Johnson & Johnson Has Withdrawn The Mesh Products It Is Being Sued Over
Thousands of Australian women have been implanted with Johnson & Johnson mesh devices since 2000.
Johnson & Johnson has withdrawn from the market controversial devices at the centre of a class action against the pharmaceutical giant.
The Therapeutic Goods Administration (TGA) requested last year that all manufacturers of transvaginal sling and mesh update product information on the devices by January 17 to include warnings about potential adverse side effects.
A spokesperson for the authority today confirmed to BuzzFeed News that Johnson & Johnson missed this deadline and had withdrawn the supply of its mid-urethral sling devices "to consider their options in response to TGA’s request to update the Instructions for Use of their products".
The devices will no longer be imported while the company weights up its options.
Urogynaecological meshes, sometimes known as transvaginal meshes, are inserted into women as a treatment option for pelvic organ prolapse (when the connective tissue securing the vagina and uterus to the pelvis gives way after childbirth), or urinary incontinence.
The products, known as Gynecare TVT, are the subject of a class action involving 700 Australian women.
The women are currently in court fighting Ethicon, a subsidiary of Johnson & Johnson, in a class action brought by Shine Lawyers claiming vaginal medical devices left women "suffering painful and life-altering complications".
A Johnson & Johnson spokesperson said the products were placed "on hold" in Australia and New Zealand on January 17 due to the TGA's new warning 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."
Shine Lawyers estimates there could be upwards of 8,000 Australians who have been implanted with one of the nine devices in question.
Shine Lawyers would not talk to BuzzFeed News about the latest development, as the matter is still before the courts. The firm's lawyers will make closing submissions on the case next week.
Johnson & Johnson said the company's pelvic mesh products had been developed in "close consultation with specialist surgeons" and were "backed by years of clinical research".
Last month New Zealand's Ministry of Health told leading suppliers of transvaginal mesh products to prove the implants are safe or stop marketing them.
"The [New Zealand Medicines and Medical Devices Safety Authority] response is effectively a limit on the supply of mesh for the repair of pelvic organ prolapse and stress urinary incontinence," the authority said in a statement.
The TGA also cancelled single incision mini-slings to treat stress urinary incontinence due to evidence the risks to women outweighed the benefits.
An Australian Senate inquiry into transvaginal meshes is expected to report back next month.
In its submission to the Senate inquiry, Johnson & Johnson said the use of implantable mesh was supported by clinical research and was often the preferred option to treat pelvic conditions, including incontinence and pelvic organ prolapse.
The inquiry was established to find out exactly how many women have had transvaginal mesh implants and, of those, how many experienced adverse side effects.
Queensland associate professor of urogynaecology Christopher Maher has estimated more than 200,000 mesh implant surgeries have been performed in Australia to date.
More than 100 women have written to the inquiry — here are the most heartbreaking submissions.
A list of pharmaceutical companies that did update their product information, and will continue to import and sell mesh devices in Australia, can be found here.