The fate of transvaginal meshes is still a question mark. The popularity of the defective medical devices appears to be diminishing and several lawsuits concerning them continue to be filed or transferred to the vaginal mesh MDL (multidistrict litigation) in West Virginia. The lawsuits are against manufacturers such as Boston Scientific, Ethicon, American Medical Systems and C.R. Bard.
The devices were introduced in the 1990s to permanently resolve POP (pelvic organ prolapse) conditions that usually affect older women after menopause, a hysterectomy or childbirth. The synthetic mesh which is like a hammock would be surgically implanted through the vagina or transvaginally to support the prolapsed organs. The device, initially thought advantageous, is now known nationwide to be associated with complications such as erosion and organ perforation.
Though the FDA has issued safety warnings about the devices, it has so far not called for them to be taken off the market. However, the administration’s proposed rule pertaining to a Unique Device Identifier (UDI) is expected to help identify and quickly resolve problems related to medical devices. The proposed rule was the administration’s response to a Congress legislation of 2007 directing them to develop rules that created a unique device identification scheme for medical devices.
Ethicon Could Be in Trouble
Ethicon faces the charge selling Gynecare Prolift for three years without approval from the FDA, according to a Bloomberg report. In 2007, the FDA actually ordered Ethicon to take its product off the shelves while it investigated whether or not the Gynecare Prolift was safe. The manufacturer, however, openly disregarded the demand and continued selling the transvaginal mesh implant.
Ethicon claimed that the Gynecare Prolift was “substantially equivalent” to its FDA approved Gynemesh device. FDA had to look into the case in more detail following numerous complaints from patients.
Last month, there was a fresh development pertaining to the pending Ethicon vaginal mesh lawsuit mass tort in the New Jersey Superior Court. The judge asked Ethicon, a subsidiary of Johnson & Johnson, to reveal its correspondences with the FDA regarding the safety of its Gynecare transvaginal mesh products. Johnson & Johnson would also be forced to reveal its post-market studies.
With such data exposed, transvaginal mesh attorneys and the women they
represent would have more proof supporting the statement that the manufacturer
was aware its product was faulty and unsafe and yet kept selling it. It
would show that the manufacturer considered its own profits more important
than its customers. This summer, Johnson & Johnson declared it would
stop selling its Gynecare line, which included the Prolift, Prolift+ M,
TVT Secur and Prosima.
In the midst of all the lawsuits going out against vaginal mesh implant manufacturers, a frightening revelation has come out that sellers of the defective medical devices were trying to get their product sold to unwary customers using the medium of eBay.
Some Good News for Victims
Late last month, two rulings from a federal judge supervising the MDL brought good news to women who have been victim to the complications of the vaginal mesh. The first order would give more time to plaintiffs associated with vaginal mesh implant lawsuits directed at C.R. Bard. The lawsuits expected to start in February 2013 are currently scheduled for June 24, 2013. The victims of the company’s faulty product thus have more time to sue. A competent defective medical device attorney can help successfully fight a pelvic mesh case.