Biomet Hip side effects include hip pain, fractures, severe groin pain, loss of balance, instability, walking trouble, and metallosis, which can cause severe pain and inflammation and bone, tissue, and organ damage. We are working with some of the leading Biomet Hip attorneys in the country. A claim and/or Biomet Hip lawsuit can be filed on your behalf and there is no fee until you receive an award or a Biomet Hip settlement. Contact us for a free consultation online or toll free at 1-800-992-6878.
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As early as September 2001, the Food and Drug Administration (FDA) announced that Biomet would be implementing a recall for its hip implant devices. The device at issue was the zirconia ceramic femoral head, the ball part of the device that fits into the socket. This part was causing high fracture rates within 13 to 27 months after implementation, while most hip implants are supposed to last 15 years or more before requiring revision implants.
Later, the Biomet metal-on-metal hip implant devices were approved by the FDA in 2004. These were supposedly better than the earlier hip implant devices. However, over the past two years, the number of adverse reports to the FDA concerning the Biomet hip implants had increased from 11 in 2009 to 80 in 2011. These reports included problems like loosening, metal toxicity, chronic pain, bone loss, and popping or squeaking noises.
These all-metal implants carry the potential of depositing tiny shards of cobalt and chromium into the neighboring tissues. During normal wear and tear, as the components rub against each other, these shares can migrate into the tissues and bloodstream, causing a number of symptoms including:
- Difficulty walking
- Tissue death inside the hip
And in extreme cases, these hip implants can cause organ and bone damage.
Biomet Hip Side Effects
Those who have undergone a hip-replacement procedure have done so with a common goal in mind: to reduce hip pain and increase mobility. However, many of those how have undergone a hip replacement and used a metal-on-metal hip replacement system, such as the Biomet M2a-Magnum, have experienced side effects that only make their pain and mobility worse.
Common side effects of the Biomet M2a-Magnum Hip Replacement device include:
- Bone fracture
- Device loosening or dislocation
- Infection and scarring of the surrounding tissues and bone
Although the Biomet M2a-Magnum was introduced as a replacement for the company’s recalled Zirconia Ceramic Femoral Head, the device is having similar problems to that and many other companies’ metal-on-metal hip replacement devices. The common reported side effects are as a result of the device’s wear and tear through regular use, which causes metallic pieces to break off and get lodged in the surrounding tissue. The pieces of metal in the adjacent tissue cause infections and in some reported cases, tumors and pseudo-tumors. The breakdown of the metal-on-metal hip also results in the actual devices failure which can cause bone fracture.
Because the U.S. Food and Drug Administration has received approximately 17,000 adverse event reports regarding, the FDA recently created a panel of experts to determine whether or not metal-on-metal hip replacement systems, such as the Biomet M2a-Magnum, should even be allowed on the market. Additionally, 2012 article in the Lancet Medical Journal urged that, given the risks of device failure, metal-on-metal hip replacements should never be used. Because there are so many possible side effects that can results from a hip replacement failure, any person who has had one implanted should consult their doctor. An experienced hip replacement attorney or medical device attorney will also be helpful in explaining your rights and methods of recovery in the event you have been injured by these products.
Biomet Hip Medical Studies
The Biomet hip replacement system, the M2a-Magnum Hip System, was introduced and approved by the U.S. Food and Drug Administration in 2004. This system was intended to incorporate changes in the design of previous models and to be the replacement of the Biomet Zirconia Ceramic Femoral Head. That head, which was on the market between 1998 and 2001, was recalled after a significant amount of person experienced device failure within 13-27 months of the device’s implementation. Since that recall and the introduction of the Biomet M2a-Magnum Hip Replacement System, more than 110,000 persons were implanted with the new device. Despite the device’s popularity among physicians, the M2a-Magnum has run into the same problems of device failure and severe side effects as the system’s predecessors.
After reports of the device’s loosening and breaking, patients who have had the M2a-Magnum implanted have reported severe pain, bone loss and fracturing, and scar tissue and metal toxicity caused by pieces of the metal-on-metal hip device breaking off and entering the surrounding tissue and bloodstream. Because of the device’s failures, many patients have been forced to undergo corrective procedures, commonly known as “revision surgeries.” In 2011, the Australian National Joint Registry reported that 7.2% of the patients who had the M2a-Magnum hip replacement had undergone a revision surgery because of the device’s breaking. By 2013, the number of adverse events reports of the Biomet M2a-Magnum by The U.S. Food & Drug Administration was over 500.
The Biomet M2a-Magnum, which as intended to replace the company’s previously recalled device, joins a group of hip replacement systems that have been the subject of scrutiny from the courts, the FDA, and from the medical industry. Biomet joins Stryker, the DePuy ASR, the DePuy Pinnacle, and the Smith & Nephew hip replacement systems that have all been linked to the common, yet severe, side effects of metal toxicity of the surrounding tissues and bloodstream and hip fracture because the devices’ wear and tear causes metal pieces to break off. In 2012, the British Medical Journal published an article stating that approximately 14% of the total hip replacement users reported a failure in their “metal-on-metal” hip replacement systems. Alarmingly, the Journal of Bone and Joint Surgery published a medical study which found that 39% of the patients who had large diameter metal-on-metal hip replacement developed pseudo-tumors in the surrounding tissue because of the infections the broken pieces of metal caused.
Because of the dangers posed by metal-on-metal hip replacement systems, specifically the Biomet M2a-Magnum device, it is important to know the risks and your rights involved in the event an injury does occur. An experienced hip replacement attorney and medical device attorney can help you understand what options are available in the unfortunate case that you or someone you know has been a victim of severe hip replacement side effects.
