Biomet Hip Lawsuit Settlement Funding
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Biomet Hip Lawsuit Funding
Many patients of the metal-on-metal (MoM) hip implants manufactured by Biomet have filed lawsuits against the company for complications like pain in the hips, dislocation, and soft tissue damage, all of which needed revision surgery.
The FDA approved the M2a Magnum line under the 510(k) approval system for circulation in the United States. This system does not test products prior to release, as long as they are similar with other products in the market. Biomet received lawsuits from patients who suffered pain and disability from products under the M2a Magnum line, with claims over faulty design.
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Biomet Hip Replacement Surgery; A Royal Pain in the … Hip
The M2a Magnum cases were consolidated in a multidistrict litigation and transferred to the Northern District of Indiana, as ordered by the judicial panel in October 2012. The multidistrict litigation was presided by Judge Robert L. Miller, Jr. The panel took note of the increasing number of complaints with allegations that the metal-on-metal design of the M2a Magnum produces dangerous levels of metal particles in the blood and surrounding tissues. Biomet agreed to settle all of the consolidated cases in early 2014, with an overall amount of $56 million. Each plaintiff received about $200,000 as a base award.
Plaintiff lawsuits mostly claim that Biomet is liable for the injuries of patients because of flawed design and failure to warn about health risks.
Numerous cases against Biomet were also filed in New Jersey state court. In past years, the New Jersey Supreme Court centralized cases associated with other hip implants, also through litigation.
Biomet Metal-on-Metal Hip Systems
Regardless of all the success the company has garnered over the years, it has also had its share of problematic medical devices; particularly, the metal-on-metal designs of hip implant products of M2a Magnum, Stanmore and Exceed ABT with optional metal liners. These three products have increased risks of severe complications like metal poisoning when the metal particles of the device breaks down and is released into the bloodstream. Biomet claims that the company produces the most extensive range of metal-on-metal hip devices in the industry.
What sets Biomet’s metal-on-metal hip systems apart from its competition is its improved monoblock component design. Modular hip systems have several interchangeable parts, as opposed to monoblock implants, which are constructed to be a single piece. The company specializes in acetabular monoblock components. They come with the liner, cup and ball as one entity.
Monoblock acetabular components have no need for screws, as they are nudged into the socket. These implants have a penetrable coating on the outside; therefore encouraging bone growth without the use of screws to hold the implants in place. These kinds of implants are not dependent on locking mechanisms to hold the liners in place, since these very liners are machined into the inside of the cup. Studies have shown that one-piece components such as Biomet metal-on-metal products have less debris buildup due to minor moving parts.
M2a Magnum Hip Implants
Biomet had released its M2a line of metal-on-metal implants in 1996; first introducing the M2a RingLoc. More than 110,000 M2a devices were implanted between the years of 1999 and 2009. Biomet claims that the M2a design boosts long-term performance while allowing larger ranges of motion and decreases dislocation risks.
The Biomet M2a metal-on-metal hip implant line has six different models, including the following: 28mm M2a-Taper, 32mm M2a-Taper, M2a-Magnum Tri-Spike, M2a Magnum, M2a-38 and M2a-RingLoc.
One of the company’s best selling devices, the M2a Magnum Large Metal Articulation was released in 2004 in the United States. After this launch, all M2a implant models have been complied under the M2a Magnum brand. All implants under this brand are monoblock implants, including several acetabular products, which also carry metal parts. The M2a Magnum products do not need cemented surgical techniques, which can be used either for primary or revision surgery. In addition, each M2a type has varying designs for the various needs of patients. The same implant line uses cobalt chromium, another metal, in the inside of the shell and for the ball.
M2a Magnum implants are designed for more active people, hence its larger head diameter for motion of up to more than 160 degrees. Because surgeons have options between larger head sizes, they have more room to find the closest fit possible for each patient. However, larger heads have been deemed more dangerous for patients. This is because of the larger head, which increases surface wear. Thus, more metal particles have the possibility of being released into the bloodstream as well as surrounding tissues.
Any metal-on-metal implant can have the side effect of metallosis, and the products in the M2a Magnum line are no exception to these adverse occurrences. Several problems associated with metallosis involve tissue discoloration, tissue necrosis, pseudotumors, groin pain, swelling and loosening of the said medical device, which can lead to dislocation or fracture. Patients with M2a Magnum implants have also suffered other conditions like soft tissue damage, among the aforementioned problems associated with metal-on-metal hip devices, less than a year after initial implantation. These problems are not easy to correct, often necessitating revision surgery.
FDA Warnings, Recalls and Reports
In spite of the FDA’s received reports of complications both from doctors and patients regarding the M2a Hip Implant line, the agency has still not recalled the company’s product. The FDA reported that in 2011, metal-on-metal devices were associated with over 12,000 adverse occurrences, in contrast with 6,332 for other types of implants.
Out of the many concerns and problems that were reported, it was found that the most common among metal implants was the need for revision surgeries. This issue was the driving factor in the FDA’s action to issue safety alerts about potential risks, as well as the requirement for more thorough monitoring of the devices. Regulation boards in the United Kingdom, Canada and Australia also issued safety alerts.
After the FDA had required manufacturers to adhere to the 522 postmarket surveillance studies in May 2011, Biomet was the first company to receive approval from the FDA after submitting its postmarket surveillance protocol in December 2010. Biomet still continues to study risks and benefits regarding the company’s wide variety of metal-on-metal hip replacement implants.
It was on July 2014 when the MAUDE Adverse Event Report on Biomet surfaced on the FDA website regarding the M2a Magnum Prosthesis. It showed that these adverse events range from subtle posterior dislocations, and pain in people who were found to have a mass on MRI and a metal-on-metal hip replacement implant.
As of November 2014, there have been over 450 reports to the FDA from patients and doctors regarding the M2a Magnum products, with numbers expected to grow. The reported side effects include pain, swelling, premature device failure and fractures.
Research published in the British Medical Journal stated that metal-on-metal implants that were created and improved in recent years do not live up to the promises of manufacturers regarding more effective and durable implants. Instead, there are even more threats to patients’ health as compared with older implants.
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