(PRWEB) February 09, 2012
New developments are emerging out of Washington, D.C., on mounting complaints surrounding medical product recalls. Parker McDonald P.C. represents victims of defective medical devices, and new legislation may be on the way to keep these products from reaching the market.
A recent Bloomberg article, reported today that House Democrats are pushing to close a loophole in the medical device approval process. Representative Edward Markey of Massachusetts is leading the bill to prevent manufacturers from receiving medical device approval when a new product is similar to one already taken from the market.
Companies rely heavily on the FDA’s 510(k) process to ensure that their product will hit the market as soon as possible without the costs of conducting clinical trials. This fast-paced approach used by manufacturers has come under review in recent years.
Transvaginal mesh is the most recent product to draw scrutiny. The number of complaints received by the FDA has increased in the past few years. In July of last year, the FDA issued a safety alert to inform the public that serious complications associated with transvaginal surgical mesh to treat pelvic organ prolapse or stress urinary incontinence are not rare. Just last month, the FDA ordered manufactures to perform more conclusive studies on the safety levels of their surgical mesh implants.
According to a recent report by Bloomberg, the FDA continued to approve transvaginal mesh devices made by Johnson & Johnson and other health-care companies based on their similarity to a Boston Scientific device that had been pulled from the market due to safety complaints. Representative Markey’s bill seeks to eliminate this characteristic of the 510(k) process by ensuring “that devices do not mimic the mistakes made by other products.”
The potential impact of this bill may be felt by both manufacturers and patients if it gains the support of Congress and the White House. With ongoing litigation in several states concerning allegedly defective DePuy hip implants, which were approved through the 510(k) process, manufacturers could be facing a wave of reforms on top of financial payouts.
Parker McDonald will continue to monitor this situation as well as the recall status of vaginal mesh implants. If you are a victim of a defective medical device, visit parkermcdonaldlaw.com or contact us at 800-990-4884.
About Parker McDonald
Parker McDonald, P.C. offers comprehensive legal services for clients whose personal, business or property rights have been adversely affected. Built on years of trial experience, Parker McDonald lawyers are dedicated to a tradition of personal service and timely delivery of outstanding results. Parker McDonald has offices in Bedford, Fort Worth, Houston, Austin, and San Antonio.