Biomet Hip Lawsuits
Earlier this year, the US District Court consolidated the multidistrict lawsuits for the Biomet M2a Magnum Hip Implants in the US District Court for the Northern District of Indiana. (MDL 2931, In Re: Biomet M2a Magnum Hip Implant Products Liability Litigation). This lawsuit would qualify anyone that had received a Biomet M2a Magnum hip implant and had been at risk of serious and permanent injuries, particularly metallosis.
Metallosis is caused by the accumulation of metallic fragments, particularly cobalt and chromium, contained in the Biomet metal-on-metal hip implants. These fragments are released into the hip implant recipient’s body through normal wear and tear of the Biomet hip implants. These fragments could cause severe pain and inflammation and early revision surgery. Metallosis can lead to bone, tissue and organ damage, painful fluid build-ups, and loosening of the device, dislocation, or squeaking and popping noises.
The MDL recently added two new patients who have suffered metallosis due to the Biomet hip implants. One was a woman who recently filed a lawsuit in the US District Corut for the middle District of Florida. In addition to the defects mentioned above, the women also alleges that the Biomet hip implants were not properly tested for safety. Additionally, the M2a Magnum does not have the option of an acetabular cup liner, which would have prevented the running together of the metal components and the metal fragments from entering into the bloodstream.
Another lawsuit was filed by a man, as recently as December of 2012. The man claimed that he has suffered serious and permanent injuries as a result of the Biomet hip implant and is seeking damages for personal pain and suffering as well as the unexpected medical costs. He received his hip implant in March of 2009 and has already been forced to undergo revision surgery and is at risk of metallosis due to the rubbing of the metal components and the dispersing metallic particles throughout his body.
About Biomet Hip's Manufacturer
Four entrepreneurs, Dane Miller, Niles, Noblitt, Jerry Ferguson, and M. Ray Haroff founded Biomet, Inc. in 1977. The company had a rough start. At the time of incorporation, the company only had eight members, the founders and their wives. During the first year, they had sales of only $17,000 with a net loss of $63,000. But ever since the beginning, they had major technological advances such as direct compression molded polyethylene, titanium alloy constructive products and porous plasma spray coating.
In 1978, one of the founders, Miller’s grandmother received Biomet’s first hip implant. By 1980, Biomet reached its $1.1million mark in net sales. Biomet started its initial public offering (IPO) in 1982 and again in 1983 and 1986. In 1984, Biomet established international presence by acquiring Orthopedic Equipment Company and increase its manufacturing operations in Europe and bolstering its distribution network in the U.S.
In 1998, Biomet entered into a joint venture with Merck, further expanding the power of the company and its line of implantable devices. At the end of the 1990s, Biomet had net sales of $757.4 million and 2,750 team members in 26 facilities throughout the world. The company reached $1 billion in net sales in 2001.
Despite its early success in its products and expanding its facilities all over the world, Biomet’s defective hip implant products have led to multiple lawsuits beginning with its ceramic ball and socket hip implant, which was approved by the FDA in 2001. Then later, the metal-on-metal hip implants approved by the FDA in 2004, led to even more severe side effects and lawsuits. The patients complain about severe hip pain, trouble walking, and even metallosis, which lead to bone, tissue, and organ damage. These problems force potential plaintiffs to get premature revisions as soon as months after the initial surgery.
Biomet Hip Corruption Charges
At the same time that Biomet was facing lawsuits and claims that its metal-on-metal hip replacement systems were causing severe injury and side effects such as bone fractures, infections, and metallosis, the company was facing criminal charges brought by the U.S. Government. In March of 2012, the U.S. Securities and Exchanges Commission (SEC) and the Department of Justice (DOJ) charged the Indiana based medical device manufacturer with violating the Foreign Corrupt Practices Act (FCPA). Soon after the hip replacement device manufacturer was charged with the violations, it paid out $22 million in fines to both the SEC and the DOJ.
The charged violations of the FCPA centered on Biomet’s payment of bribes to doctors in China, Brazil, and Argentina for their use of Biomet products. It was alleged that for a period of 8 years, the company directly and through agents and international subsidiaries paid bribes ranging from 10% to 20% of the devices’ purchase price to doctors prescribing Biomet hips. Documents indicated that the company was using false invoices and was furnishing doctors with cash and gifts once they were done implanting a Biomet hip. The Indiana based company was quick to settle the case by paying the $22 million fine and by agreeing to comply with the FCPA for a period of at least 18 months.
Throughout the period that the company was extinguishing the criminal charges against its marketing and distribution of its devices, Biomet was facing multiple cases claiming its metal-on-metal M2a-Magnum hip replacement system was defectively designed because its failure to warn about the risks of injury and severe side effect, was resulting in patients suffering from toxic metal ingestions and broken bones. Although Biomet joined a long line of metal-on-metal hip replacement device manufacturers to face civil lawsuits that the devices are defective because they often break and cause metal debris to enter the surrounding tissue and bloodstream, the charges brought against the company by the SEC and the DOJ is a rare example of the imposition of criminal charges.
PLEASE SPEAK WITH YOUR DOCTOR BEFORE MAKING ANY MEDICAL DECISIONS REGARDING THE BIOMET HIP IMPLANT OR ANY OTHER MEDICAL DEVICE OR PRESCRIPTION MEDICATION.
Contact the Law Offices of d'Oliveira & Associates
If you believe that you or a love one had suffered severe pain, inflammation, or organ, bone, and tissue damage due to hip implants with Biomet Hip, you may want to speak with a defective medical devices attorney regarding a potential Biomet Hip lawsuit. An injury lawyer familiar with new developments in the investigation of Biomet Hip may be able to help you make important personal and legal decisions. d’Oliveira & Associates, P.C. is currently working with some of the leading lawyers in the country who are handling these cases.
Please contact the law offices of d'Oliveira & Associates at 1-800-992-6878 or fill out a contact form for a free legal consultation.