FDA’s Fast-Tracked Clearance Process Comes Under Fire in Wake of Multi-Million Dollar Vaginal Mesh Settlement

A recent Public Broadcasting Service (PBS) episode of Need to Know discussed the issue of medical devices, specifically vaginal mesh,  cleared through the U.S. Food and Drug Administration (FDA). According to the Government Accountability Office (GAO), hundreds of medical devices are recalled annually.

A South Dakota nurse who described her life prior to transvaginal mesh as being very active. She was diagnosed with pelvic organ prolapse (POP) and her physician recommended she undergo a surgical procedure described as minimally invasive and involved the transvaginal implantation of surgical mesh into her pelvic area. In her case, said PBS, Ethicon’s Prolift device was used. Ethicon is a unit of Johnson & Johnson.

As we’ve explained, vaginal mesh implants are medical devices approved to treat POP, a condition in which weakened pelvic muscles cause organs to slide out of place. The device is also approved to treat stress urinary incontinence (SUI) and is meant to strengthen pelvic walls. Complication reports, mounting litigation, and growing questions over the lack of clinical testing of these devices have raised questions about the devices’ safety and efficacy; many question if the devices pose more risks than benefits.

When the woman asked her physician about her body’s potential rejection of the vaginal mesh device, she was told that the device would simply be explanted, or removed. She told PBS that nothing in the brochure she read indicated that the mesh would be permanently place or that it would become impossible to remove the entire device. In fact, she was advised that the surgery would be quick. Instead, her recovery took an immediate turn and she began suffering from unremitting and severe pain, she told PBS, She said she was unable to sit and it took 15 days for her bladder to begin working on its own. The only relief, she said, was to lie in bed and prop up her legs.

Five months later, she sought explantation; however, the device became so enmeshed in her tissue’s that parts of the vaginal device remain in her body, even after 22 surgeries, said PBS. Sadly, this is not an isolated case and many women have made similar allegations, describing mesh erosion so significant and widespread that the mesh cannot ever be completely removed. In fact, thousands of woman have reported serious complications associated with vaginal mesh devices and thousands of lawsuits have been brought against the makers of these devices.

She describes her life today as devastating and said that she and her husband reached out to the manufacturer at least five times for assistance. After receiving no help, the couple brought a lawsuit against Ethicon and Johnson & Johnson. An Atlantic City jury ordered Johnson & Johnson to pay $7.8 million in punitive damages for her pain and suffering and $3.35 in compensatory damages.

Meanwhile, the devices were approved through a fast-track process known as the 510(k). Under the 510(k), a formal review for safety and efficacy is neither required nor performed. Because the 510(k) process has been used to gain clearance for other controversial products, such as metal-on-metal hip implants, it has drawn increasing criticism. PBS pointed out that, in 2001, the FDA commissioned an independent report concerning the way in which it clears low- to moderate-risk devices, such as vaginal mesh. The expert panel found that the process is “flawed,” recommending that the agency develop a “new framework.” The FDA said its process should “not be eliminated.”

The FDA finally issued a warning that complications associated with transvaginal mesh implants are “not rare” and also stated that no clear evidence exists that transvaginal mesh is better than non-mesh methods for treating POP and SUI and has asked 33 manufacturers to conduct post-market studies evaluating the dangers of transvaginal mesh. As for Johnson & Johnson, it recalled the device involved in this lawsuit, along with three other, but maintains the recall was not over safety issues.

According to an agency Safety Communication issued last summer, the most common reported adverse events related to transvaginal mesh include: Mesh erosion through the vagina (exposure, extrusion, protrusion); pain; infection; bleeding; pain during sexual intercourse (dyapareunia); organ perforation; and urinary problems.

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