An influential health insurer trade group has called for more stringent rules related to the approval and tracking of medical devices. The request follows revelations of gaps or loopholes in the federal regulatory procedures which allow potentially dangerous medical devices to be put on the market with minimal safety and performance testing.
It has been several years since Michigan-based medical device manufacturer Stryker issued a voluntary recall of their Rejuvenate and ABH II modular-neck stem metal hip replacements, according to the U.S. Food and Drug Administration. The recall was made after many patients complained that the hip replacement was defective, causing them more pain and suffering than before the implant was surgically inserted.
A recent report shows the number of recalled medical devices continuing to increase. In response, many watchdog and consumer protection groups are aiming to make stricter requirements for medical devices.
Heart surgery and the implementation of a heart device are very serious procedures. According to the New York University Langone Medical Center coronary revascularization is one of the most risky heart procedures for patients; however, it is recommended for heart failure patients who have a varying degree of severity of heart problems.
Drug companies have attempted to capitalize on a market of men interested in improving their libido and life satisfaction with a treatment known as Low-T testosterone therapy. But that treatment is raising eyebrows from the FDA.
The total number of defective medical device recalls in the past decade represents a significant increase, and it raises the question of whether more people are reporting issues or if there are simply more design defects putting patients at risk. Defective devices can injure patients and cause serious physical and mental repercussions when the device does not operate properly.
The FDA recently launched a comprehensive investigation into the “low T” testosterone therapy program. Early research indicates that men may face a higher risk of premature death, stroke, or heart attacks by undergoing this therapy.
A new report from the Food & Drug Administration’s Center for Devices and Radiological Health says that defective devices have spiraled out of control in the last decade. Between 2003 and 2012, device recalls have increased by 97 percent. Defective medical devices have caused injuries, pain, and complications for patients who use them.
In recent months, the FDA has begun reviewing more information regarding Essure, a transcervical sterilization procedure for women. Essure is a Class III medical device that, according to the FDA, received a high level of review prior to marketing. The procedure had to be vetted through the pre-market approval process used by the FDA. This process includes reviewing data about product labeling materials and a scientific and regulatory review.