The Food and Drug Administration is ordering companies that produce mesh devices for women suffering from pelvic organ prolapse to end the sales of those products immediately.
The companies, “Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices,” the agency said Tuesday in a statement.
The products are supposed to assist in transvaginal repair as a result of POP, but their ability to stay on the market was put in jeopardy three years ago when the FDA labeled them high-risk. That classification meant the manufacturers had to apply for “premarket approval,” the highest bar to clear to keep selling.
The companies have 10 days to say how they will pull the devices off the market.
“In order 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 repair POP,” Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the statement. “That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term.”
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Surgical mesh began to be used for POP-related transvaginal repair in the 1990s, and roughly a decade later, a mesh product got the green light for such surgeries. At the time, the device was considered to pose a moderate risk. But the FDA grew increasingly concerned after reports of negative effects spiked, and the number of patients receiving mesh has dropped.
In their premarket applications, the two device makers failed to show that mesh created a better outcome than the alternative, tissue repair. Both companies, however, will have to check up on patients who have had the mesh implanted and who are part of studies the FDA already ordered.
“Women who have had transvaginal mesh placed for the surgical repair of POP should continue with their annual and other routine check-ups and follow-up care,” the FDA said. “There is no need to take additional action if they are satisfied with their surgery and are not having complications or symptoms.”
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