(PRWEB) March 27, 2012
Parker McDonald, P.C. is alarmed by a recent Bloomberg report that healthcare giant Johnson & Johnson sold a vaginal mesh implant for three years before it received U.S. approval from the Food and Drug Administration. According to Bloomberg, the Gynecare Prolift device was introduced by Ethicon, a subsidiary of Johnson & Johnson, in March 2005.
In the Bloomberg article it is noted that the FDA released a statement claiming that it did not learn of the Prolift device until 2007 when the company sought approval for a similar mesh implant. Ethicon said it could market the Prolift without approval because of its similarity to a previously approved implant, the Gynecare Gynemesh. Bloomberg reported that Morgan Liscinsky, a spokeswoman for the FDA, said the “FDA disagreed with this assertion,” and concluded that distribution began “without appropriate” clearance. The Prolift was cleared by the FDA in May 2008.
Bloomberg reported that “a review of an FDA database of reported malfunctions, deaths or serious injuries shows the agency got 123 complaints about Prolift from 2005 to May 15, 2008, when the device won clearance.”
Ethicon’s conduct raises questions about the FDA’s controversial 510(k) clearance process. Companies rely heavily on the 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 2011, the FDA issued a safety alert to inform the public that serious complications are associated with transvaginal surgical mesh. In January the FDA ordered manufacturers to perform more conclusive studies on the safety levels of their surgical mesh implants.
Parker McDonald currently represents clients who have undergone surgery to receive transvaginal mesh. The firm will continue to monitor updates as well as the recall status of vaginal mesh implants. If you are a victim of a defective medical device, visit http://www.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.