Earlier this month, the US Food and Drug Administration
(FDA) ordered the manufacturers of all remaining surgical mesh products
indicated for the transvaginal repair of pelvic organ prolapse (POP) to stop
selling and distributing their products in the US immediately.
The FDA had reclassified these mesh products as class III
(high risk) in 2016 and the manufacturers, Boston Scientific and Coloplast,
were not able to comply with the premarket review standard that now applies to
them as they could not provide enough evidence as reasonable assurance of their
safety and effectiveness. The companies will have 10 days to submit their plan
to withdraw these products from the market.
In 2002, the first mesh device for transvaginal repair of
POP was cleared for use as a class II moderate-risk device.
A practice advisory issued by the American College of
Obstetrics and Gynecology (ACOG) in response to the FDA announcement specified
that the FDA announcement applies only to mesh placed vaginally to treat POP.
The FDA order does NOT apply to transvaginal mesh for stress urinary
incontinence. Additionally, the FDA order does not apply to mesh placed
abdominally (sacrocolpopexy via laparotomy or endoscopy) for prolapse repair.
(Source: US FDA, ACOG)
Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of
Medical Associations in Asia and Oceania
(CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of
India
Past National President
IMA
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