Bellwether Transvaginal Mesh Case. Jury selection has begun in the case of one woman who claims the transvaginal mesh device she received in a surgery was defective and caused her to suffer serious and permanent injuries.
This is the first case involving product liability claims against the maker of a transvaginal mesh device and, according to a report from MassDevice.com, the bellwether case is likely to have major ramifications for the hundreds of other lawsuits already filed against makers of these devices.
There have already been at least hundreds of similar lawsuits filed in courts across the country in which women claim that the transvaginal mesh device they received in a surgery to repair or treat their bouts with stress urinary incontinence and/or pelvic organ prolapse. This is the first to reach a jury trial.
In each claim, a woman believes that the makers of the specific device named in the lawsuit knowingly hid evidence that its products were dangerous or they did not perform any pre-market testing to determine if they were safe or effective for use.
This case, to be heard in a Maryland court, involves the Ethicon Prolift device
This case, to be heard in a Maryland court, involves the Ethicon Prolift device. The Plaintiff, Linda Gross, claims she received the Prolift device in a surgery to treat one or both of those approved indications but was never warned about the potential complications that could result.
She was never told that the transvaginal mesh device she would receive in the procedure and almost every other available transvaginal mesh device had never undergone any pre-market testing that could prove it was safe or effective in the treatment of those conditions.
Transvaginal mesh devices were largely approved through the Food and Drug Administration’s dubious 510(k) “fast-track” approval system that grants clearance to medical devices that are similar in design to a previously-approved device.
Surgical mesh has been used in other procedures for years but never before in the treatment of these conditions. But to get the Prolift and other devices approved, its manufacturer, Johnson & Johnson subsidiary Ethicon, needed only show that the Prolift was similar to other surgical mesh products.
This process alleviates the “burden” of having to conduct costly pre-market testing before a device can be approved for use by the FDA. The system has come under great scrutiny in the last few years, mainly due to the wide-range failures of transvaginal mesh and other products rushed through the system like metal-on-metal hip implants.
Last year, the FDA admitted that injuries and complications caused by transvaginal mesh devices were “not rare” and it had already ordered more than 30 manufacturers of these devices to conduct post-market testing to prove they were effective. Since then, some makers have stopped marketing their devices, including Ethicon and the Prolift device.
The woman involved in the Maryland case claims that her Prolift device caused her to suffer severe pain and permanent injuries.