Update: Could The FDA Be Predicting a Future Transvaginal Mesh Recall?
About a year after the U.S. Food and Drug Administration (“FDA”) issued a public health alert categorizing the risks for vaginal mesh side effects as ‘not rare,’ the agency announced that it may reclassify the devices as Class III, which would require manufacturers to get pre-market approval for all future products. But the question remains: could this lead to a transvaginal mesh recall?
The latest update by the FDA was announced Oct. 4 via the agency’s website, and followed a September 2011 review of the health issue by the agency’s Obstetrics & Gynecology Devices Advisory Committee.
In that meeting, the panel of health experts agreed to institute more rigorous testing of the mesh devices, and recommended that the vaginal mesh pelvic floor repair systems be classified as Class III devices.
That said, last week’s update could mean bad news for transvaginal mesh manufacturers C.R. Bard Inc., Johnson & Johnson subsidiary, Ethicon, American Medical Systems and Boston Scientific.
In its statement, the FDA vowed to further assess the safety of vaginal mesh through “epidemiological research on safety and effectiveness of surgical mesh, as a part of [it’s] effort to better understand possible adverse events associated with surgical mesh for stress urinary incontinence (“SUI”) and pelvic organ prolapse (“POP”).”
The agency also plans to continue mandating post-market surveillance studies by vaginal mesh manufacturers. This will follow the trend that started Jan. 3, 2012, when it issued 88 post-market study orders to 33 manufacturers of transvaginal mesh for POP and 11 orders to seven mini-slings for SUI.
Hopefully, the FDA’s latest efforts will prevent more women from being implanted with this surgical material and suffering from erosion, infection, chronic pain, urinary problems and recurrence of stress urinary incontinence (“SUI”) and pelvic organ prolapse (“POP) afterward.
It is estimated that between Jan. 2008 and December 31, 2010, the FDA received almost 3,000 adverse event reports of injury, malfunctions and even death from transvaginal mesh devices.