Consumer News Weekly (CNW) is joining with the U.S. Food and Drug Administration, medical researchers and other consumer groups in warning consumers about the dangers of metal-on-metal hip implant systems.
Hip implant victims have suffered serious infections, blood poisoning, organ damage and other serious health problems, according to hip implant lawsuits, company recall notices and consumer complaints.
CNW echoes the concerns about the safety of these medical devices which are now the subject of thousands of hip implant lawsuits. So many of these cases have been filed that the federal court system has been forced to consolidate many of them in several multi-district litigations.
Some of the products have been recalled by their manufacturers and one national non-profit consumer organization submitted testimony to Congress questioning whether the approval process for metal-on-metal hip implants provided adequate testing to ensure consumer safety.
Major news agencies such as The New York Times and Reuters have recently run stories about studies that show the metal-on-metal systems fail more frequently than metal-on-polyethylene or metal-on-ceramic models.
The central problem, as claimed in these hip implant lawsuits and confirmed in recall notices from the companies, is that the metal in the systems is susceptible to corrosion and metal flakes can be carried through the blood system, causing infections, organ damage and other serious physical problems.
CNW urges anyone who might be considering a hip implant to review these highlights of the controversy over the metal-on-metal systems, produced by such major manufacturers as Johnson & Johnson (through their DePuy subsidiary), Stryker, Wright Medical Group and others. All have been named as defendants in metal-on-metal hip implant lawsuits, according to court records cited below.
CNW also recommends that anyone who has had such a hip implant operation and suffered metal-on-metal failures protect their legal rights in such cases by contacting a hip implant lawyer.
There are multiple multi-district metal hip implant litigations underway. Among them are MDL2244 in the Northern District of Texas, MDL No. 2391 in the Northern District of Indiana and MDL 2197 in the Northern District of Ohio.
The issue of consumer safety with metal-on-metal system first drew public attention with the recall of the DePuy Orthopaedics ASR XL Acetabular and ASR Hip Resurfacing systems. These systems were implanted in 40,000 patients in the United States from August 2005 through August 2010. On August 26, 2010, DePuy, a unit of Johnson & Johnson, recalled its ASR hip implants.
That was followed by a massive recall by Stryker Orthopaedics of its Rejuvenate Modular and ABG II modular-neck hip stems. This voluntary recall was initiated due to the potential risks associated with modular-neck stems, including the potential for fretting and/or corrosion at or about the modular-neck junction, which may result in adverse local tissue reactions manifesting with pain and/or swelling.
Reuters waded into the controversy with a Nov. 30, 2011 report saying that “Modern, all-metal hip implants appear no more effective than traditional implants and may be less safe, according to a new report, a finding that could hurt the device makers and accelerate lawsuits. The report, published on Tuesday in the British Medical Journal, found that patients who received so-called metal-on-metal implants were more likely to require repeat surgery than those who received traditional implants.”
The report noted that are about 270,000 hip replacements in the country each year and that “over the past few years, reports have emerged that the metal implants fail at a greater rate than traditional implants.”
The New York Times, on Oct. 1, 2012, reported on a study in the British medical journal The Lancet that “urged women to avoid an alternative hip replacement procedure known as ‘resurfacing’ and also recommended against its use in smaller men. Resurfacing, the Times said, uses metal-on-metal systems:
“Resurfacing devices belong to a class of products know as metal-on-metal implants in which both the cup and ball of an implant are made of metal. Over the last two years, the use of all-metal implants has largely ceased because of evidence that they generate metallic debris as they wear, damaging tissue and muscle.”
CNW also notes that the national, non-profit consumer group Public Citizen not only questioned the safety of metal-on-metal devices, it also questioned the FDA’s “fast-track” approval process for such devices.
