FDA: *IMPORTANT* How To Weigh in on Reclassifying Pelvic Mesh To High-Risk!
*NEW* Readers of Mesh News Desk understand that the Food and Drug Administration has allowed the polypropylene-based material onto the market to treat pelvic organ prolapse and incontinence with very little scrutiny. In fact, the 510(k) approval process is an approval to sell, and does not require safety and efficacy assurances.
Now the agency is proposing reclassifying pelvic mesh from Class II (moderate risk) to a high-risk Class III which would require Premarket Approval and clinical trials for safety and efficacy! This was initially suggested in an FDA White Paper issued in August 2011. See back story here.
But this is the first time a formal proposal will allow Americans to weigh in. What’s significant is the presumption if pelvic mesh had been tested prior to being marketed it would never have been sold. The comment period will last 90 days only and industry and lobbyists who oppose the reclassification will
What is prompting this proposal? The agency has received 20,000 additional adverse events reports from from 2011 to 2013, according to Susan Laine of the Press Office to MND.
THIS INVOLVES MESH FOR POP (pelvic organ prolapse) NOT SUI (stress urinary incontinence!
Citizens can make their voices heard over the next 90 days about this important issue. Should a medical device that is intended to be permanently implanted not undergo clinical trials required under Premarket Approval? Please let the FDA know what you think. May 1 the link will be established to let you weigh in. Here is the Federal Register Post. Submissions will be taken starting May 1.
From: FDA Office of Media Affairs <FDAOMA@FDA.HHS.GOV>
Date: April 29, 2014 at 9:54:54 AM EDT
Subject: FDA issues proposals to address risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse
Reply-To: FDA Office of Media Affairs <FDAOMA@FDA.HHS.GOV
“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 assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair.” provide premarket clinical data to demonstrate a reasonable
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.”
Here is the Federal Register that walks you through the submission comment which begins May 1, 2014 for 90 days. I seriously urge you to let this agency know your thoughts including those of you with mesh for incontinence which this proposal does not address! Here is a direct link. Thank you.
Enter your comments into the Federal Register for Reclassification – HERE!
The FDA had in January 2012 ordered mesh manufacturers to study complications in women with implants. Those results should be available in January 2015 if the studies got started on time. They did not. Here is a background story:
August 2011, FDA considers changing mesh classification.