Product recall lawyers at Pintas & Mullins report that the FDA recently issued new guidelines for those with metal on metal hip implants.
In August 2012, Johnson & Johnson agreed to pay an estimated $600,000 to resolve the first three cases in Nevada over the DePuy’s ASR hip implants. Over 37,000 ASR implants were recalled in the United States in 2010, after more than 12% of the devices failed within five years. More than 6,200 ASR cases were consolidated in a multidistrict court in Ohio. The first ASR trials in Ohio are expected to begin in May and July of 2013.
Although ASR implants were recalled, the Pinnacle system remains on the market despite allegations of implant failure, metallosis, and other complications. Last week, the FDA updated itswebpage on metal-on-metal hip implants to reflect data reviewed at the Orthopedic and Rehabilitation Devices Advisory Panel meeting. The issues highlighted by the FDA include: failure rates and modes, metal ion testing, local and systemic complications, patient risk factors, and considerations for follow-up after surgery. The FDA is now providing updated safety information and will provide additional updates as necessary.
Concerns about metal-on-metal implants include risk of metal ions releasing into the bloodstream. In these implants, the metal ball and cup slide against each other during activity, causing wear and corrosion at connection points. Orthopedic surgeons generally take precautions during surgeries to optimize the way in which the ball and socket wear against each other, however, there is no way to completely avoid the release of some metal ions. All patients react differently to metal release into the bloodstream, and the FDA is currently stating that there is no possible way to determine who will experience reactions, what type of reactions, when they will occur, or how severe the reactions will be.
Over time, the metal implant may cause damage to bones, muscle, or other tissue in the surrounding area, which is referred to as an adverse local tissue reaction. This damage leads to pain, implant loosening, and device failure, which requires revision surgery. There have been significant and extensive reports from experts that note complications and potential early failure of metal-on-metal hip systems.
To date, the following metal-on-metal hip implants have been recalled: Smith & Nephew R3 Metal Liners, DePuy ASR XL Acetabular System, and Zimmer Durom Acetabular Component.
Cobalt poisoning is a long term adverse effects of metal ion release, which can lead to cognitive and cardiac damage. Other complications include loosening and dislocation of the implant, and bone fracture near the implant, which usually require revision surgery.
To cover the hip implant litigation, Johnson & Johnson has reportedly set aside more than $2 billion. In addition to the consolidated cases in Texas and Ohio, Johnson & Johnson is currently facing more than 2,000 claims in California, Nevada, and Maryland, among other states.
DePuy Orthopedics maintains that the Pinnacle device is not defected, although one lawsuit claims that the company knowingly concealed defects and misrepresented its safety and efficacy. Indications that the device is not functioning properly include: pain in the groin, hip or leg, swelling at or near the hip, limping or change in walking ability, and popping, grinding, clicking, or squeaking from the hip joint.
Patients experiencing any adverse reactions from metal-on-metal hip implants should speak with an experienced defective hip implant attorney Depuy ASR and Pinnacle hip lawyers at Pintas & Mullins will continue to investigate this issue and help those suffering injuries from these devices.