Citing safety concerns for women, the FDA took the most severe measure available to the federal agency that it would halt sales of the controversial pelvic mesh.
Transvaginal mesh products have been used worldwide for about 15 years, mostly to treat pelvic organ prolapse (POP) and stress urinary incontinence problems in women. Since that time, 27 clinical studies have shown that one in 12 patients have suffered TVM complications. It has been estimated that 50 percent of women by the age of 50 years will have some degree of POP and more than 10 percent by the age of 80 will require surgery.
The number of serious complications from the device has increased significantly over the years, prompting the F.D.A. to ask manufacturers to submit more evidence that the devices were safe and would benefit patients.
In announcing its decision on Tuesday, the F.D.A. said that the two manufacturers, Boston Scientific and Coloplast, had not demonstrated a reasonable assurance of safety and effectiveness for the devices.
“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,” said Dr. Jeffrey Shuren, director of the F.D.A.’s Center for Devices and Radiological Health. “We couldn’t assure women that these devices were safe and effective long term.
Banning a medical device is typically a last resort measure for the FDA after other measures have failed. Out of the 10 million women worldwide who’ve had the mesh implanted to treat pelvic organ prolapse, approximately 10 to 15 percent have suffered complications, in some cases requiring the mesh to be removed in a second surgical procedure.
There have been nearly 100,000 legal claims filed against the manufacturers of the failed medical device. The seven companies that make or have made the pelvic mesh so far have agreed to pay out more than $8 billion.
The FDA has issued several safety warnings since 2008 concerning the flood of complaints and reports of injuries caused by transvaginal mesh devices. In 2016, the FDA reclassified mesh implants indicated for prolapse repair as Class III (high risk) medical devices, which among other things, barred such product from the FDA’s 510(k) approval program. This program allowed Prolift and similar mesh devices to come to market without the benefit of human trials because their manufacturers were able to convince the FDA that they were “substantially equivalent” to implants that had already gone through the agency’s stricter pre-market approval process.
Now that the transvaginal mesh has been finally banned by the FDA, it’s beneficial to reflect on why they were allowed to remain on the market. One of the problems is that the manufacturers over marketed these products to women who did not need them and encouraged ob/gyn physicians without specialized training to implant them. Further, many of the mesh products were poorly designed and inadequately tested. The final failure of the manufacturers was failing to warn doctors and patients of the severity of the potential side effects.
Australia was the first country to ban the medical device. At the time of that ban, the FDA was exhorted to act in a similar fashion. They finally did but more women have suffered as a result of their slow action.
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