By Shirley S. Wang Surgical mesh kits used to repair a condition called pelvic organ prolapse should be more closely regulated, the Food and Drug Administration announced on Tuesday, signaling heightened recognition of the safety issues associated with the devices currently on the market.
The FDA's proposed changes, if finalized, would reclassify the medical devices as high risk instead of moderate risk, and would be significant because companies would have to submit safety data even of existing devices to keep them on the market.
Many of the currently available kits were approved through what is known as the 510(k) process. This expedited review allows for a device that is substantially similar to ones already on the market to be approved without demonstrating independent safety data for the new product. The 510(k) process has been widely criticized for allowing some new devices to come to market too easily and without proper safety testing.
"For the vast majority of products cleared through the 510(k) process, it's an effective, efficient and scientifically valid way for assessing a product," said William Maisel, deputy director of science and chief scientist at the FDA's Center for Devices and Radiological Health.
Since 2008, the FDA has been looking into cases of serious complications associated with the transvaginal mesh kits used to treat prolapse and urinary incontinence. Such complications include shrinking and movement of the mesh from its original location, sometimes causing significant and chronic pain. The kits also are the subject of thousands of product-liability lawsuits by women who say that they were injured when the procedure failed.
"The most important message is we don't believe evidence of effectiveness has been demonstrated of transvaginal mesh for pelvic organ prolapse repair," said Dr. Maisel.
The proposed changes announced Tuesday pertain to the kits used to treat prolapse, not urinary incontinence. There are some differences between the kits, such as the shape of the mesh, but moreover the evidence supports the use of the kits to treat incontinence, according to Dr. Maisel.
Makers of mesh kits include Johnson & Johnson's Ethicon unit and Boston Scientific Corp. J&J said it no longer has any products on the market that would be affected by the new recommendation.
"Ethicon remains committed to advancing the standard of care for women's health and will continue to offer safe and effective treatment options for women suffering from pelvic disorders," J&J said in a statement.
Boston Scientific said in a statement that it is "dedicated to delivering safe, high quality products for women with pelvic floor disorders" and is "continuing to work with the U.S. Food and Drug Administration to ensure appropriate information regarding mesh products is provided to patients and doctors."
With the transvaginal mesh procedure, mesh is designed to be inserted through the vagina to repair prolapse by propping up internal organs that have "fallen" into the vagina. About 75,000 transvaginal mesh procedures for prolapse were performed in 2010, according to the FDA.
Write to Shirley S. Wang at shirley.wang@wsj.com
The FDA's proposed changes, if finalized, would reclassify the medical devices as high risk instead of moderate risk, and would be significant because companies would have to submit safety data even of existing devices to keep them on the market.
Many of the currently available kits were approved through what is known as the 510(k) process. This expedited review allows for a device that is substantially similar to ones already on the market to be approved without demonstrating independent safety data for the new product. The 510(k) process has been widely criticized for allowing some new devices to come to market too easily and without proper safety testing.
"For the vast majority of products cleared through the 510(k) process, it's an effective, efficient and scientifically valid way for assessing a product," said William Maisel, deputy director of science and chief scientist at the FDA's Center for Devices and Radiological Health.
Since 2008, the FDA has been looking into cases of serious complications associated with the transvaginal mesh kits used to treat prolapse and urinary incontinence. Such complications include shrinking and movement of the mesh from its original location, sometimes causing significant and chronic pain. The kits also are the subject of thousands of product-liability lawsuits by women who say that they were injured when the procedure failed.
"The most important message is we don't believe evidence of effectiveness has been demonstrated of transvaginal mesh for pelvic organ prolapse repair," said Dr. Maisel.
The proposed changes announced Tuesday pertain to the kits used to treat prolapse, not urinary incontinence. There are some differences between the kits, such as the shape of the mesh, but moreover the evidence supports the use of the kits to treat incontinence, according to Dr. Maisel.
Makers of mesh kits include Johnson & Johnson's Ethicon unit and Boston Scientific Corp. J&J said it no longer has any products on the market that would be affected by the new recommendation.
"Ethicon remains committed to advancing the standard of care for women's health and will continue to offer safe and effective treatment options for women suffering from pelvic disorders," J&J said in a statement.
Boston Scientific said in a statement that it is "dedicated to delivering safe, high quality products for women with pelvic floor disorders" and is "continuing to work with the U.S. Food and Drug Administration to ensure appropriate information regarding mesh products is provided to patients and doctors."
With the transvaginal mesh procedure, mesh is designed to be inserted through the vagina to repair prolapse by propping up internal organs that have "fallen" into the vagina. About 75,000 transvaginal mesh procedures for prolapse were performed in 2010, according to the FDA.
Write to Shirley S. Wang at shirley.wang@wsj.com
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