FDA Seeking Stricter Regulations for Metal-on-Metal Hip Implants, Parker Waichman LLP Reports

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Parker Waichman LLP reports that the U.S. Food and Drug Administration (FDA) will tighten regulations for metal-on-metal hip implants. According to The New York Times, the agency intends to close a regulatory loophole that allows manufacturers to sell all-metal hip replacements without any clinical testing for safety or efficacy.

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Metal-on-metal hip implants, which the NYT article refers to as “one of the biggest device-related failures in decades,” have come under intense scrutiny due to reports showing that the devices shed metallic debris and fail at high rates.

Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, reports that that U.S. Food and Drug Administration (FDA) is seeking stricter regulations for the approval and sale of metal-on-metal hip implants. The New York Times (NYT) reports that the agency is seeking to close a regulatory loophole that came about as a result of a 1976 law. This loophole, known as the 510(k), allows manufacturers to sell metal-on-metal hip implants without any clinical testing for safety or efficacy. Metal-on-metal hip implants, which the NYT article refers to as “one of the biggest device-related failures in decades,” have come under intense scrutiny due to reports showing that the devices shed metallic debris and fail at high rates.

The new proposal would require manufacturers to show that metal-on-metal hip implants are safe and effective before continuing to sell the devices or acquire approval for new devices. Also, for the first time, the agency will advise metal hip patients to undergo routine testing to detect metal ions in their blood, particularly if they experience symptoms indicative of implant failure, such as pain or swelling.

According to The New York Times, the law in question is the Medical Device Amendments of 1976, which implemented different approval requirements for medical devices depending on their perceived risk and their role in sustaining a patient’s life and health. Low–risk devices were allowed to go through 510(k), a process that allowed devices to be sold so long as they were proven to be similar enough, or “substantially equivalent,” to a previously approved device. High-risk devices, such as heart defibrillators, were to undergo clinical testing before being introduced to the market. When the law came about, however, several medical devices, including all-metal hip replacements were already on the market at the time; lawmakers decided to allow these products to go through 510(k) temporarily until the FDA officially determined their risk status.

For metal-on-metal hip implants, however, the final classification never happened. As a result, NYT points out, the devices have been in “regulatory limbo” for decades as some 500,000 U.S. patients were implanted with a device that was never clinically tested. The FDA is now looking to change this; if accepted, the proposal will require device makers to submit clinical data showing that their products are safe and effective. Dr. William H. Maisel, deputy director for science at the FDA, told The New York Times that the new proposal was based on the “large number of patients who received these products and the numbers of adverse events associated with them.”

Metal-on-Metal Hip Implants Overview

Metal-on-metal hip implants have sparked a number of lawsuits following evidence showing that the devices fail more frequently than other types of implants (In Re: DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation, MDL No. 1:10 md 2197). While hip implants usually last approximately 15 years, metal-on-metal hip implants have been shown to fail at high rates shortly after implantation. The issue truly came to light in 2010, when Johnson & Johnson’s DePuy unit globally recalled their ASR hip implant. The recall was based on data from the National Bone and Joint Registry showing that the devices fail in some 13 percent of patients within five years.

In March 2012, a study published in the Lancet indicated that the high failure rate was a problem common to all metal-on-metal hip implants. The research showed that all-metal hip implants failed at a rate of 6 percent in five years while older devices, including metal-on-polyethylene and metal-on-ceramic implants, had a failure rate of about 2 percent in five years.

The FDA has asked a number of metal hip manufacturers to conduct post market studies evaluating whether or not the implants release toxic amounts of metal ions into the body when the surfaces of the implant rub or articulate together. Last summer, an FDA advisory panel met to discuss the pros and cons of metal-on-metal hip implants and make recommendations for their use. At the conclusion of a three-day meeting, the panelists advised that patients undergo yearly testing, imaging scans and, possibly, blood screening for metal ions. The NYT reports that for the first time, the FDA will officially recommend that metal-on-metal patients experiencing pain and other symptoms should undergo testing to detect levels of metal ions in the blood.

Parker Waichman LLP continues to offer free legal consultations to victims of metal-on-metal hip implant injuries. If you or a loved one experienced premature failure of your implant or other health problems associated with a metal-on-metal hip implant, please contact their office by visiting the firm's Defective Hip Implants page at yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).

Contact:
Parker Waichman LLP
Gary Falkowitz, Managing Attorney
(800) LAW-INFO
(800) 529-4636
http://www.yourlawyer.com

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Gary Falkowitz
Parker Waichman LLP
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