent women.

    If you truly care about your patients and their outcomes, you would work within the government that oversees your medical devices to ban these mesh medical devices.

  7. Jan says:

    I had Gynemesh PS implanted in February 2012 and suffered intense pain immediately afterwards. Within weeks the mesh was eroding into my vagina and the prolapses returned also.

    In August 2012 I had surgery to trim the mesh and within another couple of weeks it was coming through again. I went into hospital in April 2013 to have the mesh totally removed but the surgeon was unable to access it without causing more damage so it was simply trimmed again, prolapses repaired and hysterectomy done.

    Six weeks later the mesh is eroding even more within my vagina. I am at my wits end. I have not worked during all this time, have great difficulty sleeping and in pain 24 hours a day. My marriage is suffering and I don’t know where to turn. Here in the UK there is very little publicity and doctors are ill informed of the problem.

    My heart goes out to all fellow mesh sufferers who like me have had their lives ruined through arrogance, ignorance and greed.

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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.