The Full Federal Court said more than 90,000 of the implants had been supplied in Australia.
The four products that remain on the market – the Gynecare Tension-free Vaginal Tape System, Gynecare TVT Obturator System, Gynecare TVT Exact Continence System and Gynecare TVT Abbrevo Continence System – are the subject of detailed, court-ordered consumer warnings. All are used to treat female stress urinary incontinence.
The terms of the court-ordered warning include that the products are “designed to and will” elicit an acute inflammatory reaction followed by a chronic inflammatory response for as long as the implant remains in the patient’s body, and in some cases that will produce “adverse effects”.
Potential side effects include infections; erosion of the mesh into the vaginal canal, which may cause pain and difficult-to-treat infections; erosion of the mesh into surrounding organs including the bladder, urethra and rectum, which may lead to pain and damage to those organs; nerve damage; incontinence; and chronic pain.
The complications are “not rare” and removing the implant may be difficult and may not alleviate the problem, the warning says. Removal may also cause further scarring and tissue damage.
