FDA: No More Mesh for Prolapse Repair

FDA: No More Mesh for Prolapse Repair

The U.S. Food and Drug Administration on Tuesday ordered makers of transvaginal surgical mesh implants to immediately stop their sale and distribution in the United States, the latest action by the agency to tackle safety issues related to the devices.

In February, an FDA advisory committee concluded that a favorable recommendation for the mesh devices' benefit-risk profile would require a demonstration of superior effectiveness versus native tissue fix at 36 months and at least comparable safety outcomes.

The FDA said it "has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices".

"For these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to fix POP".

Consumer rights advocacy group Public Citizen petitioned FDA to ban the class of devices in 2011.

Women who've had the procedure should continue with routine check-ups. Instead, the device maker is resolving suits on a case-by-case basis. "We are deeply disappointed by the FDA's decision", said Kelly Leadem, a company spokeswoman. The Danish company declined to comment further. Coloplast will work with the FDA and other relevant authorities to ensure the orderly removal of these devices from customer inventories.

To continue selling their devices, the companies had to submit a premarket approval (PMA) application with additional data to prove the effectiveness of surgical mesh for transvaginal fix of POP. Johnson & Johnson (NYSE: JNJ) discontinued sales of mesh products on its own back in 2012. It began to be used for abdominal fix by gynecologists in the 1970s, and for pelvic organ prolapse in the 1990s. Advocates have been trying to persuade the FDA for years about the dangers of the product.

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Geoffrey Cundiff, president of the American Urogynecologic Society, told MedTech Dive he was "not entirely surprised by the announcement", and supports the superiority standard behind it. The company generated $2.6 billion in sales a year ago. The order is the latest in a series of escalating safety actions related to protecting the health of the thousands of women each year who undergo surgery transvaginally to fix POP.

In 2015 the European Commission's Scientific Committee on Emerging and Newly Identified Health Risks recommended that implantation of mesh for the treatment of POP via the vaginal route only be considered in complex cases, and in particular after failed primary fix surgery, or when other surgical procedures have already failed or are expected to fail.

"Then and now they have no reliable evidence about what these devices do", besides in the very short term, he said.

The FDA began slowly chipping away at mesh after it held its first committee meeting in 2011, and thousands of women have been waging a war against the device for years.

But a presentation at the February meeting by former FDA manager turned independent device data analyst Madris Tomes showed there may have been more than 69,000 POP mesh-related MDRs as of January 2019, including 393 deaths. "SUI mesh causes the same complications", she said.

Health Canada added it is also reviewing mesh implants used in the treatment of stress urinary incontinence in women.

"I'd like to see them take it a step forward", Tomes said of FDA extending scrutiny across mesh types.

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