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FDA Finally Recognizes That Transvaginal Mesh Puts Women at a Painful Risk

After 100,000 lawsuits, the FDA has finally cracked down on transvaginal mesh, a medical device known to cause chronic pelvic pain, or worse, in women.
January 5, 2016, 10:45pm
Photo by Victor Torres via Stocksy

Thanks to late-night law firm advertisements urging you to CALL NOW if you or a loved one has suffered from complications due to transvaginal mesh, the controversial medical device has become, at least by name, ominously ubiquitous. And while these commercials can be easily seen as sensational, the panic surrounding pelvic mesh when used to treat stress urinary incontinence (SUI) or pelvic organ prolapse (POP), has proven warranted. Horror stories about life after having the medical device implanted often include instances of chronic vaginal pain or mesh erosion into the vagina.

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Made of polypropylene plastic and originally developed to repair hernias, pharmaceutical companies now market pelvic mesh to women who experience SUI, involuntary urine leakage, and POP, a condition in which the tissue that holds certain organs in place becomes weak and allows them to prolapse, or sag into (and in some cases out of) the vagina. Pelvic organ prolapse is, of course, a very bad thing; in theory, pelvic mesh was ushered onto the market to make the fix for it simple. Even non-surgeons, like gynecologists, can be trained to insert it through the vagina.

So in 2007, when it happened to Amy Gezon, a Salt Lake City mom of three, in the form of her bladder and rectum bulging into her vagina, her OB/GYN recommended that she have a mesh—manufactured by Boston Scientific—implanted. Gezon has since recalled the events that followed her surgery in various blogs, newspapers, and in a 2011 FDA hearing. Talking to a medical mesh watchdog site, Mesh Medical Device News Desk, she explained that because of the mesh implant she could no longer go to the bathroom without "self-catheteriz[ing]" and had tried her best to manage the constant sharp pain and inflammation it caused. On the brink of pain-induced suicide, she finally decided to have the mesh removed, though for that she had to travel from Utah to Atlanta, as there are far fewer surgeons trained in mesh removal than implantation. "Immediately I was peeing again," she told the publication. "The pain was 90 percent better [after the mesh was removed], and the pubic bone pain resolved almost immediately." She now refers to herself as a mesh survivor.

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Jane Akre, a journalist-turned-medical mesh activist (her Wikipedia page also notes her as a whistleblower), started Mesh Medical Device News Desk four years ago. While working as a national news editor for "an online site" she often received correspondence from women urging her to cover the topic. "At first, I didn't quite entirely believe what they were saying because they were saying the FDA doesn't regulate medical devices, etc., and none of that made sense to me. But when I started looking into it, I found that all of it was true, and the story was even worse than what they were pointing out." Akre's thorough research lead her to be tapped by the Corporation Action Network to compile a report on the product and petition the FDA.

Read More: Living with an Illness That No One Believes

Because of the volume of stories like Amy's, told by people like Akre, in 2011 the FDA revised their stance on the product, saying "serious complications associated with surgical mesh for transvaginal repair of POP are not rare." (Emphasis theirs.) But beyond that, they didn't do much else. Meanwhile, the lawsuits against pharmaceutical companies that manufacture medical mesh, like Boston Scientific, were piling up. In 2014, Endo International finally agreed to pay $1.2 billion to the women who suffered injuries from their product. And last year, Boston Scientific had to pay $100 million to one woman who was unable to have sex and left with damaged organs after using the company's vaginal implant. According to Reuters, the total number of lawsuits against these companies has reached 100,000.

Though the complications from transvaginal mesh have already negatively affected countless women, there isn't only grim news. On Monday, the FDA announced that they will be enacting tighter regulations on mesh manufacturers. In addition to upgrading the risk of the medical device to a level three, signifying high risk, manufacturers will also have to submit an application within 30 months "to support the safety and effectiveness" of their product before it can be approved by the FDA for marketing to treat POP. The regulations, however, don't apply to transvaginal mesh used to treat SUI; right now there are thousands of women who have already received medical mesh implants without this guarantee of safety.

Read More: Your Worst UTI Stories

"These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse," said Dr. William Maisel, the deputy director of science and chief scientist for the FDA's Center for Devices and Radiological Health in the FDA's press release. "We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures."

Akre calls the FDA's actions this week a step in the right direction, but just a step. "We'll take a little crumb here or there," she says.

Medical mesh certainly isn't the only way to treat conditions like SUI and POP. Dr. Tom Margolis, a Bay Area pelvic surgeon, has long maintained that surgical mesh is harmful, and he doesn't use it in his practice. In 2011, he testified to the FDA about the complications of transvaginal mesh: "Transvaginal implantation of synthetic mesh for any reason is a surgical theory and technique that defies core surgical doctrines." On his website, he echoes this, warning other surgeons that "transvaginal mesh should never be used," and he says to patients, "please instruct your surgeon not to use such systems."