The Food and Drug Administration (FDA) has stopped Boston Scientific and Coloplast from selling the surgical mesh for the repair of organ prolapse within the United States.
The above companies were the only two who were still selling the device that has previously been implanted in to millions of women.
The vaginal mesh was used to strengthen weakened pelvic muscles that cause the bladder and other organs to sag in to the vaginal area. The use of the surgical mesh is not a new idea, and has been used by surgeons since the 1950s.
This news comes at a time where there are several multi-million dollar verdicts against manufacturers of these devices which are currently awarded or upheld on appeal. This includes companies such as Johnson & Johnson.
The FDA issued a statement where they stated that the manufacturers, “Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices.” This was necessary following the device’s reclassification of the mesh as high risk by the FDA in 2016.
“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 pelvic organ prolapse (POP). That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.
Shuren continued, “patient safety is our highest priority, and women must have access to safe medical devices that provide relief from symptoms and better management of their medical conditions. The FDA has committed to taking forceful new actions to enhance device safety and encourage innovations that lead to safer medical devices, so that patients have access to safe and effective medical devices and the information they need to make informed decisions about their care.”
According to the FDA, this action is a “commitment to advance women's health and improve access to safe and effective medical devices.”
Boston Scientific claimed it was “deeply disappointed by the FDA’s 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 pelvic organ prolapse during their lives.”
Whereas Coloplast said it will stop selling the product.
It is important that women who have had the mesh implanted understand that they do not need to take any action if they are not experiencing any complications or symptoms. The FDA claims it has received a significant number of adverse event reports regarding the mesh over the past few years, and in the case a problem does occur the patients should notify a healthcare professional.
This announcement is contrasting to the news recently released by NICE, where they published updated guidelines on the management of urinary incontinence in women, and offered mesh procedures.