Surgeons perform nearly 250,000 hip replacements every year. It is a common procedure that often leads to significant relief for patients who have experienced the pain and stiffness associated with deteriorating hips. However, after a recent FDA mandate, many surgeons are reconsidering the medical devices they use.
The Food and Drug Administration (FDA) was created to function as a consumer protection agency, though it did not assume its current name until 1930. With the passage of the 1906 Pure Food and Drugs Act, the FDA assumed regulatory functions. In this capacity, it oversees the manufacturing, marketing and distribution of medical products such as these approved hip-replacement devices:
- Metal-on-polyethylene
- Ceramic-on-polyethylene
- Ceramic-on-ceramic
- Metal-on-metal
Until recently, nearly one-third of the total hip replacement surgeries every year used metal-on-metal devices. However, after increasing reports of problems, Johnson & Johnson recalled its Articular Surface Replacement (ASR) in 2010. Yet, the complaints against other metal-on-metal devices continued to roll in.
Since January 2011, the FDA has received nearly 5,000 complaints of malfunctioning metal-on-metal hips: more than the combined total of complaints filed over the previous four years. In comparison, 7,700 complaints were filed in relation to the 2007 Medtronic recall of a heart device component. With the significant increase in all-metal hip-related complaints, many experts believe the device may lead to the next major medical implant problem.
At issue are the health problems experienced by patients who had metal-on-metal hip replacements. Through standard wear, metallic shavings of cobalt and chromium enter the body and embed in tissue. Researchers are studying the effects of the metal debris on the human body, but many patients attest to developing rashes, pain and inflammation.
Because the FDA regulations do not always require testing in patients and tracking device performance, many products enter the market without manufacturers or regulators knowing how the devices will perform long-term or the side effects that may manifest from use. Such has been the case with the metal-on-metal hips, but no more.
Responding to the deluge of complaints, in May 2011 the FDA began requiring all-metal hip producers to study the devices' failure rates and the threat they pose to patients. Unfortunately, following the FDA order has proven to be difficult for producers since companies did not keep patient registries. To identify and recruit qualified patients to participate in their studies, some producers are turning to health systems and hospitals that have operated and maintained their own registries.
Producers must submit study proposals to the FDA, and the agency has until November 2011 to determine if the plans are adequate. With no independent research being conducted, one California product liability lawyer and other skeptics have questioned the validity of the studies proposed by producers with financial interests in the outcome.
Dr. William Maisel, former chair of the FDA's Heart Device and Post Market Advisory panels and founder and director of the Medical Device Safety Institute, believes the producers' studies will be vigorous and thorough. However, he also believes the findings and subsequent evaluation of patient safety could take several years.
