Johnson & Johnson (J&J) and its subsidiary, Ethicon have been ordered to pay $57.1 million in a case involving their TVT Secur pelvic mesh. According to court documents, the award to the plaintiff breaks down as $50 million in punitive damages and $7.1 million in compensatory damages, and may be the largest award to date against Ethicon in a vaginal mesh personal injury complaint. There are more than 100 additional transvaginal mesh cases pending in Philadelphia’s pelvic mesh mass tort program.
The Pennsylvania woman alleged she was diagnosed with urinary incontinence in 2005 and had TVT-Secur mesh implanted in 2007. However, the mesh did not provide any relief, so she had a second device implanted approximately two months later. That device eroded through her urethra on three occasions, and she had to undergo three revision surgeries between 2011 and 2016.
The plaintiff alleged that Ethicon and J&J neglected to inform patients and physicians and intentionally manipulated literature about the risks associated with the TVT products. In addition, she claimed that the companies failed to disclose information about complications to the medical community.
Hope was expressed that Johnson & Johnson and Ethicon would take notice of this latest verdict along with the other verdicts in Philadelphia and amend their practices accordingly, so that other women would not be hurt.
An Ethicon spokeswoman said the company plans to appeal the recent verdict, according to The Inquirer.
The national personal injury law firm Parker Waichman LLP has extensive experience and success in defective medical device litigation. Attorneys at the firm are available to answer any questions about filing a transvaginal mesh lawsuit.
Transvaginal Mesh Background
Transvaginal mesh is also known as pelvic mesh or TVM bladder sling. The device has been implanted in tens of thousands of women to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Many of those women have suffered serious transvaginal mesh complications, resulting in over 100,000 defective device lawsuits filed and potentially making the vaginal mesh one of the largest medical device mass torts ever.
In December 2015, an Indiana woman was awarded $12.5 million. A New Jersey woman was awarded a $13.5 million award in February 2016. In April 2017, a Cinnaminson woman was awarded $20 million. A Pennsylvania woman received $2.1 million in June.
Some complaints by plaintiffs involving transvaginal mesh devices include: infection, bleeding, severe pain, erosion of internal bodily tissue, dyspareunia (difficult or painful sexual intercourse), painful scarring, as well as other injuries. Plaintiffs also note that these adverse reactions require surgical removal of the device.
FDA Transvaginal Mesh Warnings
The U.S. Food and Drug Administration (FDA) issued warnings about transvaginal mesh implants as early as 2008. In 2011, the agency changed its prior notice to indicate that complications linked to transvaginal mesh were “not rare,” and indicated that transvaginal mesh does not seem to have any clear benefits for patients diagnosed with POP when compared to non-mesh methods.
The FDA indicated the most common injuries reported due to use of the transvaginal mesh are: infection, incontinence, pain, mesh erosion, recurrence of prolapse, and urinary problems. Women also reported injuries including perforation of the bowels, bladder, and blood vessels connected to the implantation of transvaginal mesh devices.
Over time, the transvaginal mesh has failed in numerous ways, often eroding through the vaginal wall or skin. This has caused severe pain and alters women’s lives who suffer from a malfunctioning transvaginal mesh. Women have described their pain in some cases, as an inability to sit, stand, or lay in a position for more than a few minutes at a time.
FDA’s 510(k) Fast-Track Approval
A number of plaintiffs remarked that the transvaginal mesh devices had been approved through the FDA’s 510(k) fast-track process. The 510(k) allows device manufacturers to bring devices to market without the stringent clinical testing normally done with new products to confirm safety and efficacy. The new device has only to show that it is “substantially equivalent” to a previously FDA approved medical device, even if that product has been voluntarily recalled.
The FDA handled these concerns by reclassifying transvaginal mesh from a moderate-risk device to a high-risk device. This means that transvaginal mesh device manufacturers have to go through the FDA’s more rigorous pre-market approval process and submit data proving their devices are safe and effective.
Advice and Information for Transvaginal Mesh Recipients
If you or someone you know suffered injuries regarding the use of transvaginal mesh implants, you may be eligible for compensation. The personal injury attorneys at Parker Waichman offer free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).