Boston Scientific Corp. is adding new safety warnings to the labels for its medical devices that are among the most heavily litigated: surgical mesh devices that are used to repair pelvic disorders in women.
The medical device manufacturer has faced thousands of personal injury lawsuits from women who claim they were injured when their devices and dangerous pelvic slings became infected, or eroded surrounding tissue. This week, Boston Scientific stated that it was adding ‘erosion’ and ‘ongoing pain’ to the list of warnings on the medical devices.
The new label will state that meshes and slings are considered to be permanent implants, and that removal can be complicated or impossible.
Transvaginal slings are commonly inserted to treat stress urinary incontinence. Surgical meshes are implanted to strengthen tissue in patients who suffer form pelvic organ prolapse.
The label changes affect five Boston Scientific brands of slings – Advantage, Lynx, Obtryx, Obtryx II and Solyx – and three types of mesh – Uphold LITE, Pinnacle LITE, and Upsylon Y.
As of May 2, 2016, the company was facing more than 35,000 product liability lawsuits related to the devices. Boston Scientific has been sued for flaws in design and manufacturing; failure to warn of known dangers; breach of warranty; fraud; and loss of consortium.
Our Take
There are many medical devices and related products coming onto the market every year. One of the common questions our medical device product liability lawyers hear about defective or dangerous medical products are: ‘I don’t know the name of the manufacturer of my medical device. Can I still bring an injury claim?”
Yes. That is a major reason why you should possibly contact a medical device personal injury attorney. He or she can obtain the medical records pertaining to the device and those records usually show the manufacturer, model and even the UPC sticker.
Just as importantly, product liability attorneys constantly share information about lawsuits and medical devices nationwide. We let each other know if there are any class action lawsuits ongoing regarding a certain device, or any mass claims for similar consumer injuries from a device.
This type of information sharing among experienced product liability/medical malpractice attorneys is very important in securing large settlements for clients. Those funds are critically important in assisting their recovery and making up for losses in wages that their injuries may have caused.
Rick Shapiro has practiced personal injury law for over 30 years in Virginia, North Carolina, and throughout the Southeastern United States. He is a Board-Certified Civil Trial Advocate by the National Board of Trial Advocacy (ABA Accredited) and has litigated injury cases throughout the eastern United States, including wrongful death, trucking, faulty products, railroad, and medical negligence claims. During his three-decade career, Shapiro has won client appeals before the VA Supreme Court, VA Court of Appeals, NC Supreme Court, SC Supreme Court, WV Supreme Court, TN Supreme Court, and three times before the United States Court of Appeals for the Fourth Circuit, underscoring Shapiro’s trial achievements. In addition, he and his law firm have won settlements/verdicts in excess of $100 million. His success in and out of the courtroom is a big reason why he was named 2019 “Lawyer of the Year” in railroad law in U.S. News & World Report's Best Lawyers publication (Norfolk, VA area), and he has been named a “Best Lawyer” and “Super Lawyer” by those peer-reviewed organizations for multiple years. Rick was also named a “Leader in the Law, Class of 2022” by Virginia Lawyers Weekly (total of 33 statewide honorees consisting of lawyers and judges across Virginia). And in September 2023, Rick was selected as a recipient of the National Board of Trial Advocacy (NBTA) 2023 President’s Award. Although many nominations were submitted from across the country, Rick was just one of eight attorneys chosen by the prestigious National Board which certifies civil trial attorneys across the U.S. Rick was also recently named to Virginia Lawyers Weekly 2024 Virginia’s Go To Lawyers Medical Malpractice. The attorneys awarded this honor are nominated by their colleagues and chosen by a panel from the publication.
Comments for this article are closed.