The number of complaints involving failed hip replacements has been on the rise. In fact, according to The New York Times, the U.S. Food and Drug Administration (FDA) has received more than 5,000 complaints regarding failed hip implants since January. This, according to The New York Times, is more than the agency has received in the last four years combined.
The majority of the complaints are coming from patients who have received metal-on-metal implants. The all-metal hip systems are made completely of metals such as titanium, stainless steel and cobalt chromium.
The complaints have come from patients who have either had their hip implants surgically removed or those who require revision surgery to replace a failed implant. Hip implants are supposed to last at least 15 years, but some patients have experienced failures in as few as five years.
DePuy Orthopaedics, a Johnson & Johnson company, recalled two metal-on-metal hip replacement systems last year, due to a high failure rate. The ASR™ XL Acetabular System (sold worldwide) and the ASR™ Hip Resurfacing System (sold only outside the U.S.) were reported to have a 12 to 13 percent failure rate within five years of implantation, according to the recall.
In addition to early failure rates, all-metal hip systems have been known to shed small pieces of metal into patients’ bodies as the metal components rub against each other. The metal particles can lead to serious injuries.
Overtime, the metal particles can build up around the joint and cause irritation and inflammation that could cause the implant to loosen. When an implant becomes loose, the patient will require surgery to fix the problem.
Patients are also at risk of suffering serious injuries to the heart, nervous system and thyroid gland if the metal particles get into their bloodstream.
Because of the potential risks, the FDA ordered 21 makers of metal hip implants to conduct safety reviews of their products. The agency seeks to determine the exact risks associated with all-metal hip replacements.
In the meantime, however, patients continue to report problems with the hip systems and the complaints continue to stack up. Researchers now are trying to figure out the tissue damage caused by the metal debris and surgeons are reluctant to use all-metal hip systems until further information is available.
Use of all-metal hip systems has dropped to about 5 percent of the market, although some patients have not experienced pain or problems with their replacements, according to the New York Times.
“It is like playing Russian roulette,” said Dr. Geoffrey H. Westrich, an orthopedic surgeon at the Hospital for Special Surgery in New York, who has stopped using all-metal implants.
According to The New York Times, this could be the biggest and most costly medical implant problem since Medtronic recalled one of its heart device components in 2007.