Closing Loopholes and Testing Patients

hip joint surgery
Surgeons replace a hip joint.

American and British agencies are taking different tacks at they address issues related to failing medical devices such as hip replacements and plastic surgical mesh.

Hundreds of lawsuits have been filed about these devices. Metal-on-metal hip replacements, intended to relieve pain and increase mobility in patients with hip problems, have had a much higher failure rate than metal and plastic or ceramic implants. Plastic surgical mesh has been used to support weak pelvic muscles, and in many cases, patients reported additional internal injuries, incontinence, and pain.

In the U.S., the Food and Drug Administration’s (FDA) 510(k) approval system for medical devices has come under increased fire as a result. Alex Nussbaum reports for Bloomberg on how the system may be changed:

The Food and Drug Administration’s top medical-device regulator said the agency needs more power to block unsafe products and prevent repeats of faulty hip implants and vaginal mesh that sparked thousands of patient lawsuits.

House Democrats introduced legislation this month to let the FDA reject devices that have designs based on past products that were recalled for safety flaws. The agency now lacks that authority in many cases, creating a ‘loophole’ that’s challenged the credibility of some device approvals, said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.

Nussbaum adds that “Shuren, while not endorsing the bill, said the agency supports a legislative fix,” to make sure that if there is a problem with a new device, it gets addressed before going to market.

The proposed bill has met with resistance from a medical device trade group in Washington, D.C., writes Nussbaum, as the group thinks that more regulation would prolong already the already long timeframe for reviews and that FDA currently has “abundant authority to carry out its mandate.”

In the U.K., medical officials are recommending an extended period of testing to detect failure. Fergus Walsh reports for BBC News:

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued new advice saying patients with these large head [36-mm or more] diameter metal-on-metal hips will need monitoring for the life-time of the implant. At present the monitoring stops after five years if the patient has no adverse symptoms.

In future patients will continue to have annual blood tests to check for the level of metal ions — a high level can be indicative of tissue damage around the hip which — left untreated — could make replacement more difficult. If the [microscopic metal] ion levels [generated from wearing joints] are rising then patients will be given an MRI scan to check for damage.

Source: “FDA Device Chief Says Approval ‘Loophole’ Needs to Be Closed,” Bloomberg, 2/28/12
Source: “Annual checks for patients with all-metal hips,” BBC News, 2/28/12
Image from Wikimedia Commons, used under Fair Use: Reporting.

Rachel Petkewich is a freelance science writer and editor. She has worked as a research scientist in the chemical industry and spent eight years as a staff writer and editor at various science journals and magazines, including Chemical & Engineering News.

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