(Reuters) – The U.S. Food and Drug Administration on Tuesday ordered makers of transvaginal surgical mesh implants to immediately stop their sale and distribution in the United States, the latest action by the agency to tackle safety issues related to the devices.
The FDA said Boston Scientific Corp and Coloplast A/S did not demonstrate a reasonable assurance of safety and effectiveness of these devices in their premarket applications. The companies will have 10 days to submit their plan to withdraw these products from the market, the FDA said in a statement https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm636114.htm.
In 2016, the agency reclassified the mesh as class III or high risk, requiring its makers to obtain approval from the FDA’s most stringent device review pathway in order to continue selling the products.
The devices, made of synthetic or biological material, are commonly implanted in women to repair weakened or damaged tissue and provide support in cases of pelvic organ prolapse.
The prolapse occurs when the muscles and tissues supporting the pelvic organs – the uterus, bladder, or rectum – become weak or loose, resulting in one or more of the organs to drop or press into or out of the vagina.
Boston Scientific and Coloplast are the only companies that still sell and distribute meshes for this use, the FDA told Reuters.
Boston Scientific said it was “deeply disappointed” by the FDA’s decision and will work with the agency to determine the next steps.
“The inaccessibility of these products will severely limit treatment options for the 50 percent of women in the U.S. who will suffer from pelvic organ prolapse during their lives,” the company said in an emailed statement.
Coloplast said the order involved only one of its products, accounting for around 0.2 percent of total revenue. The Danish company declined to comment further.
Tens of thousands of lawsuits have been filed in recent years against medical device manufacturers claiming their transvaginal mesh implants caused pain, perforations, urinary problems, bleeding and other injuries. The lawsuits were filed against Boston Scientific, Coloplast, Johnson & Johnson and C.R. Bard, now a unit in Becton Dickinson and Co.
J&J said it has not sold its mesh product since 2012.
Other companies had to remove their products from the market last year because they did not submit required premarket approval applications, the FDA said.
A large portion of the $929 million in Boston Scientific’s legal reserves at the end of 2018 was related to the company’s surgical mesh, Needham and Co analyst Mike Matson said, adding that products account for around 1 percent of company revenue.
Boston Scientific shares were down 4 percent at $36.24 in late afternoon trading.
(Reporting by Saumya Sibi Joseph and Aakash Jagadeesh Babu in Bengaluru; Editing by Shinjini Ganguli and Bill Berkrot)