FDA to Review Metal-On-Metal Hip Implants

by Personal Injury Claims Blawg on May 25, 2012

Below is a guest personal injury law blog regarding the FDA’s upcoming review of metal-on-metal hip implants.

The Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee, which is part of the Food and Drug Administration, will host a public meeting on June 27 and 28, 2012, to discuss the metal-on-metal hip implant system. This comes almost two years after Depuy Orthopedics, a subsidiary of Johnson & Johnson, recalled its metal-on-metal ASR XL Acetabular Hip Systems.

The National Joint Registry of England and Wales released data saying that the five-year failure rate of the hip implants was at around 13 percent, which is one for every eight patients. Symptoms of the failure are: loss of vision, severe pain, implants loosening, dislocation of the implant, and toxic metal poisoning.

The FDA formed this committee to seek expert scientific and clinical analysis on the risks and benefits of the metal-on-metal hip arthroplasty systems based on the available scientific data. The decision comes almost a year after the FDA gave 145 orders for post market surveillance studies to the 21 manufactures of the metal-on-metal hip implant systems.

The Hip orthroplasty is used to increase the patient’s mobility and at the same time, reduce the pain by replacing the damaged hip joint where evidence of sufficient sound bone to seat and support the components.

The two categories of the metal-on-metal hip arthroplasty systems are:

1.    Metal-on-Metal total hip replacement (THR) systems consist of a metal ball (femoral head), a metal femoral stem in the thighbone, and a metal cup in the hip bone (acetabular component).  MoM THR systems are typically indicated for use in total hip arthroplasty in skeletally mature patients with the following conditions:
a.    Non-inflammatory degenerative joint disease (NIDJD) such as osteoarthritis, avascular necrosis, post-traumatic arthritis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
b.    Inflammatory degenerative joint disease such as rheumatoid arthritis;
c.    Correction of functional deformity; and,
d.    Revision procedures where other treatments or devices have failed.

2.    Metal-on-Metal hip resurfacing systems consist of a trimmed femoral head capped with a metal covering and a metal cup in the hip bone (acetabular component).  Hip resurfacing arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients having the following conditions:
a.    Non-inflammatory degenerative arthritis such as osteoarthritis, traumatic arthritis,  avascular necrosis, or dysplasia/developmental dislocation of the hip (DDH); or
b.    Inflammatory arthritis such as rheumatoid arthritis.

The meeting will revolve around mechanisims of failure, metal ion testing, imaging methods, complications, pre and postoperative risks, and clinical follow up considerations for patients with the metal-on-metal hips, according to the FDA website.

This story is brought to you by We help people who have fallen victim to defective metal-on-metal implants. To find out more information about defective hip implants, please visit our blog.

Personal Injury Claims Blawg

Personal Injury Claims Blawg

PI claims blogger at PIClaimsBlawg
Personal Injury Claims Blawg is a personal injury law blog, inviting contributions from practitioners, PI law firms and legal academics across the UK, US and beyond. The post above has been published because of the high value associated with the author's work. Contact us if you'd like to get published today.

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