The FDA flexed its little-used muscle. Under Section 522 of the Federal Food, Drug and Cosmetic Act, the agency can request postmarket studies if a device is implanted and if the complications are serious enough.
Transvaginal mesh fit the bill and the order went out 33 manufacturers of surgical mesh for pelvic organ prolapse (POP) and seven manufacturers of single-incision mini-slings for SUI. They were to spend money and a lot of it, to come up with three years worth of monitoring to look for and report rates of mesh erosion, vaginal shortening and scarring, neuromuscular pain, revision surgeries, all of the complications that are ruining the lives of thousands of women.
Women were to be followed for three years and adverse events reported at 6 months, 12, 18, 24 and 36.
That was January; this is the end of September. What has happened? Absolutely nothing.
The manufacturers were given 30 days to respond initially to the 522 orders. Nothing. Now when you look at the FDA’s own website for 522 studies you see that the plans are “pending”, or the study is pending” or “other” – in other words the follow-up that was so important to give mesh sufferers some answers just has not begun as if this were not a crisis.
Clearly the medical device industry understands that the FDA is a lapdog watchdog agency. Has there been any action for noncompliance? Not yet. The agency has the authority to seize products off store shelves or demand a recall. Again a paper tiger.
As if the January 3, 2012 orders for mesh studies were not enough, in May 2011, many makers of metal-on-metal (MoM) hips were required to also begin the expensive and arduous postmarketing follow-ups on people living today with metal hip implants.
These too have devastating life-altering injuries as emerging science shows that metal debris can and does get into the blood stream of many hip implant patients, with the potential to create metallosis and necrotic tissue around the hip. The revision rate is unacceptably high, so much so that the DePuy MoM hip (Johnson & Johnson) had to be pulled from the market leaving 93,000 patients wondering when their number will be up.
Still no postmarketing plans have gotten underway. At least with metal hips, the agency’s website acknowledges the plan is “overdue”!
They certainly are, and so is a federal agency that has some teeth.