The Public Health Notification came after the agency had received numerous complaints from women who had been implanted with pelvic mesh to treat stress urinary incontinence (SUI) and/or pelvic organ prolapse (POP).
The first FDA Safety Communication said mesh complications are “rare” and include mesh exposure through the vagina, pain infection, bleeding, pain during sexual intercourse, organ perforation and urinary problems as well as recurrent prolapse, nerve and muscle problems, vaginal scarring and shrinkage and emotional problems as a result.
This report was issued after the FDA received over 1,000 adverse event reports.
But by January 2008 through the end of 2010, the number of injury complaints increased three fold. “Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remains high,” said the agency.
So by July 13, 2011 the FDA reversed itself.
In FDA UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse, this second notice said complications associated with mesh used for POP repair are “not rare.”
The agency identified mesh used for POP repairs a particular culprit and one that “introduces risks not present in traditional non-mesh surgery for POP repair.”
Earlier this year, the FDA moved to reclassify POP mesh, the larger polypropylene mesh used to shore up a sagging uterus or colon as a higher risk Class III. It gave mesh manufacturers 30 months to prove their mesh is safe or take it off the market.
Mesh for SUI or incontinence remains on the market without that special warning. It is a class II device and does not require any clinical trials proving safety or efficacy before it is sold to doctors. That is notable since there are more lawsuits filed over injuries caused by SUI mesh, probably because it is more commonly used than POP mesh.
So how do you report to let the FDA know you are not alone? The only way the agency can act is if it knows so reporting is very important. Please check the report your doctor submits to make sure it reflects your true story.
MedWatch Online Voluntary Reporting Form (3500) is here.
Or you or your doctor could report directly to the Manufacturer and User Facility Device Experience (MAUDE) database on medical devices that have caused injury.