surgical mesh

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FDA Proposes Tougher Rules For Surgical Mesh

The U.S. Food and Drug Administration is proposing tougher regulations for vaginally implanted surgical mesh to treat women with prolapse, The Wall Street Journal reports.

In a document posted to FDA’s website Thursday the agency said, the “rate and severity of mesh-specific adverse events following vaginal POP [pelvic organ prolapse] repair with mesh calls into question the safety of these devices.” Many side effects were caused by the mesh protruding out of the vaginal tissue, which in turn caused pain, infection and bleeding.

The agency said is proposing new mesh products undergo a premarket review process, which requires companies to conduct studies looking at a product’s safety and effectiveness prior to approval. The mesh products are currently reviewed under the less stringent review known as the 510(k) process. The agency is also proposing that studies involving current products be conducted but said it would consider a grace period for companies to submit a premarket approval applications.

An FDA advisory panel is being called on to discuss the mesh products next week. The meeting [Sept.8-9] is expected to mostly focus on mesh when used to treat organ prolapse, but the panel will be asked to discuss the use in treating a condition known as stress urinary incontinence. The consumer group Public Citizen petitioned the FDA last week to recall existing mesh products and require new products to undergo a premarket review process.

In a piece yesterday, I wrote about a group of pelvic surgeons who are challenging some of the FDA’s safety warnings.

Medical Device (Adverse Event) Reports

Surgeons Challenge FDA Warnings On Vaginal Mesh

The debate over a controversial medical device used for women is heating up.

A nationwide coalition of pelvic surgeons is challenging a recent U.S. Food and Drug Administration safety advisory that warns of serious risks, complications and questionable benefits of surgical mesh implanted vaginally to treat women for a condition known as prolapse. The procedure is used to strengthen vaginal tissue that has grown weak or stretched, often after childbirth.

In advance of an FDA advisory panel meeting Sept 8-9 to discuss the safety and effectiveness of the mesh — and as attorneys across the country intensify their efforts targeting the device through litigation — pelvic surgeons say they e-mailed a response letter to the FDA outlining their concerns. A copy of the letter was obtained by CommonHealth.

“We have some significant disagreement with the conclusions reached [by The FDA] and concerns regarding the message that it is sending to our patients, the healthcare community, and unfortunately to the legal community as well,” says the Aug. 25 letter, which is signed by more than 600 pelvic surgeons, according to one of the organizers, Dr. Miles Murphy, associate medical director at the Institute for Female Pelvic Medicine & Reconstructive Surgery and Director of the Division of urogynecology at Abington Memorial Hospital in Pennsylvania. Continue reading