There are several different models of the Biomet artificial hip, including the Exceed ABT, the Stanmore, and the M2a Magnum. These are medical devices used by surgeons to repair damaged hips. The Biomet hips, made by the medical device manufacturer based in Indiana, are used to replace an older artificial hip, to repair damaged parts of the joint, or to completely replace the hip joint.
For some people, replacement of part or all of the hip joint with products like those from Biomet, is necessary to regain mobility and to eliminate pain. Unfortunately, there have been some serious problems with some of these artificial joint products, including metal poisoning, tissue damage, and pain that require revision surgery. Because of the illness and damage caused by the joints, many lawsuits have been filed against Biomet and settlements reached.
Who Gets Hip Replacement Surgery?
There are several possible situations in which a person may be a good candidate for hip replacement surgery. Typically it is damage to the hip joint that causes significant pain and reduction in mobility, enough to interfere with daily life that makes someone eligible for this type of surgery. Osteoarthritis is a common condition that causes enough damage to require hip surgery.
Other conditions that may eventually lead to hip replacement include rheumatoid arthritis, osteonecrosis, and cancer of the bones. A person may also need hip replacement after an accident that caused injury, fractures, and other damage to the hip bone. In previous decades hip replacement was mostly reserved for patients over the age of 60 because older patients were less likely to put a lot of strain on the artificial joint. Improved technologies in the artificial joints and in surgical techniques have made it possible to successfully provide younger, more active people with artificial hips.
Hip Replacement Surgery
Artificial hip systems are used in total hip replacement and hip resurfacing surgeries. A total hip replacement is done to remove entire damaged portions of the hip joint. The hip is a ball and socket joint, and during this type of surgery, both the ball and the socket are removed and replaced with artificial components. A stem is also used to connect the ball to the femur, the leg bone.
When the entire joint has not been compromised by damage, a surgeon may be able to save parts of it. In resurfacing surgery, the damaged parts of the ball in the joint are removed and a cap is placed on it. Damaged portions of the socket may also be removed and a lining placed within it. Hip revision surgery occurs when part of a hip replacement fails and needs to be recovered and replaced.
Risks and Complications of Hip Surgery
Regardless of the type of implant used or the type of hip surgery, this is a serious procedure that comes with risks. Patients and their doctors must weigh the possible risks against the benefits before proceeding with a surgery. As with any type of surgery, hip replacement may cause a heart attack, blood clotting, excessive bleeding, infections, and a bad reaction to general anesthesia.
Hip surgery in particular has the potential to lead to certain adverse reactions, which may occur even well after the surgery. These include bone fractures, the dislocation of the new joint, nerve damage that causes weakness and numbness, infections in the joint, loss of bone, a difference in the lengths of each leg, and loosening or breakage in the artificial joint. Any of these possible outcomes may require additional surgery.
Metal-on-Metal Hip Implants
Artificial hip implant systems that are approved by the U.S. Food and Drug Administration (FDA) may be made of one or more of three different materials: polyethylene, a type of plastic, ceramic, or metal. Many of Biomet’s artificial hips are made of metal, also known as metal-on-metal hips. These kinds of hips include a ball, a socket, and a stem that are all made of metal. They are most often used in younger patients who will be physically active for longer because metal components are more durable.
Biomet Artificial Hips
Biomet has designed and created a number of different hip replacement components in different materials, but it is the metal-on-metal hips that are cause for concern. Biomet manufactures complete hip systems for replacement surgery. They also make parts for revision surgeries and resurfacing surgeries. Some of the specific systems that have led to problems include the M2a Magnum, Exceed ABT, and Stanmore products.
The Problems with Metal-on-Metal Hips
Since they have been available on the market the FDA has issued several warnings about metal-on-metal hips. These warnings outline the safety concerns and include recommendations for surgeons and patients. The FDA has stopped short of banning metal-on-metal hips. The major concern is that when the hip joint moves, the metal of the ball rubs against the metal of the socket and small pieces of metal wear away and get into the joint and even into the bloodstream.
According to the FDA there is no reliable way to know who will have a bad reaction to these fragments of metal. There have been reports of some patients having higher than normal levels of metal ions in the bloodstream. This can lead to illness, sometimes called metal poisoning, with symptoms and complications that may include fatigue, gastrointestinal upset, dizziness, headaches, kidney damage, a weakened immune system, cancer, and damage to the nervous system.
Over time many patients experience what is called an adverse local tissue reaction, or ALTR. These reactions can cause pain and damage to the joint that leads to it loosening. Eventually the damage caused by the loose pieces of metal hip means that further surgery is needed to replace the joint or components of it.
The FDA recommends that patients with metal hips should have regular blood tests for metal ions as well as X-rays to monitor the state of implants. Both of these steps are important whether or not a patient has any symptoms of metal poisoning or a failing implant.
The damage, injury, and illness that can be caused by Biomet’s metal-on-metal hip systems have led to numerous lawsuits against the company. One of the particular issues with Biomet’s M2a Magnum system is that it was approved through the FDA’s 510(k) system, an expedited process that doesn’t require testing of the device. Biomet was able to use this process because similar devices had been tested and approved, but it does mean that the company is vulnerable now to claims that it did not adequately warn patients and doctors of risks.
Many of the multiple lawsuits filed against Biomet were consolidated in Indiana in 2012, where the company is based to more efficiently settle the complaints. By January 2014, Biomet was prepared to settle and release $56 million, enough for about $200,000 to be awarded to each plaintiff in the case. In spite of the settlement, Biomet claims that injuries and illnesses were not caused by its hip products. If you have been injured or made sick by a Biomet metal-on-metal hip, talk to a lawyer about your options. You may still be able to receive monetary compensation from the company.
- http://www.cbsnews.com/news/fda-to-scrutinize-safety-of-metal-on-metal-hip-implants/ http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM309404.pdf