In an article published by the Lexington Herald-Leader, a Kentucky physician calls for greater regulation of medical devices. Dr. Kevin Kavanagh of Somerset, Kentucky, who is also board chairman of Health Watch USA, writes that patients will continue to be harmed by medical devices unless more monitoring is implemented. “…we are not even guinea pigs, we are sacrificial lambs for corporate profits.” Dr. Kavanagh writes.
The article notes that there is inadequate post-market monitoring for medical devices once they are on the market and cites examples of products that have come under scrutiny due to safety issues. Power morcellators, for instance, have been on the market since 1994. Only recently has the FDA publicly identified a risk of cancer spread by the tools, which cut up tissue into tiny pieces for easier removal through small incisions. Metal-on-metal hip implants have been found to fail at high rates and cause metal poisoning. When these hip replacements were first introduced, they were touted as being more durable and better suited for younger, more active patients. Transvaginal mesh implants have been linked to numerous injury reports and retrograde medical endoscopes have recently been found to spread antibiotic-resistant bacteria.
Dr. Kavanagh writes that “These devices and others have been implanted in hundreds of thousands of people and have caused harm and death in untold numbers.” Since there is no adequate system in place to monitor the devices after they are implanted in patients, the true number of people harmed by faulty devices is unknown. The article notes that metal-on-metal hip issus were identified in England, where an effective reporting registry is in place.
Medical device monitoring is especially relevant in light of the 21st Century Cures Act, which was passed by the House of Representatives in May. The bill, which aims to speed approval of drugs and medical devices, lowers requirements for testing.