Jacksonville Faulty Medical Device Attorneys
Medical Devices That Are Not Reviewed By The FDA
Surgical Ablation Devices
They are widely used to perform atrial fibrillation but have not been cleared by the Food and Drug Administration. The U.S. Justice Department is looking into the marketing of surgical-ablation devices. They are made by Boston Scientific Corp., Medtronic Inc. and St. Jude Medical Inc. It took a whistleblower from within the industry to bring the issue of illegal marketing to light. Elaine George has filed whistleblower lawsuits against all three firms accusing them of marketing the devices to doctors and hospitals for unapproved use of steadying a faulty heartbeat. Because of her litigation, the Justice Department joined into the investigation. The federal government did join in a lawsuit against a different medical device maker, AtriCure. That firm has agreed to pay $3.8 million to resolve the accusations that it too marketed the surgical-ablation devices for unapproved uses. Because it is federal action, George receives $688,000 of the settlement, sharing in the fine because she is a whistleblower. Surgical ablation devices have sales of about $100 million a year. They are used almost exclusively to treat atrial fibrillation or an irregular heartbeat. The ablation part means that some tissue is destroyed which can stop bleeding. The FDA has never required the extensive clinical testing required before a medical device of this nature is approved. Doctors can opt to use devices off-label, but the companies may not promote that use directly to hospitals and doctors. Yet the investigation found documentation that leading device makers may have been doing just that. Aside from a medical device, it's estimated the majority of atrial fibrillation patients can be effectively treated with drugs. In the last two years there have been at least five patients who have died from procedures involving surgical ablation, including the Medtronic and AtriCure devices.
Mentor OB Tape
Lawsuits on behalf of women injured by the Mentor ObTape Vaginal Sling are proceeding. Four cases are scheduled for trial in California with the court denying Mentor's motions to dismiss. Johnson and Johnson owns Mentor. The ObTape is a vaginal sling that is approved by the FDA under a 510(k) process, meaning it must be substantially similar to something already on the market. There is no pre-market approval (PMA) for safety required. The tape was used by thousands of women between 2003 and 2006 to stress urinary incontinence, but complications resulted from the fact that the ObTape was nonwoven with a small pore which caused infections, severe pain, vaginal extrusions and urinary tract erosions. A study released last year found that one in five women might experience the complication of the sling eroding through the vagina. The complication rate may be as high as 17 percent, but patients or their doctors were not warned of the dangers. The product was taken off the market in 2006. Many women must have multiple surgeries to try and remove the synthetic tape remnants. When that is not accomplished, a woman can be left with permanent pain and debilitating injuries. This is not the only vaginal sling approved for women to treat urinary incontinence that do not have premarket approval. Other approved under 510(k) include the Gynecare TVT (tension-free vaginal tape) and American Medical Systems' Sparc Sling system. They received approval after claiming they were substantially equivalent to J & J's Protegen sling which was taken off the market in 1999 and call "adulterated and misbranded" by the FDA.
ReGen Biologics Menaflex Collagen Scaffold
When the product used for replacing the meniscus in the knee, was up for FDA approval under the 510 (l) process, scientists at the FDA's Center for Devices and Radiological Health (CDRH) concluded it needed to undergo premarket approval, or the submission of clinical trials to assure safety. Instead the congressional delegation of the company's home state of New Jersey contacted the FDA and the Menaflex was cleared under 510(k) in December 2008. The FDA's Deputy Commissioner Joshua Sharfstein wants to know how the Menaflex was approved and is conducting an internal review.
Intralase Device for LASIK Surgery
The Intralase device was cleared for approval under the 510(k) process in 1999. The device is a femtosecond laser that bladelessly creates corneal flaps for LASIK reshaping but patients complain of an array of problems from corrugated corneal strombal bed, extreme light sensitivity, partial flaps, flap necrosis, rainbow glare, among other problems. Injured patients are speaking out online and have formed networks to discuss LASIK-related problems which can include permanent vision loss and a variety of defects or inadequate vision. A study is underway into the array of side effects.
If you or a loved one has been the victim of medical malpractice or negligence in Florida, please contact our skilled Jacksonville medical malpractice lawyers immediately to discuss your Florida faulty medical device case.