Boston Scientific Corp. is adding new safety warnings to the labels for its most heavily litigated products — surgical-mesh devices used to repair common pelvic disorders in women.
Boston Scientific, like other med-tech companies that operate in Minnesota, is facing thousands of lawsuits from women who say they were injured when their implanted pelvic meshes and slings became infected or created erosion of the surrounding tissue. On Tuesday, the company said it is adding “erosion” and “ongoing pain” to the list of warnings and precautions disclosed on device labels worldwide.
The labels will now say that meshes and slings are considered permanent implants, that removal may be complicated or impossible, and that the treatment for post-surgical device erosion may require surgical removal of the device.
Transvaginal slings are implanted to treat stress urinary incontinence, while surgical meshes are used to strengthen tissue in patients with pelvic organ prolapse.
A study of 10 million women, published last year in the journal Obstetrics & Gynecology, estimated that the lifetime risk of having surgery for either of the conditions is about 20 percent by the age of 80.
The changes to the device labels, which were implemented in May and announced Tuesday, affect five Boston Scientific brands of transvaginal slings (Advantage, Lynx, Obtryx, Obtryx II and Solyx) and three types of mesh (Uphold LITE, Pinnacle LITE, and Upsylon Y).
The changes were announced in “urgent” advisory letters sent last month to doctors worldwide. The company letters were followed by announcements from regulators in Europe publicizing the changes.
The devices are not being recalled, and there was no request to have devices sent back to the company. The notice says there is no impact to previously implanted devices. A company spokesman said the changes were prompted by a review of data by company officials and medical device regulators in Australia.
As of May 2, Boston Scientific was facing more than 36,000 product liability cases related to the devices, with plaintiffs asserting flaws in design and manufacturing, failure to warn of known dangers, breach of warranty, fraud, violations of state consumer protection laws and loss of consortium claims.
Securities filings say the company has entered agreements to settle about 11,000 of the cases so far, without any admission of liability or wrongdoing. The company has also responded to written information requests about the devices from state attorneys general.