FDA proposes metal-on-metal hip implant regulation

Under a proposed FDA rule published Jan. 18 in the Federal Register, manufacturers of each new metal-on-metal hip implant would be required to show scientific evidence that the device is safe before it would be “placed in commercial distribution.”

Currently, and up to 90 days after the regulation’s effective date, the device merely must be “found to be substantially equivalent to any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that [already is] in commercial distribution.”

Robert J. Binstock, whose law firm, Reich & Binstock, represents plaintiffs in metal-on-metal hip implant lawsuits, issued the following statement:

“The U.S. Food and Drug Administration’s quest to bring safe, effective and cost-saving medical devices to market for the benefit of patients is a laudable pursuit which reflects the agency’s abiding regulatory purpose. The FDA’s proposal to require manufacturers to perform clinical trials on all new metal-on-metal hip implant designs is a key component.

“The FDA’s move hopefully would help to ensure that a sector of the medical device industry no longer serves as its own regulator and that product safety does not acquiesce to market influences alone.

“In the meantime, the judicial process is thankfully there to deal with the entitlement to just compensation for victims of failed metal-on-metal hip implants who suffered metallosis and other sources of agony.”

The FDA would require either “the filing of a premarket approval application or a notice of completion of a product development protocol.”

A PDP, according to the proposed rule, “must provide, among other things: (1) A description of the device, (2) preclinical trial information (if any), (3) clinical trial information (if any), (4) a description of the manufacturing and processing of the device, (5) the labeling of the device, and (6) all other relevant information about the device. In addition, the PDP must include progress reports and records of the trials conducted under the protocol on the safety and effectiveness of the device for which the completed PDP is sought.”

A PMA “must include all data and information on: (1) Any risks known, or that should be reasonably known, to the applicant that have not been identified in this document; (2) the effectiveness of the device that is the subject of the application; and (3) full reports of all preclinical and clinical information from investigations on the safety and effectiveness of the device for which premarket approval is sought. A PMA must include valid scientific evidence to demonstrate reasonable assurance of the safety and effectiveness of the device for its intended use.”

The metal-on-metal hip implant lawyers at Reich & Binstock have represented clients who have suffered adverse reactions, some of which have required revision surgery, which stemmed from device failure. The FDA summarized those excruciating consequences in its proposed rule, including the following:

• “Loss or reduction of joint function. Improper design or inadequate mechanical properties of the device, such as its lack of strength and resistance to wear, may result in the loss or reduction of joint function due to excessive wear, fracture, deformation of the device components, or loosening of the device in the surgical cavity.”

• “Adverse tissue reaction. Inadequate biological or mechanical properties of the device or its breakdown products, such as its lack of biocompatibility, may result in an adverse tissue reaction due to dissolution or wearing away of the articulating surfaces of the device and the release of materials from the device to the surrounding tissues and the systemic circulation.”

• “Increased risk of premature device failure. Elevated adverse event rates for these devices may lead to an increased risk of premature revision.”

• “Infection. The presence of the prosthesis within the body may lead to an increased risk of infection. The distinctive risks associated with metal/metal total hip replacements in comparison to other types of bearing surfaces are the wear particles generated and release of metal ions. These wear particles and metal ions may cause adverse tissue reactions in addition to the standard osteolysis seen with different bearings for total hip replacements and may lead to an increased risk of premature device revision. These adverse tissue reactions include metallosis, hypersensitivity/allergy, tumor (pseudo) or aseptic lymphocyte dominated vasculitis associated lesion (ALVAL).”

Anyone who has suffered complications related to the failure of any of the following metal-on-metal hip implants may want to contact the experienced medical device attorneys at Reich & Binstock for a free consultation. They can examine a patient’s circumstances and determine whether there is an entitlement to compensation that would justify the filing of a metal-on-metal hip implant lawsuit:

• Biomet M2a Hip Implants
• Biomet M2a-Magnum
• Biomet Regenerex
• Birmingham Hip Replacement
• Birmingham Hip Resurfacing (BHR) system
• DePuy ASR XL Acetabular System
• DePuy ASR Hip Resurfacing System
• DePuy Pinnacle Acetabular Cup System
• DePuy PINNACLE ULTAMET Metal Liner
• Portland Orthopaedics Ltd. M-COR Modular Hip System
• RingLoc + Modular Acetabular System
• Stryker Hip Implants
• Wright CONSERVE Total Resurfacing Hip System
• Wright PROFEMUR Hip Implant
• Zimmer Durom Cup
• Zimmer Continuum Acetabular System

Reich & Binstock may be reached either through the electronic form on the national law firm’s Web site, www.reichandbinstock.com, or toll-free at 1-866-LAW-2400.