Johnson & Johnson is withdrawing Gynecare TVT pelvic mesh devices manufactured by its Ethicon, Inc. subsidiary from the Australian market, after the company failed to meet a deadline for updating the products’ “instructions for use” set by that country’s medical device regulator.
The move comes as more than 700 Australian women – and tens of thousands of others throughout the United States – pursue transvaginal mesh lawsuits that seek compensation for injuries and complications allegedly associated with Ethicon’s pelvic mesh implants.
According to the Guardian, the Australian Therapeutics Good Administration (TGA) had asked all transvaginal mesh manufacturers to update their products’ “instructions for use” with new adverse event information – including severe chronic pain, groin pain and bladder perforation – by January 17th.
Johnson & Johnson did not meet that deadline and its Gynecare TVT implants no longer appear on the TGA’s register of products that can be lawfully supplied in Australia.
A spokesperson for Johnson & Johnson told BuzzFeedNews that the products were placed “on hold” due to the TGA’s new rules.
“The company is assessing the new requirements and the global regulatory implications,” the spokesperson said. “Importantly, this is not a product recall and no action is required by patients who have received TVT products. No new orders will be shipped to customers.”
In June 2012, Johnson & Johnson and Ethicon announced it would no longer sell four Gynecare pelvic mesh products in the U.S., including Prolift, Prolift+M, TVT Secur and Prosima mesh.
Transvaginal mesh devices are implanted in women who suffer from pelvic organ prolapse and stress urinary incontinence. In addition to Ethicon, other pelvic mesh manufacturers include American Medical Systems, Inc., Boston Scientific Corp., Cook Medical, Inc. and Coloplast Corp.
Since 2008, the U.S. Food & Drug Administration (FDA) has issued several warnings regarding the serious and life-changing adverse events that may occur following implantation of transvaginal mesh, including mesh erosion, scarring and adhesions, chronic pain, infections, and organ damage. In 2011, the agency retreated from its earlier position that complications associated with transvaginal mesh prolapse repair were a rare occurrence.
Just last year, the FDA reclassified transvaginal mesh implants indicated for use in pelvic organ prolapse surgery as high-risk medical devices. Among other things, the reclassification made those implants ineligible for the agency’s 510(k) clearance program, which does not require a device to undergo human clinical trials before coming to market.
Tens of thousands of women throughout the United States have since filed transvaginal mesh lawsuits against Ethicon and other pelvic mesh manufacturers. Of 32 cases that have gone to trial, 23 have concluded with verdicts for the plaintiffs and damage awards in excess of $1 million.
The most recent trial involving Ethicon ended in December, with a New Jersey Superior Court jury awarding $15 million in compensatory and punitive damages to a woman who was implanted with Gynecare TVT-O mesh.