Boston Scientific Mesh Off Market
In April 2019, the US Food and Drug Administration ordered Boston Scientific to stop selling Uphold LITE and Xenform because the companies failed to provide reasonable assurance that the products are safe and effective. Both of these products were used for Pelvic Organ Prolapse (POP). The FDA noted a significant increase in the number of reported adverse events associated with the use of surgical mesh for transvaginal repair of POP and reclassified the products from class II (moderate risk) to class III (high risk).
Women who have had transvaginal mesh placed for the surgical repair of POP are advised to continue with annual and other routine check-ups and follow-up care. Women who are satisfied with their surgery and are not having complications or symptoms do not need to take any additional action. Women who experience complications or symptoms, such as persistent vaginal bleeding or discharge, pelvic or groin pain, or pain with sex, should speak with their healthcare provider.
Boston Scientific’s other products for stress urinary incontinence (SUI), also called slings, continue on the market and are being implanted in women.
Transvaginal Mesh Verdicts – Boston Scientific
- 6/192/16: $0 – Sherrer v. Boston Scientific (Solyx & Bard Align) MO
- 10/15: $0 – Martha Carlson v. Boston Scientific (Uphold) NC
- 5/15: $100 million – Deborah Barda v. BSC (Pinnacle, Advantage Fit) DL
- 5/15: Settled – Sanchez v. Boston Scientific (Pinnacle) CA
- 11/14: $6.7+ million – Amal Eghnayem – Boston Scientific (Pinnacle) MDL FL
- 11/14: $6.7+ million – Margarita Dotres – Boston Scientific (Pinnacle) MDL FL
- 11/14: $6.7+ million – Mania Nunez – Boston Scientific (Pinnacle) MDL FL
- 11/14: $6.5+ million – Juana Betancourt – Boston Scientific (Pinnacle) MDL FL
- 11/14: $5.25 million – Jeanie Blankenship – Boston Scientific (Obtryx) MDL
- 11/14: $4.75 million – Chris Wilson – Boston Scientific (Obtryx) MDL
- 11/14: $4.25 million – Carol Campbell – Boston Scientific (Obtryx) MDL
- 11/14: $4.25 million – Jacquelyn Tyree – Boston Scientific (Obtryx) MDL
- 9/14: $73.465 million – Martha Salazar – Boston Scientific (Obtryx) TX
- 8/14: $0 – Maria Cardenas – Boston Scientific (Obtryx) MA
- 7/14: $0 – Diane Albright – Boston Scientific (Pinnacle) MA
In February 2019, the FDA convened an advisory panel to solicit input from experts on how to evaluate the safety and effectiveness of surgical mesh for transvaginal repair of POP. The panel recommended that to support a favorable benefit–risk profile, surgical mesh should be superior to native tissue repair at 36 months and the safety outcomes for surgical mesh should be comparable to native tissue repair.
The FDA agreed with these recommendations, and because the manufacturers did not provide the required data in their PMAs, the FDA declined to approve them.
“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health.
Boston Scientific Responds to FDA’s Decision to Remove Surgical Transvaginal Mesh as Treatment Option for POP
We are deeply disappointed by this decision and believe the inaccessibility of these products will severely limit treatment options for the 50% of women in the U.S. who will suffer from POP during their lives. We have been working with the FDA for many years to develop the clinical evidence necessary to keep these important treatment options available. Unfortunately, today’s announcement by the FDA removes that possibility for the foreseeable future.
In light of the FDA’s decision and ongoing discussions with regulators outside of the U.S., Boston Scientific will stop global sales of its transvaginal mesh products indicated for pelvic organ prolapse: Uphold™ LITE Vaginal Support System, Xenform™ Soft Tissue Repair Matrix, Pinnacle™ Lite Posterior and Polyform™. After we review our plans with the FDA and other appropriate regulatory authorities, we will provide instruction following our approved process for removal of existing customer inventory in the coming days.
Consistent with FDA guidance, Boston Scientific recommends that women who have been implanted with the Uphold™ LITE Vaginal Support System and the Xenform™ Soft Tissue Repair Matrix should continue with annual routine check-ups with their doctor. There is no need for patients who are satisfied with their treatment to take additional action. However, any patient with questions or concerns should speak to her healthcare provider. Please refer to the full statement on the FDA website.
It is important to note that there are a variety of surgical mesh products designated for different conditions. The FDA’s recent decision is limited to mesh for the transvaginal repair of pelvic organ prolapse and does not extend to mesh used to treat stress urinary incontinence or for transabdominal repair.
As a global leader in women’s health, Boston Scientific remains steadfast in our commitment to helping women and all patients live better and healthier lives.
