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 POP occurs when the muscles and tissue of the pelvic floor become
stretched, torn or weakened and can no longer support pelvic organs,
leading to their prolapse into the vagina.
Over the past several years, the FDA has received thousands of
reports of complications, including bleeding, organ perforation and
urinary problems, involving the use of mesh for transvaginal POP
repair, the agency said.
These devices have been used by surgeons since the 1950's to repair
abdominal hernias. In the 1970s, gynecologists began implanting
surgical mesh for the abdominal repair of POP and, in the 1990's,
for the transvaginal repair of POP.
The FDA noted that an advisory panel of experts in 2011 recommended
that more data was needed to establish their safety.
Boston Scientific Corp is among a handful of manufacturers that have
collectively faced an estimated 100,000 lawsuits in state and
federal courts over transvaginal mesh, alleging that poor design and
substandard materials can cause side effects such as bleeding,
infection and nerve damage.
Other major defendants include Johnson & Johnson's Ethicon unit and
C.R. Bard.
The FDA on Monday issued an order to reclassify these medical
devices from class II or moderate-risk devices, to class III, which
encompasses high-risk devices. (http://1.usa.gov/1MPbStj)
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In addition, the agency now also requires manufacturers to submit an
application to support the safety and effectiveness of the surgical
mesh, particularly for POP. These orders do not apply other
indications, like stress urinary incontinence or abdominal repair of
POP.
Manufacturers of already available surgical mesh used to treat POP
transvaginally will have 30 months to submit an application for
their devices. Makers of new devices must submit their application
before they can be approved for marketing, the FDA said.
(Reporting by Natalie Grover in Bengaluru; Editing by Maju Samuel)
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