Consumer Reports Investigation Warns Patients About Defective Medical Devices
A new Consumer Reports investigation reveals that although most consumers would expect their medical implants to be tested for safety, many medical devices such as ASR hips or vaginal mesh never underwent clinical testing before they went to market. In fact, patients might have a hard time learning that the implanted device has safety issues—or even know which device they received at all.
Consumer Reports pointed to the especially alarming case of the DePuy ASR hips, which were implanted in 93,000 people worldwide and recalled in August 2010 due to high early failure rates. Consumer Reports interviewed one recipient of the ASR hips, Suzy Mansfield, who didn’t hear anything about the hip recall until she read a news story in the Boston Globe over five months later. She only knew that she had a DePuy hip from a small card with the brand’s name, which was given to her to help her through airport security. “I would be happy to a sign a statement allowing my name and contact information to be given to the manufacturer so they could contact me in the event of a recall or product problem,” Mansfield said. Instead, she was left to uncover information about the recalled ASR hips on her own.
Consumer Reports is advocating for changes that would make the medical device industry safer for patients. One such recommendation is to attach a “unique identifier,” akin to a serial number to each device, so that patients can quickly learn about recalls and other safety issues. Another is to create a national registry so that patients can report and be informed of problems associated with these medical devices quickly.
ABC, CBS News Stories Follow Consumer Reports Investigation
Following the release of the Consumer Reports investigation, major news outlets such as ABC and CBS shared the information about untested medical device implants by posting stories of individuals who were affected by them. ABC News told the story of Dr. Stephen Tower, an orthopedic surgeon who received a DePuy ASR metal-on-metal hip implant. Like other recipients of the ASR hips, he began experiencing symptoms of metallosis, or metal poisoning, when the metal joints released toxic cobalt in to his body, causing serious pain and tissue, heart, brain and thyroid problems. Dr. Tower underwent a revision surgery to remove the defective hip and replaced it with a plastic and ceramic hip instead.
ASR Hips And Transvaginal Mesh Cause Problems For Patients, Require New Measures For Change
Consumer Reports’ Nancy Metcalf told ABC News that the ASR hips were never clinically tested before the FDA approved them for sale in the U.S. Consumer Reports also took on another untested and dangerous device–transvaginal mesh. Metcalf said that “hundreds of thousands of women have had mesh slings inserted to support internal organs as they age…again, these products were never clinically tested before being marketed for this use.” The FDA’s database shows thousands of complain about the mesh, “including debilitating infections.” But transvaginal mesh remains on the market, not even classified as high-risk. Metcalf suggests that the FDA should institute “rigorous testing” for medical implants in the same way that they do for prescription drugs.
CBS News interviewed Dr. Steven Nissen from the Cleveland Clinic, who co-authored an independent report which found that over 2,800 patients died in 2006 from defective medical devices. “There is a consistent pattern of failure in medical devices,” Nissen told CBS News. DePuy issued a statement in response to CBS’ inquiries: “Dozens of tests and studies relating to the design, materials, and performance of components” of their recalled hips “were conducted,” and made sure to point out that the ASR hips were “cleared for marketing by the FDA.”
Consumer Reports Investigation Follows ASR Hips Lawsuits
CBS News also spoke to 56 year old Terri Sagalow, who had both of her hips replaced with ASR hips within two years. Only after did she learn that both of her metal-on-metal ASR hips were recalled. “I’m finding out now that these things that they put into me weren’t even tested,” Sagalow said. “And they’re in my body. It’s really quite upsetting.” Sagalow is now one of thousands of patients filing an ASR hips lawsuit against DePuy.
Individuals who received ASR hips or transvaginal mesh and have been injured may want to consider pursuing legal action against the respective medical device manufacturer. You may be entitled to compensation for your medical expense, lost wages, and pain and suffering. Contact a Bernstein Liebhard LLP lawyer today for a free case review. The lawyers at Bernstein Liebhard LLP have recovered over $3 billion on behalf of their clients, and will guide you through the complex litigation process.