On August 4, 2011, the New York Times addressed the safety of the medical device process currently used by the U.S. Food and Drug Administration (“FDA”).  Under the current regime, medical device manufacturers can circumvent the FDA’s rigorous clinical testing by claiming that products such as transvaginal mesh and artificial hip implants are substantially similar to medical devices currently available on the market.  This loophole known as the FDA 510K process has been the subject of recent scrutiny, following a recent report issued by the Institute of Medicine (“IOM”), recommending that the FDA abandon the 510K process.  The IOM found that the current FDA 510K process fails to adequately examine medical devices, such as the DePuy ASR metal on metal hip implants and transvaginal mesh for their safety and effectiveness.  The IOM’s report on the safety of the medical device process specifically highlighted metal on metal hip implants, used in total hip replacement surgeries, and transvaginal mesh, used to treat pelvic prolapse, vaginal prolapse, cervix prolapse, and bladder prolapse as unsafe for consumers.   

New York Times Cites Transvaginal Mesh As Prime Example Of Defective Medical Device

Transvaginal mesh is a type of material that is surgically placed inside the body through an incision in the vaginal wall to treat certain medical conditions, such as vaginal prolapse, pelvic prolapse, cervix prolapse and bladder prolapse.  Recent reports have indicated that the medical device has led to erosion, pain, vaginal scarring, and urinary problems.  Moreover, the FDA recently issued an advisory to patients and doctors, recommending that they consider alternative treatments to repair conditions such as pelvic prolapse because of the dangers associated with transvaginal mesh implants.  In addition, the FDA announced that a panel will convene in September to determine whether transvaginal mesh should be recalled.  If the medical device had not been approved through the 510K process, it is possible that many women could have been spared the painful side effects associated with transvaginal mesh implants.

FDA 510K Medical Device Approval Process Responsible For Metal On Metal Hip Recall

In August 2010, DePuy recalled its ASR products, which were used in hip arthroplasty procedures.  Approximately 37,000 individuals in the United States received the defective ASR metal on metal hip implants. Certain individuals who underwent hip arthroplasty received a total hip replacement, whereas other individuals underwent a hip resurfacing. Many of the individuals who received the DePuy ASR hip implants have experienced hip replacement pain; some have had to have revision surgery in order to remove the defective metal on metal hip implants.  Similar to transvaginal mesh, the recalled hip arthroplasty devices manufactured by DePuy received market approval through the FDA 510K process.

Defective Medical Device Complications Result In Lawsuits

If you or a loved one has experienced complications as a result of being implanted a defective medical device such as transvaginal mesh to repair vaginal prolapse, pelvic prolapse, cervix prolapse, or bladder prolapse or hip replacement pain as a result of being implanted with a metal on metal hip, you may be able to file a lawsuit seeking compensation for your medical expenses, pain and suffering, lost wages and more.  Contact one of our lawyers today for a free and confidential lawsuit evaluation.  The lawyers at Bernstein Liebhard LLP have extensive litigation experience, and have recovered billions of dollars for their clients.  In addition to being staunch advocates for your claim, our lawyers also provide personal attention to guide you through the complex litigation process.

Published August 5, 2011 by