FDA issues proposals
to address risks associated with surgical mesh for transvaginal repair of
pelvic organ prolapse
The U.S. Food and Drug
Administration today issued two proposed orders to address the health risks
associated with surgical mesh used for transvaginal repair of pelvic organ
prolapse (POP). If finalized, the orders would reclassify surgical mesh for transvaginal POP from a
moderate-risk device (class II) to a high-risk device (class III) and require
manufacturers to submit a premarket approval (PMA) application for the agency
to evaluate safety and effectiveness.
POP occurs when the internal
structures that support the pelvic organs such as the bladder, uterus and
bowel, become so weak, stretched, or broken that the organs drop from their
normal position and bulge (prolapse) into the vagina. While not a
life-threatening condition, women with POP often experience pelvic discomfort,
disruption of their sexual, urinary, and defecatory functions, and an overall
reduction in their quality of life.
“The FDA has identified clear
risks associated with surgical mesh for the transvaginal repair of
pelvic organ prolapse and is now proposing to address those risks for more safe
and effective products,” said William Maisel, M.D., M.P.H., deputy director of
science and chief scientist at the FDA’s Center for Devices and Radiological
Health. “If these proposals are finalized, we will require manufacturers
to provide premarket clinical data to demonstrate a reasonable assurance of
safety and effectiveness for surgical mesh used to treat transvaginal POP
repair.”
Surgical mesh is a medical device that is used to provide additional
support when repairing weakened or damaged tissue. Many mesh products come in
kits that include instruments specifically designed to aid in insertion,
placement, fixation, and anchoring of mesh in the body. Instruments provided in
kits will be reviewed as part of the regulatory submission for the mesh
product. Instruments are also provided separately from the mesh implant, and
the FDA is proposing that this urogynecologic surgical instrumentation be
reclassified from low-risk devices (class I) to moderate-risk devices (class
II).
Beginning in Jan. 2012, the FDA issued orders to manufacturers of
urogynecologic surgical mesh devices to conduct postmarket surveillance
studies (522 studies) to address
specific safety and effectiveness concerns related to surgical mesh used for
transvaginal repair of POP.
In Sept. 2011, the FDA’s Obstetrics and
Gynecology Devices Panel
recommended that surgical mesh for transvaginal POP be reclassified from class
II to class III and require PMAs.
In July 2011, the FDA provided an updated safety
communication about serious
complications associated with transvaginal placement of surgical mesh used to
treat POP. At that time, the FDA also released a review of urogynecologic
surgical mesh adverse events and
peer-reviewed scientific literature that identified serious safety and
effectiveness concerns. The FDA previously communicated about serious
complications associated with transvaginal placement of surgical mesh to treat
POP and stress urinary incontinence (SUI) in an Oct. 2008 FDA Public Health Notification.
Surgical
mesh indicated for surgical treatments of SUI, abdominal POP repair with mesh,
hernia repair, and other non-urogynecologic indications are not part of this
proposed order.
The FDA will take comments on the proposed order for 90 days.
For
more information:
•
FDA: Proposed Order - “Premarket Approval for
Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair”
The FDA, an agency within
the U.S. Department of Health and Human Services, protects the public health by
assuring the safety, effectiveness, and security of human and veterinary drugs,
vaccines and other biological products for human use, and medical devices. The
agency also is responsible for the safety and security of our nation's food
supply, cosmetics, dietary supplements, products that give off electronic
radiation, and for regulating tobacco products.
# # #
For Immediate Release: April 29, 2014
Media Inquiries: Susan Laine, 301-796-5349, susan.laine@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA, DICE@fda.hhs.gov
Page Last Updated: 04/29/2014
Note: If you
need help accessing information in different file formats, see Instructions for
Downloading Viewers and Players.
No comments:
Post a Comment