Medical devices are intended to correct a medical condition, but, in some cases, the medical device can do more harm than good. Like all manufacturers, medical device manufacturers have an obligation to provide consumers with safe and effective products. If a medical device is found to be dangerous or defective, the manufacturer may be liable for any resulting injuries.
In recent years some medical devices, including hip implants and transvaginal mesh, have been the subject of several lawsuits due to the medical complications that they have caused.
A number of hip replacement systems have been recalled recently, including Stryker’s recall of its Rejuvenate and ABG II Modular-Neck Hip Implant Systems in July 2012 and DePuy Orthopedics’ recall of the DePuy ASR XL Acetabular System and the ASR Hip Resurfacing System in August 2010.
Both hip implants are metal-on-metal hip implants, which have been known to result in corrosion and fretting which can damage or injure surrounding tissues. Metal-on-metal hip implants, like the Stryker Rejuvenate and ABG II hip implants, have been associated with significant risk of developing serious complications including tissue damage, device failure, need for revision surgery, and long-term disability due to corrosion and shedding of metal ions from the implants.
As this article states, the U.S. Food & Drug Administration (FDA) recently issued a report indicating that data indicates that metal-on-metal hip replacement systems are more likely to fail than other hip implant devices. According to Reuters, government data shows that a total of 500,000 patients in the United States have received metal-on-metal hip implants.
The DePuy ASR XL Acetabular System and the ASR Hip Resurfacing System were recalled due to a higher-than-normal failure rates associated with the devices and complaints that many patients were experiencing serious side effects from the hip replacement systems. Many doctors believe that the cup of the DePuy ASR him implant was too shallow, which led to improper implantation and other health complications, including the release of potentially dangerous levels of chromium and cobalt into the body.
The recalled DePuy ASR hip replacement systems have been used in more than 93,000 hip replacements since they were approved. In the past two years, the FDA has received more than 300 complaints regarding the devices, including loose hip cups, hip dislocations, bone fractures, pseudotumors from metal debris, allergic reactions and permanent muscle and tissue damage. Data has shown that in the five years following implantation of the ASR Hip System, 12% of patients who received the ASR resurfacing device, and 13% of patients who received the ASR total replacement system, have required a subsequent hip revision surgery to correct the medical problems caused by the ASR system.
Transvaginal mesh, which is used to treat incontinence caused by muscle weakening and pelvic organ prolapse, have come under fire in recent years for causing serious injuries, including infections, pain, and other complications, and hundreds of lawsuits have been filed in recent years. Lawsuits allege that the manufacturers of transvaginal mesh implants, including Johnson & Johnson (J&J), C.R. Bard, Ethicon, Boston Scientific, and American Medical Systems, failed to warn patients and doctors about the increased risk for medical complications.
As we reported, J&J announced in June 2012 that it would stop selling four types of mesh implants used to treat urinary incontinence. In 2008, the U.S. Food and Drug Administration (FDA) warned consumers that the implants were associated with complications, but that such complications were rare. Between 2008 and 2010, however, the FDA reported a substantial increase – a fivefold increase – in the number of injuries reported. Earlier this year, the FDA ordered manufacturers of the urinary implants to conduct further studies regarding the safety and risks associated with the medical implants.
The Chicago defective medical device law firm of Ankin Law Offices, LLC is committed to protecting the victims of substandard medical care and unsafe medical devices. If you have suffered injuries as a result of a hip implant or transvaginal mesh implant, do not hesitate to contact the skilled Chicago product liability attorneys at Ankin Law Offices at (312) 600-0000 to schedule a free consultation to discuss a possible medical malpractice or product liability claim.