Doctor Warns of Continued Harm from Medical Devices if Monitoring is Not ImprovedAug 18, 2015
Dr. Kevin Kavanagh, board chairman of Health Watch USA, an organization that promotes "health care transparency, competition and patient advocacy," warns of the continued harm to patients because there is little effective post-market monitoring of medical devices.
Writing in the Lincoln Herald-Leader (Kentucky.com), Kavanagh says patients are not "guinea pigs" in medical-device testing but more often are "sacrificial lambs" to the medical device industry. They are harmed by the devices that are supposed to treat them or sustain life or manage chronic conditions.
In an op-ed piece for the Herald-Leader, Kavanagh writes of a variety of harmful devices. One such device is the power morcellator, a surgical tool that enables hysterectomies and fibroid surgeries to be performed through a small incision. But the morcellator, whose rapidly spinning blades cut tissue into tiny pieces that can be removed through the incision, has been found to spread cancer in a patient’s abdomen. The device has been on the market since the mid-nineties but just last year received an FDA warning label for the cancer risk.
Kavanagh notes the high failure rates for metal-on-metal-hip implant devices and the cases of metal poisoning caused by the devices. He warns about medical endoscopes, devices to examine and sometimes treat internal organs that can spread antibiotic-resistant bacteria. Many patients have experienced painful complications with vaginal mesh implants used to treat pelvic organ prolapse and stress urinary incontinence. "These devices and others have been implanted in hundreds of thousands of people and have caused harm and death in untold numbers," Kavanagh writes.
Kavanagh says no agency in the U.S. is effectively monitoring what happens after devices are implanted in patients. A "safety feedback loop" to spur device improvement and safeguard patients, is all but lacking, according to Kavanagh. The House of Representatives recently passed the 21st Century Cures Act but instead of strengthening medical device oversight, Kavanagh says the act further weakens device-testing requirements.
Kavanagh says that the benefits of many implants are overstated while the risks are underestimated. Before undergoing an implant procedure every patient should ask:
- What is the implant's failure rate?
- How does the tissue react around the implant?
- If the implant fails can it be taken out?
Kavanagh urges patients to check the rates of MRSA (Methicillin-resistant Staphylococcus aureus) and C. Difficile infections at the hospital where they will have the surgery. This information is available on Hospital Compare (https://www.medicare.gov/hospitalcompare/). Patients having a hip or knee implant or a lumbar or cervical spine fusion should check the surgeon's complication rates on ProPublica's Surgeon Scorecard web site: https://projects.propublica.org/surgeons/. After surgery, the patient should comply with all follow-up recommendations, including doctor appointments and any testing to be sure the device is functioning correctly and not causing unwanted side effects.
Many people will have an implant in their lifetime. According the Journal of Patient Safety, over half of all medical hospital inpatients had an implant. "Almost everyone has a stake in health-care policy regarding implants," Kavanagh writes in the Herald-Leader piece. "We all need to encourage Congress to amend the 21st Century Cures Act to assure effective pre-market testing and post-market monitoring of medical devices