By Cesar Pinto
The Philadelphia product liability lawyers at Messa & Associates discovered a recent investigation released by Consumer Reports revealing that many medical device implants are sold with little safety testing, or no testing at all. This report raises concerns for the safety of the millions of Americans living with implantable medical devices in their bodies.
Under the current regulatory system, the manufacturers of a medical device simply pay a user fee of $4,000 and submit some required paperwork to the Food and Drug Administration (FDA). The manufacturers are then allowed to sell their product. The investigation by Consumer Reports included an analysis of medical research and the FDA’s device-safety database. Interviews with patients and doctors were also conducted. The report raised several areas of concern.
The first finding revealed is that medical devices are often not tested before they are released and sold on the market. Essentially, without knowing it, patients that have a medical device implanted in them are helping to test the product. Most likely, these people believe that the safety and effectiveness of the product had been tested beforehand. Secondly, there is not a systematic process in place for the government or medical researchers to identify and explore problematic issues with a device. Each implantable device does not have a unique serial number. This makes it difficult for patients to be notified if a problem is identified. Lastly, patients are left with limited abilities to protect themselves unless changes are made to the current system of regulating medical devices.
Metal Hip Implants: The FDA approved an artificial hip manufactured by DePuy without any clinical testing. It was cleared through the agency’s policy on “substantial equivalence” meaning that this hip device was considered the same as and as safe as an earlier device. These metal-on-metal hip implant devices began to fail at a significant rate within a few years rather than lasting the expected 15 years. Crippling and debilitating injuries were reported as well as high levels of metal ions being detected in patient’s blood. A worldwide recall had to be issued causing many patients to undergo revision surgeries.
Surgical Mesh: Transvaginal mesh implants were used on hundreds of thousands of women having to undergo prolapse repair and bladder support surgery since the early 2000s. Cases of adverse health consequences have been reported and multiple lawsuits have been filed. A loophole in the law allowed this product to be grandfathered in without the need for any safety testing.
Lap-Bands: Implantable lap-bands are utilized in patients struggling with obesity. The product, which is manufactured and sold by Allergan, helps to constrict the size of the stomach thereby restricting the amount of food the stomach can hold at one time. Over time, weight loss can be achieved. These products generally require advanced safety testing in order to obtain approval from the FDA. In this specific case, the lap-band was granted approval after only one clinical trial. The study included 299 participants in whom 51 percent stated they had experienced nausea, vomiting, or both. In addition, 25 percent of the study participants had to have the bands removed prior to the end of the three-year study due to complications or the failure to lose weight.
Cardiac Devices: The three cardiac devices that were discovered to have significant problems are implantable cardioverter-defibrillators, vena cava filters, and automated external defibrillators. More than 29,000 deaths and injuries have been reported to the FDA in association with these medical devices.
Since nearly 17% of American adults report having some type of implanted medical device, the concerns about the safety of these devices and the adequacy of the approval process overseen by the FDA is alarming. Consumers Union, which is the advocacy arm of Consumer Reports, believes that the medical device regulatory system that is in place does not protect patients from harm. This group has recommended several changes to both the FDA and Congress. It is recommended that implants and other medical devices should have to undergo the same rigorous testing that prescription drugs do. The practice of grandfathering new implants and devices should be banned. A “unique identifier system” similar to a serial number should be created so that patients could be notified when any recalls or safety issues arise as well as the creation of a national registry. Finally, it was suggested that the manufacturer user fees be increased allowing the FDA to have additional financial funds to carry out their duties.
The product liability lawyers at Messa & Associates are appalled at the recent healthcare findings of the Consumer Reports investigation that American patient’s lives are in jeopardy when they have a medical device implanted in their bodies. We support the initiatives outlined by the Consumers Union, and believe that the manufacturers of these defective and dangerous medical devices need to be held accountable. Our Philadelphia product liability attorneys are experienced at handling claims involving defective medical devices, and our extremely skilled team of personal injury lawyers and medical experts are dedicated to ensuring you receive proper compensation for your injuries. We are committed to protecting the legal rights of those adversely affected by defective medical devices and dangerous pharmaceuticals. If you believe that you or a loved one has been harmed by the implantation of a dangerous or defective medical device, contact our Philadelphia product liability attorneys for a free consultation. Call Messa & Associates at 1-877-637-7252 or submit a free online inquiry.