Health Letter, May 2019
By Michael Carome, M.D.
If you’re not outraged,
you’re not paying attention!
Read what Public Citizen has to say about the biggest blunders and outrageous offenses in the world of public health, published monthly in Health Letter.
On April 16, the Food and Drug Administration (FDA) finally ordered the manufacturers of all surgical mesh products for the transvaginal repair of pelvic organ prolapse to stop selling and distributing their products in the U.S. immediately. In its announcement, the agency noted that it had determined that the manufacturers of these devices, Boston Scientific and Coloplast, “have not demonstrated a reasonable assurance of safety and effectiveness for these devices.”
Although the FDA’s long-overdue action was welcome news, the ban came too late for thousands of women who have been irreparably harmed by these devices. Since at least 2011, there has been clear evidence that surgical mesh products for the transvaginal repair of pelvic organ prolapse are unsafe and lack any clinically significant benefits compared with pelvic surgery without transvaginal mesh. Nevertheless, the FDA allowed the products to remain on the market.
The saga of these surgical mesh products epitomizes the serious flaws in the FDA’s oversight of most moderate-to-high-risk devices marketed in this country. The bar for FDA approval or clearance of medical devices is set far too low, whereas the bar for removing devices that are subsequently found to be unsafe is set far too high.
Pelvic organ prolapse involves bulging or descent of one or more of the pelvic organs, such as the bladder, rectum or uterus, into the vagina, sometimes past the opening of the vagina. This common condition is caused by weakness in the connective tissue and muscles that surround and support the pelvic organs. Most women with pelvic organ prolapse have no symptoms. For symptomatic patients, treatment can involve surgical or nonsurgical interventions. In surgical procedures, non-absorbable mesh often is implanted transvaginally (through incisions and punctures made through the wall of the vagina) with the intent of reinforcing the tissues around the pelvic organ that prolapsed and increasing the longevity of the repairs.
Starting in the 1990s, the FDA cleared several dozen surgical mesh products specifically designed for transvaginal repair of pelvic organ prolapse under a regulatory pathway known as the 510(k) premarket notification. Under the 510(k) pathway, manufacturers do not need to conduct clinical trials in human subjects to assess the devices’ safety and effectiveness.
In 2011, the FDA reported that over the preceding three years (from 2008 to 2010), the agency had received approximately 1,500 reports of serious complications that were associated with surgical mesh devices used for transvaginal repair of pelvic organ prolapse. These complications included erosion (in which tissue between the implanted non-absorbable mesh and the lining of the vagina breaks down and the mesh becomes exposed on the surface of the vagina), infection, pain and urinary problems such as incontinence. There were also reports of injuries to the bowels, bladder and blood vessels during transvaginal insertion of the mesh for pelvic organ prolapse repair. In some cases, vaginal scarring, mesh erosion, and contraction or shrinkage of the mesh led to a significant decrease in patient quality of life due to severe pelvic discomfort and pain, including pain during sex — life-altering adverse effects that could not be corrected with further surgery.
Furthermore, women whose transvaginal pelvic organ prolapse surgery involved surgical mesh did not experience better outcomes in terms of symptom relief and quality of life — the clinically significant indicators for measuring treatment success for this condition — than women who underwent transvaginal pelvic organ prolapse repair surgery without mesh.
Based on this and other evidence, Public Citizen in 2011 petitioned the FDA to ban all currently marketed transvaginal surgical mesh products for the transvaginal repair of pelvic organ prolapse and to require that any future such devices be reviewed under the agency’s more rigorous premarket approval (PMA) application process, which does require clinical testing in human subjects to assess the devices’ safety and effectiveness.
In 2014, the FDA denied Public Citizen’s petition but did issue a proposed order, which was finalized in 2016, requiring that all manufacturers of surgical mesh products for the transvaginal repair of pelvic organ prolapse submit PMA applications to support the safety and effectiveness of these products. However, the agency gave manufacturers nearly three years to submit their PMA applications while allowing these mesh products to remain on the market in the meantime, resulting in avoidable harm to many more women.
In testimony before an FDA advisory committee that was convened on February 12, 2019, to consider the three remaining surgical mesh products for the transvaginal repair of pelvic organ prolapse that were still on the market, Public Citizen once again urged the agency to ban all such products, noting that because of the FDA’s inadequate actions over nearly a decade, thousands of women have been unnecessarily harmed, many permanently.
The agency’s reckless delay in removing these mesh products from the market belies the assertion on April 16 by Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, that “patient safety is our highest priority.” If the agency had granted our 2011 petition promptly, thousands of women would have been spared serious, preventable, life-altering harm.
Unless the FDA fundamentally changes its approach to the oversight of medical devices, similar tragedies will occur.