The FDA announced Tuesday that it was taking action to protect women from painful and debilitating injuries from transvaginal mesh by ordering manufacturers to immediately stop selling the surgical implants.
After receiving more than 100,000 reports of permanently debilitating and painful complications from transvaginal mesh and years of consumer advocates demanding the removal of the medical implants from the market, the regulatory agency issued a press release April 16, announcing it is pulling pelvic mesh from the market due to manufacturers failure to provide proof that the implants are safe or even effective.
During the past decade, concerns have rapidly escalated over the risk of devastating and painful injuries from the pelvic organ prolapse (POP) implants. These include massive infections, as well as organ perforation and erosion of the mesh into the vaginal wall.
Transvaginal mesh manufacturers, such as Ethicon, C.R. Bard and Boston Scientific have faced more than 100,000 lawsuits from US women. They have paid out billions in financial compensation to resolve allegations that the mesh was patently defective and exceptionally dangerous. However, at least two of the manufacturers were still marketing and selling the products despite these substantial issues.
Manufacturers Failed to Show Implants Were Safe
The FDA indicates that Boston Scientific and Coloplast failed to provide adequate assurances that the products were safe or even effective to keep the products on the market. In 2016, federal regulators reclassified pelvic mesh as high risk, class III medical devices.
Following the reclassification of the devices, the FDA required companies who continued selling pelvic mesh to file for premarket approval to prove the safety and efficacy of the devices. However, manufacturers never satisfied these requirements. Now, the FDA has given the companies ten days to determine how they will remove the dangerous and controversial mesh from the US market.
“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,” wrote the director of the FDA’s Center for Devices and Radiological Health, Dr. Jeffrey Shuren. “That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term.”
The FDA’s move makes the US among the expanding number of countries that are banning the medical implants. Over the past couple of years, the United Kingdom suspended the use of these products, while Australia outright banned them due to the devices’ exceptionally high risks.
Transvaginal Mesh Litigation
Tens of thousands of women filing cases across the nation has made the transvaginal mesh litigation among the largest in US mass tort history.
In July 2011, the FDA warned the public that the agency had received thousands of adverse event reports regarding extensive problems with pelvic mesh products between 2008 and 2010. Following this announcement, the number of cases began increasing rapidly.
After reviewing the devices, the FDA finally determined that there was no evidence that vaginal mesh is any more beneficial than traditional surgery to treat pelvic organ prolapse. In early 2012, the agency sent letters to several manufacturers, ordering them to conduct additional trials and studies to evaluate the implants' safety. Most vaginal mesh manufacturers opted to stop making the devices voluntarily to avoid the additional costs of safety studies.
The transvaginal mesh safety reclassification meant that the devices needed to meet the FDA’s most strict pre-market approval requirements. Tuesday’s press release means that manufacturers failed to meet these standards.
Federal regulators indicate that women who already have the medical implants continue annual and other routine check-ups. There is no additional action necessary if they are not suffering from complications.
However, women who are experiencing issues, such as persistent vaginal bleeding, discharge, pelvic organ pain or pain during intercourse, should contact their primary care provider. Women who were preparing to undergo transvaginal mesh surgical repair should talk to their doctors about alternatives.