In a three year period, the FDA received 163,800 reports of deaths, serious injuries, or malfunctions that were directly related to the use of defective medical devices. Thousands of medical devices are released to the public each year, including orthopedic devices (such as knee and hip replacements), cosmetic implants (such as breast implants), surgical tools, and cardiology equipment (such as pacemakers).
Inadequate Testing Can Lead to Defective Devices
The Food and Drug Administration’s Center for Devices and Radiological Heath (CDRH) is responsible for testing and approving every medical device made available in this country. The CDRH receives adverse reaction reports on thousands of dangerous and defective devices each year, some so unsafe they need to be recalled from the marketplace. Even without causing death, defective medical devices can still cause pain, suffering, and injuries so severe that corrective surgery is required to fix and/or remove the device. Why are so many dangerous or defective medical devices released into the marketplace? The approvals process for medical devices is supposed to be rigorous and thorough, but it has come under investigation as more devices are found to be defective.
The FDA Tries to Appease Manufacturers
The FDA is always under pressure from major manufacturers for faster approvals and a less strict testing process. Also, similar to drugs, not all of the serious adverse reactions caused by medical devices are documented by the time a device is actually marketed. Even devices approved by the FDA can cause severe side effects and injuries that are not found in the testing process. There is also the classic story of corporations putting profits over people. The medical device industry is a multi-billion dollar business, and the competition to bring a new device to market is fierce. Quality control, manufacturing errors, and design flaws can all be ignored in the race to be the first to release a new device. Some companies have gone so far as to hide evidence from the FDA in order to a get a device approved.
Example: Hip Implants
Problems with the metal-on-metal devices – such as hip implants – include loosening, fracturing, and dislocating of the device caused by inflammation in the joint space. We are investigating all cases involving metal-on-metal hip implants, including the DePuy Orthopaedics ASR XL Acetabular System and the DePuy ASR Hip Resurfacing System, recalled in August 2010; the Smith & Nephew R3 Acetabular System recalled in June 2012; the Stryker Rejuvenate and ABG II modular-neck stems recalled in July 2012; the DePuy Pinnacle, the Zimmer Durom Cup, the Wright Conserve, and the Biomet M2A and M2A-Magnum hip replacement systems, which have not been recalled. Reported problems include pain, swelling and problems walking.
Schwartzapfel Lawyers P.C. Can Help
If you or a loved one have experienced any major side effects as a result of a defective medical device, please call us at 1-888-575-6410 or fill out our online contact form for immediate attention to your case. We have extensive experience working with defective device cases, and we will put our expertise and knowledge to work for you, ensuring that you receive the compensation you deserve for injuries that were not your fault. We will fight for you!