FDA Planning Tougher Regulations For Surgical Mesh
In a document posted to FDA's website Thursday the agency said, the "rate and severity of mesh-specific adverse events following vaginal POP 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 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.
The mesh products are made by at least nine companies.
"For women suffering from pelvic organ prolapse or stress urinary incontinence, surgical intervention and the use of mesh is an important treatment option," says Wanda Moebius, spokeswoman for AdvaMed, a Washington trade group representing medical device makers. "The use of surgical mesh has an established track record and the 510(k) process has enabled great learning and medical advances in this field." Both Boston Scientific and Johnson & Johnson's Ethicon unit, which makes the mesh, also said they would continue to work with FDA on the matter.
In July the FDA issued a safety communication warning health care providers and patients that surgical placement of mesh through the vagina to repair pelvic organ prolapse could expose patients to greater risk than other surgical options to fix sagging organs. The condition occurs when the internal structures that support the pelvic organs such as the bladder, uterus and bowel, become so weak or stretched that the organs drop from their normal position and bulge or prolapse into the vagina.
FDA said surgery to repair POP can be performed through the abdomen or transvaginally, through the vagina, using stitches, or with the addition of surgical mesh to reinforce the repair and correct the anatomy. The agency said there were about 75,000 transvaginal procedures that used surgical mesh. From 2008 to 2010, the FDA received 1503 adverse event reports associated with mesh used for POP repair, which was five times as many as the agency received from 2005 to 2007.