If we know a product is unsafe – whether that’s been decided by the manufacturer, the FDA or a court – it shouldn’t be out there. Period. If lawmakers are serious about protecting people, they’ll pass this bill.
Baltimore, MD (PRWEB) March 15, 2012
Maryland transvaginal mesh injury attorney Robert K. Jenner today voiced support for recently introduced federal legislation that could lead to fewer dangerous medical devices making it to the U.S. market.
Last month, four lawmakers introduced the Safety of Untested and New Devices Act (SOUND Devices Act), or H.R. 3847. The House Energy and Commerce committee is reviewing the bill.
Under current rules, the U.S. Food and Drug Administration (FDA) must approve medical devices that have designs based on products that have already been cleared for sale. The FDA can only reject devices if they are based on a product that was recalled by the FDA or a court.
As a recent Bloomberg News article points out, these rules leave a “loophole.” They allow devices to make it to the market that are based on products that were voluntarily recalled by manufacturers before the FDA or a court could act.
The SOUND Devices Act would change that. It would give the FDA the power to reject new devices that are based on products that have been recalled by manufacturers.
As the Bloomberg News article pointed out, the FDA had approved certain transvaginal mesh products for sale even though some had traced their designs to a product that had previously been the subject of a manufacturer recall.
“The reality is that the FDA’s current approval process is allowing too many medical products to be cleared that are based on flawed designs,” Jenner said. “It’s allowing a dangerous design to be multiplied, basically. Unfortunately, the number of injuries gets multiplied as well.
“If we know a product is unsafe – whether that’s been decided by the manufacturer, the FDA or a court – it shouldn’t be out there. Period. If lawmakers are serious about protecting people, they’ll pass this bill.”
Jenner leads the Mass Torts Division for the nationally recognized personal injury firm of Janet, Jenner & Suggs, LLC. He been listed in the top echelon of Maryland Super Lawyers for six consecutive years.
Currently, Jenner and his legal team are investigating reports of female patients who have suffered side effects and complications after receiving transvaginal mesh implants for the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
In a July 2011, the FDA said it had received thousands of reports of complications associated with these surgical mesh devices. The complications included mesh erosion, pain, infection, bleeding, vaginal scarring and shrinkage and related emotional problems.
“There is legal help available for these women and their families. They may be able to recover money that can help pay for the medical care they need and compensate them for their pain and suffering,” Jenner said.
“But we need to do more to make sure these injuries never happen in the first place. We need to keep unsafe products off the market.”
About Janet, Jenner & Suggs, LLC
The law firm of Janet, Jenner & Suggs, LLC, is a nationally recognized law firm dedicated to representing victims of defective products, medical devices, prescription drugs and medical malpractice. Each of the firm’s principals is named in The Best Lawyers in America® and Super Lawyers®. The firm has offices in Baltimore, Maryland; Columbia, South Carolina; and Asheville, North Carolina. The firm accepts clients and referrals from clients and attorneys throughout the country. For more information about claims related to transvaginal mesh products, contact the firm at (888) 463-3529 or through the firm's online contact form.