Australian healthcare regulators issued a safety advisory late last month on certain lots of American Medical Systems’ AMS 800 urinary control systems, warning that the devices were released on the market on the market without meeting the company’s product release criteria.
The AMS 800 devices are part of implantable artificial urinary control systems, for use in patients with severe incontinence. The device operates via a manual control pump that uses pressure to open and close the urethra.
Certain lots of the devices may be defective, requiring increased force to manipulate or unintentionally operating when deactivated, according to the Australian Therapeutics Goods Admin. warning. The issues could lead to bruising at the site of the pump, incontinence or the inability to urinate, with potential subsequent symptoms and complications, which "can pose serious health risks," the regulators warned.
The ATGA recommended that consumers warn their doctors of any issues and that healthcare professionals refer their patients to a urologist, preferably an implanting urologist, who may recommend revision surgery.
The warning affects 2 item numbers associated with the implants, and all affected stock has been taken off the shelves, according to the ATGA.
That’s more bad news for AMS, which in November 2012 underwent a recall of its AdVance Male Sling Systems.