According to Consumer Reports, most medical implant devices are not tested for effectiveness and safety before being allowed into the marketplace. In many cases, manufacturers pay just a $4,000 user fee and submit the required paperwork to the US Food and Drug Administration. Often, it isn’t until patients actually use them that these devices are “tested.” Even the advance safety studies for many high-risk products are a lot less stringent than the ones conducted on prescription medications.
Our Charlotte, North Carolina personal injury law firm represents patients that have suffered serious complications because of dangerous drugs and defective medical devices. Manufacturers should be held liable and we are committed to making sure that this happens.
While the FDA believes that its current device regulatory system works in terms of ensuring patient safety, the Consumer Reports, which conducted an investigation into this matter is not so sure. Following an analysis of medical research and the FDA’s device-safety database, as well as interviews with patients and doctors, a number of findings were reached, including the discovery that the government and researchers don’t have a systematic way at their disposal to identify medical device problems. If you think about how many consumer products have unique serial numbers that allow manufactures to notify owners when there is a problem, but not a medical device such as an artificial heart valve does not, this is obviously a serious disparity and a problem for patients.
Among the different medical devices that have recently been in the media spotlight following reports of related injuries and health complications:
Metal Hip Implants: Our Charlotte, North Carolina defective medial device law firm has been fielding calls from people that suffered complications because their metal hip implant devices failed (requiring them to undergo revision surgery sooner than should have been necessary) or metal bits of the device broke off in their bodies. Already there have been over 5,000 hip implant lawsuits filed in the US.
Lap-Bands: These implanted bands are popular among people needing them for health reasons and those that want to lose weight and keep it off. Lap-Bands make the stomach smaller so it is harder to eat large amounts of food. Over 650,000 have been sold around the world. While Lap-Bands have had to undergo advance testing before being allowed into the marketplace, testing for prescription drugs is still tougher. Also, there have been a number of reports of health complications and deaths related to Lap-Band implants.
Transvaginal Mesh: More than 650 vaginal mesh lawsuits have been filed against device manufacturers. Bleeding, pain during intercourse, pelvic perforation, perineal cellulitis, urinary tract erosion, and organ perforation are just some of the complications linked to this medical device implant.
Contact our Charlotte, North Carolina products liability lawyers to request your free case evaluation.
CR Investigates: Dangerous Medical Devices, Consumer Reports, May 2012
Investigation: Most Medical Devices Implanted in Patients without Testing, CBS News, March 28, 2012
Plaintiffs Allege ‘Gruesome Conditions’ at Lap-Band Clinics, Los Angeles Times, January 17, 2012
More Blog Posts:
North Carolina Defective Medical Device?: FDA Warns of Serious Complications from Using Transvaginal Mesh to Repair Pelvic Problems, North Carolina Injury Lawyer Blog, July 27, 2011
Approximately 1,000 DePuy Hip Lawsuits Already Filed Against Johnson & Johnson, North Carolina Injury Lawyer Blog, July 7, 2011
Protecting Americans from Defective Medical Devices: Is the FDA Doing Enough?, North Carolina Injury Lawyer Blog, February 18, 2011