The Food as well as Drug Administration on Tuesday ordered Boston Scientific as well as Coloplast to stop selling surgical mesh used for some pelvic operations.
The agency said the companies “have not demonstrated a reasonable assurance of safety as well as effectiveness for these devices.” The companies have 10 days to submit their plans to withdraw the products through the market.
Shares of Boston Scientific as well as Coloplast fell about 4 percent.
Boston Scientific said the idea was “deeply disappointed by the FDA’s decision “as well as believe the inaccessibility of these products will severely limit treatment options for the 50% of women inside the U.S. who will suffer through pelvic organ prolapse during their lives.”
“Patient safety is usually always our highest priority as well as we will work closely with the agency to understand its direction as well as determine next steps,” the idea added.
Coloplast said the idea will comply with the FDA’s order as well as stop selling the product as well as said the idea represents only 0.2% of its total revenue.
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Manufacturers were required to submit applications with the FDA as well as receive approval in order to keep selling the devices inside the U.S. after the agency reclassified them in 2016. The agency wanted evidence showing they worked better than surgery without using the mesh to repair pelvic organ prolapse, Jeffrey Shuren, director of the FDA’s Center for Devices as well as Radiological Health, said in a statement.
“in which evidence was lacking in these premarket applications, as well as we couldn’t assure women in which these devices were safe as well as effective long term,” he said.
The mesh was used for transvaginal repair of pelvic organ prolapse, a condition where muscles supporting the pelvic organs become weak or loose, allowing the organs to drop into or out of a woman’s vagina. Surgical mesh has been used to fix the condition since the 1950s. However, the FDA in recent years has warned about the risks associated with the devices.
Boston Scientific was the subject of a CBS “60 Minutes” investigation last spring in which examined how the the faced 48,000 lawsuits claiming its mesh “can inflict life-altering pain as well as injury.”
The FDA said about 1 in 8 women has surgery to repair the condition, as well as a subset of these surgeries are completed transvaginally with the use of surgical mesh. However, the percentage of women undergoing transvaginal POP mesh procedures has decreased in recent years after the FDA began issuing warnings about risks associated with the procedure.
Johnson & Johnson stopped selling its mesh products in 2012, citing “changing market dynamics.”