There are many concerns for the hundreds of thousands of people who have had hip replacement surgeries using the metal-on-metal (MoM) replacement hips. With a recall announced by yet another company who makes these products, it seems to be just the tip of the iceberg. Biomet, DePuy and now Stryker have all had recalls issued for similar devices, but are these recalls too late for the patients who already have them in their bodies? With almost 17,000 complaints already logged to the FDA about adverse reactions to MoM devices, the problem seems to be getting worse.
FDA Studying Metal on Metal Hip Safety
The basics behind the medical problems associated with MoM’s are that metal particles that are released as the bearing surfaces wear over time. All hip replacements, regardless of material, wear and release particles into the body. However, the concern with MoM devices is that these particles, primarily chromium and cobalt, may cause immediate and possible long-term health problems. Some of the problems the FDA reported in a memorandum for the meeting scheduled in June 2012 for the Orthopaedic and Rehabilitation Devices Advisory Panel on MoM include:
- Bone Osteolysis. In hip replacement, this is the bodies attempt to eliminate particles from wear that causes an autoimmune reaction. This reaction can cause the body to absorb living bone tissue that can lead to bone weakening and cause the implant to loosen.
- Aseptic lymphocytic vasculitis-associated lesions (ALVAL). This is a fairly newly coined medical term and is also described as “pseudotumors”. These are soft tissue masses that form around the MoM implant site and may be caused by hypersensitivity to the metal particles.
Adverse Tissue Reactions from Metal Particles
The FDA termed these reactions “adverse local tissue reactions (ALTR)” or “adverse reaction to metal debris (ARMD)”. They are associated with joint pain, implant loosening, device failure, and the need for revision surgery with the MoM hip replacement.
The FDA panels finding at the June 2012 meeting point to ongoing research to standardize testing for metal in the patients as well as asking the manufactures of MoM implants to do more safety testing. However, the panel chair, Dr. William Rohr of Mendocino Coast District Hospital, was quoted “I do not use metal-on-metal hips, and I can see no reason to do so.” It was also speculated that the panel agreed that there were few, if any, cases that they would recommend implanting the MoM devices.
For the estimated 500,000 Americans that have already had MoM hip replacements, the panels, research, recalls and recommendations may be too late. These products are not tires or household appliances that can be easily recalled and returned to the manufacture. Removing the device requires a painful surgery and many patients still report pain even after the device is removed. The long-term effects these devices will have on the patients with adverse reactions are still unknown.
Attorneys for patients with a Stryker & other metal hip devices
Rosenfeld Injury Lawyers remains at the forefront of the metal-on-metal hip device litigation. Our team of hip defect attorneys is reviewing all metal hip cases and is willing to see that you receive the justice that you deserve for your injuries. We offer free consultations and never charge a fee without a recovery for our clients. All of our clients receive personalized legal service from attorneys and are never simply a number serviced by support staff.