Report Raises Concerns Over Medical Device Safety
According to information recently released by Consumer Reports, medical devices like internal defibrillators and artificial joints routinely enter the marketplace without undergoing safety testing. According to the report, more than 90 percent of medical devices are made available for distribution without first undergoing testing to ensure their safety, often on the basis of the manufacturer’s claims that the new device is substantially similar to a product already available in the marketplace.
Unfortunately, many untested devices ultimately prove dangerous, and patients are often unaware of the risks until they have already had these defective products implanted in their bodies.
In its investigation, Consumer Reports studied the risks associated with four common medical implants:
- Surgical mesh: Often used to treat women’s urinary incontinence and pelvic organ prolapse after childbirth, vaginal surgical mesh implants have been implicated in thousands of reports of injuries and other adverse events. The implants did not undergo safety testing before entering the marketplace.
- Lap-Band gastric devices: Lap-Band adjustable gastric bands were made available as a surgical treatment for obesity after minimal testing in a study involving just 299 participants, according to Consumer Reports. Of those, more than half complained of nausea or vomiting or both, and one in four had the device removed before the end of the study. The Lap-Band device has reportedly been linked to several deaths and other serious complications.
- Metal-on-metal hip replacements: Although once touted as a major improvement over artificial hips made from other materials such as plastic and ceramic, all-metal hip implants have been called “one of the biggest disasters in orthopedic history” by the British Medical Journal. The devices have been found to fail more often than traditional models and can cause serious health problems including metal poisoning and tissue deterioration.
- Cardiac devices: The investigation by Consumer Reports covered three types of cardiac devices, including implantable cardioverter-defibrillators, which the report says have been responsible for nearly 29,000 deaths and injuries since 2009. Almost 350,000 of the devices have been recalled for faulty wiring after being implanted in patients.
In 2011, a panel from the Institute of Medicine recommended an overhaul of the FDA’s medical device regulatory system, claiming that the current system does not adequately protect patients from being harmed by dangerous medical devices. Patients who are injured or become ill because of a defective medical device may be able to receive financial compensation for their losses. For more information about seeking compensation for a medical injury, contact an experienced products liability lawyer.