After thousands of lawsuits, FDA bans mesh used in pelvic prolapse procedures
After years of patient complaints about injuries and tens of thousands of lawsuits, the federal Food and Drug Administration yanked from the market a surgical mesh widely used to repair pelvic conditions in women.
The agency has been slow to act on transvaginal mesh, which has been in use since the 1970s, with surgeons increasing its use in the 1990s. That in turn created an avalanche of complaints from safety advocates and women patients, who said the implant and procedure caused pain, bleeding, and scarring. This was not the surgical innovation, they said, that was supposed to remedy the pelvic tissue collapse that can cause the bladder or reproductive organs to slip out of place, causing pain, constipation and urinary leakage.
The FDA issued a series of increasing warnings about mesh, finally reclassifying it in 2016 as high-risk and ordering its makers to produce medical-scientific evidence about the device’s long-term safety.
Women sought action, instead, through the civil justice system, as the New York Times reported:
Litigation over …. transvaginal mesh … ranks as one of the largest mass tort cases in the nation’s history in terms of claims filed, number of corporate defendants and settlement dollars. Seven medical device manufacturers, including Boston Scientific and Johnson & Johnson, are paying nearly $8 billion to resolve the claims of more than 100,000 women.
In lawsuits and media reports, women told how they had to undergo repeated corrective surgeries because the mesh sometimes shifted out of place, puncturing internal organs or the abdomen wall. If surgeons needed to remove or reposition the mesh, they reported that too often it had melted into a hard-to-extract mess in surrounding tissues.
Women who have the mesh implants may need to take precautions, the Associated Press reported:
The [FDA] said … that women with the pelvic mesh should continue regular checkups. There is no need to have the mesh removed if patients are not having problems or symptoms. The FDA order applies to mesh that is inserted through the vagina with a small incision, not mesh inserted through the abdomen with a larger incision. About 1 in 8 women in the U.S. undergo some form of surgery to treat pelvic collapse problems, according to the FDA.
To be clear, though the mesh now is not allowed by the FDA for the larger and “more injury producing” pelvic prolapse procedures, the implant still can be used in urinary incontinence surgeries. There, small mesh implants have an “unacceptably high complication rate … in the range of 5 to 15 percent,” the newspaper noted, quoting a lawyer who has won big cases against the device makers.
The mesh mess has become part of a growing and infuriating catalog of medical mistreatments of women. Anguished patients recently assailed the FDA for failing to inform and safeguard them from risks with breast implants. The agency has been assailed for allowing on the market the Essure birth control implant — albeit with heavy restrictions — after women reported it caused pain, bleeding, and allergic reactions. The maker withdrew the device.
The FDA also has come under fire for its limp oversight of minimally invasive gynecological surgeries that are supposed to be faster, easier, and more convenient for patients, while causing them less scarring and complications. Instead, research studies have shown the procedures may spread cancers, especially if a tissue grinding device — a so-called morcellator — is used. The FDA has issued sharp warnings about the morcellator but has declined to ban it, and surgeons keep using it. The agency also has cautioned surgeons about using robot devices for mastectomies and other procedures still not FDA cleared.
In my practice, I see the harms that patients suffer while seeking medical services, including the ordeals that specialists put women through in the name of “innovation.” Yes, pioneering practices can change and save lives, and it is part of the medical culture for surgeons to be bold and aggressive. But patients should not be experimental subjects without their informed consent. This means they are told clearly and fully all the important facts they need to make an intelligent decision about what treatments to have, where to get them, and from whom.
Some patients may seek select surgeons and hospitals based on their reputations built on specialization or technique. And it is true that surgeries, unlike prescription drugs or medical devices, may not be subject to FDA oversight. But surgeons cannot have free rein in how they treat patients. Surgical colleagues, nurses, hospitals, regulators, and lawmakers need to be vigilant about doctors’ practices to safeguard the vulnerable from MDs excessive risk-taking. Medical scientists, with encouragement and support from agencies like the FDA, need to conduct rigorous studies about surgeries to show if they benefit patients.
As more women become doctors, maybe the field also will rid itself of what is dubbed the “Yentl syndrome” — the description, the Vox news site reported, of “what happens when women present to their doctors with symptoms that differ from men’s — they often get misdiagnosed, mistreated, or told the pain is all in their heads.” As Vox underscored, “This phenomenon can have lethal consequences,” for example, when women need heart care but don’t seek it because their symptoms differ — they may not, for example, experience as many men do a stabbing pain in the chest and radiating from an arm and shoulder.
Author Caroline Criado Perez has written a new book, “Invisible Women: Data Bias in a World Designed for Men,” that tackles the Yentl syndrome and more. It’s yet another reminder that we need to do much better with the medical care for half the world’s people.