Metal-on-Metal Hip Complaints Filed by Nearly 17K With FDA

Federal regulators have received about 16,800 complaints involving metal-on-metal hip replacement systems since 2000, most of those occurring over the last couple of years. 

According to a report by Bloomberg News, the FDA has seen adverse event reports involving metal-on-metal hip implants skyrocket. While there were only 682 reports filed in 2008, which was four times as many as the year before, there were a staggering 12,137 such reports involving complications from metal-on-metal hip replacements last year.

More than 14,000 of the metal-on-metal hip complaints filed over the last decade involved individuals who required revision surgery to remove the implant.

To make matters worse, it is generally believed that adverse event reports submitted to the FDA only reflect 1% to 10% of all problems actually experienced in the United States, which suggests that hundreds of thousands of people have likely experienced problems.

Concerns about metal-on-metal hip replacements have increased in recent years, amid reports that suggest they may be prone to early failure within a few years. As the metal parts rub against each other, microscopic shavings of metal may be released in to the body, which may cause the implants to loosen or fail.

Awareness of the issues increased following a DePuy ASR hip recall issued in August 2010, impacting more than 93,000 metal-on-metal hip systems sold worldwide. The recall was issued after data suggested that as many as one out of every 8 DePuy ASR implants may fail within five years of surgery.

The information on complaints to the FDA over metal-on-metal hip replacements was reported in advance of next week’s advisory committee meeting, which the FDA scheduled to review the risks and benefits of metal-on-metal replacement systems.

The FDA’s Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee is charged with discussing failure rates, testing for metal ion blood poisoning (known as metallosis), imaging methods, local and systemic complications, patient risk factors and considerations for follow-up after surgery. The committee will then make recommendations to the FDA on how to proceed. The agency notes that it is considering whether to make metal-on-metal hip systems “subject to more rigorous testing and premarket review requirements.”

While the recommendations of the committee are not binding on the FDA, they usually factor significantly in the any final decisions made by the agency.

Over the past decade, metal-on-metal hip replacements quickly grew in popularity, capturing an estimated 30% of the artificial hip implant market in the United States at one time. The widespread use was a direct result of aggressive marketing by the manufacturers, which promoted the all-metal implants as stronger and more durable.

Since the DePuy hip recall and growing concern over the safety of metal-on-metal hip implants, use of the design has fallen sharply. However, concerns remain for individuals who had one of the metal-on-metal hips implanted into their body.

Approximately 6,000 individuals throughout the U.S. have already filed a DePuy ASR hip lawsuit against Johnson & Johnson and DePuy, alleging that the company failed to adequately research the design of their implant or warn about the risk of metal-on-metal hip poisoning.

In addition, hundreds of individuals are currently pursuing a DePuy Pinnacle lawsuit, after experiencing problems with the older metal-on-metal hip implant, which has also been linked to a high number of failures.

Similar product liability lawsuits have also been filed over problems with Wright Conserve metal hips, BioMet M2A-Magnum metal hips and other metal-on-metal hip replacements manufactured by other companies.