Illinois Medical Malpractice Lawyers Blog

A recent, dramatic increase in the number of transvaginal mesh complications led the FDA to issue an updated public safety alert on July 13, 2011, warning users of the serious health risks associated with surgical mesh. Our vaginal mesh attorneys have firsthand experience with a growing number of vaginal mesh victims experiencing severe complications often requiring additional, painful surgeries. Some of the most common mesh-related problems we have witnessed include infections, urinary problems, and pain during sexual intercourse. These injuries continue to form the basis for a number of transvaginal mesh lawsuits against negligent device manufacturers.

Federal regulators first alerted the public to potential mesh complications back in 2008. After receiving more than 1,000 mesh injury reports, the FDA announced that transvaginal mesh used in pelvic organ prolapsed repair surgery may lead to "rare" problems such as serious urinary incontinence (SUI). The agency found that the surgical mesh can erode when implanted in the vagina, causing severe discomfort, bleeding, and pain. Mesh erosion can also require multiple corrective surgeries using additional mesh or stitches that are extremely expensive and may not resolve the problem.

Unfortunately, new data shows that mesh complications are not so "rare" after all. From 2008 to 2010, the FDA received nearly 4,000 reports of mesh-related injuries, including three mesh placement procedure deaths. Chronic pelvic pain, pelvic nerve damage, and painful sexual intercourse were also reported. The FDA's new, stronger warning is intended to spread public awareness about the frequency of mesh complications.

Recent studies show that approximately 10 percent of women who undergo transvaginal prolapse repairs experience mesh erosion within a year of surgery. In our opinion the risk clearly outweighs the benefits as the FDA further reported that the mesh failed to increase the effectiveness of surgery. In most cases, pelvic organ prolapse can be treated without using these dangerous surgical meshes.

Complications were reported against nine transvaginal mesh manufacturers, including Mentor ObTape, a subsidiary of Johnson & Johnson that agreed to a number of large settlements last year with women who experienced debilitating health problems. Mentor ObTape was removed from the market in 2006. A growing number of lawsuits have also been filed by victims of Bard's Avaulta Anterior and Posterior Biosynthetic Support System, alleging that the company failed to warn users of serious health complications resulting in pain and disfigurement.

Our vaginal mesh attorneys know that manufacturers of a defective device are liable for the serious injuries that users suffer. Legal claims such as strict liability, negligence, fraud, and breach of implied or expressed warranty can all be brought against vaginal mesh manufacturers that fail to warn consumers of the risk of serious vaginal mesh side effects.

The FDA found clear risks associated with transvaginal mesh placement procedures, and an advisory meeting is scheduled in September 2011 to discuss the possibility of an outright ban. Mesh-related infections, urinary problems, pelvic discomfort, and other chronic health problems that dramatically impact a women's quality of life are on the rise and negligent manufacturers need to be held responsible. These serious side effects have been known for years, and transvaginal mesh manufacturers should have warned consumers of the serious risks.

A new report from the Government Accountability Office reveals that the U.S. Food and Drug Administration is not doing enough to follow up on defective medical devices, such as the recently recalled DePuy hip replacement system, that cause deadly side effects. Our Illinois product liability attorneys know that recalls are an important tool to prevent safety problems associated with defective devices. But more needs to be done in order to mitigate patient harm. The latest government report shows that the FDA is missing an important opportunity to protect consumers from medical devices that cause serious personal injury or death.

According to the report, more than 700 defective medical devices are recalled every year, and many of these devices carry a serious health risk. Cardiac devices are most commonly recalled, along with radiology devices. In 2010, a hip replacement system manufactured by DePuy Orthopedics hip replacement system was recalled, and hundreds of lawsuits are pending against the medical device manufacturer. Studies show that 1 in 8 patients who received a recalled DePuy hip required a second, painful revision surgery. Zimmer's NexGen line of knee replacement systems was also recently recalled, after patients experienced loosening and severe pain.

Even after these dangerous medical device products are recalled, the danger remains. The FDA is not doing its part to ensure that the recalled devices are off pharmacy shelves or hospital inventories. Surprisingly, the agency has no way of assessing whether or not manufacturers actually pulled every recalled device off the market. The report found several cases in which dangerous medical devices could not be located, and manufacturers just assumed that consumers threw them away.

This report is troubling because a significant number of recalled devices cause serious adverse health problems, and the FDA's lack of oversight exposes patients to unnecessary risk. Defective device patients and medical providers need to be consistently informed about potential product hazards in order to prevent permanent harm.

Continue reading "FDA Needs More Oversight of Defective Medical Device Recalls to Prevent Adverse Events" »

Illinois medical device lawyers at Pintas & Mullins have long questioned the safety of metal- on- metal hip implants. Our clients have suffered debilitating consequences from defective hip replacement systems and continue to experience serious hip implant complications. We are cautious about the first ceramic metal-on-metal total hip replacement system approved by the FDA on June 13, 2011. This system is similar to DePuy's recalled ASR hip systems, which released toxic metal particles into patients' bodies. The FDA recently ordered DePuy and 20 other hip implant manufacturers to conduct more research on the side-effects patients are experiencing, further raising concerns about the dangers of these devices.

The newly approved hip implant system combines a ceramic ball with a metal socket. A two-year clinical trial found no difference between patients implanted with the ceramic-on-metal system and patients implanted with a metal-on-metal system. As the Wall Street Journal reports, DePuy Orthopedics must conduct post-market studies to monitor the side effects that patients experience. The FDA is primarily concerned with early failure rates and complications that lead to increased metal concentrations in the blood. These dangerous health effects led DePuy Orthopedics to recall more than 100,000 metal-on-metal hip implants in August of 2010. Independent studies show that as many as 49 percent of defective DePuy hips failed, causing patients severe pain and forcing many of them to undergo expensive corrective surgeries. As the metal-on-metal hip implants deteriorated, they shed metallic ions into the surrounding tissue and bloodstream, leading to problems ranging from deafness to heart failure.

Depuy hip manufacturer Johnson & Johnson faces more than 1,000 Depuy hip lawsuits, including a recently filed Illinois suit by a hip recall victim who suffered from dangerous levels of chromium in his bloodstream and was forced to undergo a second hip implant operation. Like thousands of DePuy hip victims around the country, he reasonably relied on the advice of his doctors and experienced life-changing complications. Our Chicago hip implant lawyers hope that the latest ceramic hip implant device can avoid causing patients similar health complications, but only time will tell whether problems will arise.

Continue reading "FDA Approves New Hip Replacement System, Demands More DePuy Defective Hip Research" »