Transvaginal Mesh Review May Revoke FDA Approval
The U.S. Food and Drug Administration has issued a report announcing their recommendation that transvaginal mesh devices be re-classified as a high risk medical device, according to news sources. The FDA is requiring new safety statistics be submitted by the manufacturer in order for the product to remain on the market.
A panel will meet next week to decide if the reclassification for the device, which is used for pelvic organ prolapsed and stress urinary incontinence.
While currently classified as “moderate risk,” the FDA has issued three separate warnings since 2008 after thousands of complaints were received as well as reports of fatalities. The FDA has also stated that the mesh does not provide more benefits than surgery.
Complications include mesh erosion, infection, pain, dyspareunia, vaginal scarring, urinary retention or urinary incontinence, and recurrence of POP and/or SUI.
As a Los Angeles product defect lawyer, I hope the FDA can make a recommendation that is in the best interest of the patient. A patient has the right to be informed of the risk they are undergoing when they choose to utilize any medical device. If you’ve been injured by a medical device, it’s important to contact a personal injury lawyer as soon as possible because you may be entitled to monetary compensation as a result of getting injured because of a defective or recalled product. The longer you take to contact someone, the more evidence is lost.