Here is part of the statement of concern submitted by Public Citizen’s Health Research Group to a Feb. 15 hearing by the House Subcommittee on Health of the House Energy and Commerce Committee’s Statement for Subcommittee on Health of the House Energy and Commerce Committee’s health subcommittee:
“Recent experience with metal-on-metal hip implants, such as the DePuy (Johnson & Johnson) ASR XL Acetabular System (ASR), shows the threat to patients when devices are approved without appropriate premarket clinical testing.
Metal-on-metal hip implants are devices whose ball-and-socket joints are made solely from metals like cobalt and chromium, in contrast to older hip implants made of other materials, such as metal and plastic.
While the FDA could potentially require PMA applications for these high-risk, permanently implanted devices, a current regulatory loophole allows them to be approved through the 510(k) premarket clearance process, which, as discussed below, does not require well-designed, randomized, controlled clinical trials in human subjects.
Although these devices appeared to be safe in bench tests, when placed in the human body, the devices can quickly begin to wear, depositing metallic debris in the surrounding tissues that causes severe soft tissue and bone damage.
For example, the DePuy ASR hip implant was cleared for marketing in 2005 under the 510(k) process without undergoing any clinical testing. After being permanently implanted in nearly 100,000 patients, the device was recalled in 2010 because of serious problems related to premature failure of the device due to erosion of the metal joint surface and migration of metallic particles into the surrounding tissues and blood-stream.
The end result has been characterized by some leading academic physicians as a ‘public health nightmare.’ To prevent such public health disasters, all implanted hip devices should undergo testing in well-designed, randomized, controlled clinical trials to assess their safety, effectiveness, and long-term durability.”
While Public Citizen was critical of the FDA’s approval process for systems, the agency has devoted a full web page to metal-on-metal hip implant systems in which it outlines some of the health concerns associated with these devices:
Concerns about Metal-on-Metal Hip Implant Systems
"All artificial hip replacement systems have risks related to implant or material wear. Metal-on-metal hip (MoM) replacement systems have unique risks in addition to the general risks of all hip implant systems.
Because the metal ball and the metal cup slide against each other during walking or running, some tiny metal particles may wear off of the device and enter into the space around the implant. Some of the metal ions from the metal implant or from the metal particles may even get into the bloodstream.
Orthopaedic surgeons take several precautions before and during the implantation surgery to try to optimize the way in which the ball and socket rub against each other so that fewer wear particles are produced. However, there is no way to fully avoid the production of metal particles.
Different people will react to these metal particles in different ways. At this time, it is not possible to know who will experience a reaction, what type of reaction they might have, when the reaction will occur, or how severe the reaction will be.
However, it is known that over time, the metal particles around some implants can cause damage to bone and/or tissue surrounding the implant and joint. This is sometimes referred to as an 'adverse local tissue reaction (ALTR)”'or an 'adverse reaction to metal debris (ARMD).'
Such a reaction may cause the implant to become loose or cause pain. Ultimately this can require a revision surgery where the old device is removed and replaced with another one.
In addition to these reactions to metal near the joint and implant, there are some case reports in the literature of a small number of patients in which high levels of metal ions in the bloodstream may have caused other types of symptoms or illnesses elsewhere in the body, including effects on the heart, nervous system, and thyroid gland."
What are the most common symptoms reported in connection with metal-on-metal hip implants? Here are the symptoms that the FDA, on the same web page, says that patients should be concerned about:
Patients who have metal-on-metal hip implants should be aware of potential symptoms which may occur after surgery and indicate that their device is not functioning properly. Common symptoms may include:
- Pain in the groin, hip or leg
- Swelling at or near the hip joint
- A limp or change in walking ability
Patients who receive a metal-on-metal hip implant should also pay close attention to changes in their general health or new symptoms outside their hip including symptoms related to their:
- Heart (chest pain, shortness of breath)
- Nerves (numbness, weakness, change in vision or hearing)
- Thyroid (fatigue, feeling cold, weight gain)
- Kidney (change in urination habits)"
CNW urges consumers to consider all of the warning signs about the dangers of metal-on-metal hip implants before undergoing such an operation. Your physician, of course, should be a main source of information and advice in such cases.