Thomas M. Burton, Wall Street Journal: Feburary 12, 2019.
Officials should consider women’s reports of pain, sexual dysfunction and other maladies as they re-evaluate a medical device used in women’s pelvic surgery that has triggered thousands of lawsuits, an advisory panel said.
The panel of outside doctors, convened to advise the Food and Drug Administration, recommended that the agency evaluate women’s medical self-reports as it decides whether synthetic mesh products should stay on the market. Such recommendations are generally, but not always, followed by the federal agency.
The mesh product—used to treat a condition called pelvic organ prolapse, in which organs like the bladder, uterus and others sag into the vaginal area—was first cleared by the FDA for U.S. marketing in 1996.
The condition can be treated with conventional surgery using the patient’s own tissue, but the synthetic mesh product is considered more permanent by many surgeons, at least in proper surgical hands. The product is also used in some other conditions such as hernia repair and urinary incontinence, which some doctors say present lower risk.
But since vaginal mesh was introduced, complications such as vaginal pain, bleeding and scarring have been extensive. Billions of dollars in damages have been awarded after findings of crippling conditions and multiple reoperations in many patients.
Vaginal mesh entered the U.S. market through a quick approval process that required fewer safety studies. Now, the FDA is insisting that the two remaining companies on the market prove the benefits of their products through clinical studies. The panel suggested that questionnaires filled out by women be part of that process.
The FDA issued a public-health notice in 2008 advising of serious complications associated with the mesh in some cases. By 2011, it updated that advisory to let the public know that these complications aren’t rare.
The agency said it did a search of its database of device injuries through October 2018 to help determine the seriousness of the issue. It identified 10,391 reports of serious injury and 77 deaths potentially related to the products.
“Women’s lives have been changed, and in some cases ruined,” Diana Zuckerman, president of the National Center for Health Research, a consumer group in Washington, D.C., said at the hearing.
Many women have filed lawsuits in federal and state courts against manufacturers.
Boston Scientific, one of two companies with mesh products on the market, said in an FDA filing for the Tuesday hearing that it “firmly believes that the totality of clinical evidence supports the positive benefit/risk profile of transvaginal mesh devices to treat pelvic organ prolapse.”
The other such company, Coloplast Corp., said that patients and surgeons need options and that surgical mesh “is a safe, effective and important treatment option.”
Vaginal mesh is a prime example of what critics say has been the FDA’s lenient approval process for many medical devices. It was originally cleared through a pathway known as 510K, in which a device is allowed onto the U.S. market based on being substantially equivalent to an existing product already being sold. That process doesn’t require a gold-standard safety-and-effectiveness study.
“Surgical mesh for repair of pelvic organ prolapse is a quintessential example of the fundamental deficiencies in the FDA’s oversight of medical devices, particularly those that are permanently implanted,” said Michael Carome, director of the Public Citizen Health Research Group, in a statement before the hearing.[…]
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