June 5, 2012 | 9:13 AM |

Report: J&J To Stop Selling Controversial Vaginal Mesh Implants

FILED UNDER: Medicine/Science, Personal Health, medical devices, prolapse, vaginal mesh, women's health

Pharmalot reports that drug maker Johnson & Johnson will halt sales of several vaginal mesh implants that have been the subject of lawsuits in which women charge that the devices led to painful and debilitating long-term complications. Ed Silverman writes:

In an unexpected move, Johnson & Johnson’s Ethicon unit will halt marketing of four vaginal mesh implants that have been the subject of lawsuits filed by approximately 1,000 women who claim the products have caused serious internal injuries. The devices treat incontinence and pelvic organ prolapse in which internal organs slump into the vagina.
The decision involves four Gynecare products – TVT Secur; Prosima Pelvic Floor Repair System, Prolift Pelvic Floor Repair System and the Proflit MTM Pelvic Floor Repair System – and was disclosed in a pair of letters sent late Monday to judges overseeing different batches of lawsuits – a federal judge presiding over multi-district litigation in federal court in West Virginia and a state judge in New Jersey.

“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.

Silverman got hold of J&J’s letters to the judges, which you can read here and here.

We’ve written about the ordeals of mesh victims like Amy Gezon, here.

Last year, Gezon testified before an FDA advisory panel about her experiences with vaginal mesh and told me after the device was implanted: “I was in the most horrendous pain I’ve ever experienced…I finally ended up in the ER after expressing a desire to end my life just to escape the pain. If I knew one-tenth of the information out there in the literature…I would have never consented to this surgery.”

Before the advisory panel hearing, the FDA issued an alert on the serious, ongoing complications associated with mesh and noted that it’s unclear whether the implants for prolapse offer any benefit over traditional surgery.

In early 2012, the FDA asked vaginal mesh manufacturers, including J&J, to conduct safety and effectiveness studies.

In his report, Silverman quotes a company spokesman saying the discontinued marketing of vaginal mesh implants is not a product recall:

An Ethicon spokesman writes to “stress 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.”

Still, J&J has had its share of troubling product snafus recently, including, among others, the mysterious disappearance of o.b. tampons.

About the author

Blogger, CommonHealth Rachel Zimmerman worked as a staff reporter for The Wall Street Journal for 10 years, most recently covering health and medicine out of the paper’s Boston bureau. Rachel has also written for The New York Times, the (now-defunct) Seattle Post-Intelligencer and the alternative newspaper Willamette Week, in Portland, Ore., among other publications. Rachel co-wrote a book about birth, published by Bantam/Random House, and spent 2008 as a Knight Science Journalism Fellow at MIT. Rachel lives in Cambridge with her husband and two daughters. View all posts by Rachel Zimmerman →

  • Grace

    Does anyone know if you have this Transvaginal mesh disolved does it harden in you your body over time?

  • Kadissa1

    These complications are extremely serious. It caused pain and mental anguish for my wife for few years so far and denying her of quality of life. Resulted in a huge hernia and numerous visits to emergency rooms. swelling and fluid build up made her look like 6 months pregnant.  back in 2010 one LAWYER said there is no case period. only if idiots like him did listen then, thousands of women would have avoided all that pain and suffering. Doctors are no better folks, they never listened to any of the complaints and kept saying give it time it will heal.

  • AGSLC

    Wow, I am in disbelief. I hope the other manufacturers, Boston Scientific, Bard, AMS….etc,  of “substantially equivalent” synthetic mesh products for Pelvic Organ Prolapse and Stress Incontinence will follow the bold move of J & J.  Unfortunately surgeons have accepted the indiscriminate use of synthetic mesh as “standard of care”, it will be difficult for most surgeons to acknowledge the inherent flaws of these “mesh kits” for all aging women, as it allows so many to do surgeries they were not otherwise trained to do. I am uncertain if the egos of many of these surgeons can withstand the pain of acknowledging they were wrong or fell prey to the tactics of industry.

    • NonieWideman

      As much as  J&J are trying safe facing tactics, the bottom line is their products  were not tested sufficiently for a long enough period to be proven safe, that being said the other mesh makers should follow suit before more women are harmed and decide to join the lawsuits…patient safety should supersede all motives and posturing as these companies try to absolve themselves of guilt for not putting safety ahead of corporate profits.