The Food and Drug Administration (or FDA) is responsible for regulating the safety of drugs and medical devices. The Medical Device Reporting Regulation (MDR) requires manufacturers of medical devices to report deaths, injuries, and malfunctions directly to the FDA. Also, hospitals and other facilities are required to report medical device-related deaths both to the manufacturer and the FDA. The MDR has received numerous reports of injuries from medical devices.
For instance, there have been reported problems with Transvaginal Mesh mainly used for the treatment of pelvic organ prolapse and incontinence. Injuries may vary depending on the type of mesh used. The more common injuries include pelvic pain, Infection, urinary problems, injury to nearby organs. It is extremely important that a claimant seek legal counsel if they are injured by a defective medical device. Counsel must first determine the type and manufacturer of the product.
Other medical device problems have been documented in the areas of knee replacement and hip replacement devices. DePuy Orthopedics issued a recall for its metal on metal hip replacement prosthetic device. The lawsuits include claims for failing to warn the physicians and patients of the problems with their device. The problems include pain, popping, grinding, metal sensitivity, infection and other symptoms.
Reported injuries and problems have also occurred with the Zimmer NexGen CR- flex knee replacement. Patients have reported losing their Zimmer knee replacement which causes severe pain, swelling and difficulty walking. Patients may require removal surgery due to these severe problems.
Gerald R Stahl is a Fellow in The National College of Advocacy representing victims of injuries throughout Michigan and other States. If you have been diagnosed with a problem related to a faulty medical device liability or a defective drug, Gerald R. Stahl’s 30 years of experience in Michigan and other states can go to work for you. In a personal injury case, Gerald R Stahl does not charge a fee unless the client recovers money damages. Gerald R Stahl is conveniently located on East Beltline near Knapp’s Corner and the 63rd District Court.