AMS Advance Male Sling System Recalled
Customer complaints prompted American Medical Systems Europe BV to recall some lots of its Advance Male Sling System because the absorbable sutures in the medical device may degrade before the end of its shelf life.
The sutures in the faulty devices may become weak and give way when bent before surgery, despite a fifteen-month shelf life, reports Mass Device. Also, they may not give desired results post surgery if the sutures have degraded.
The company designs products for pelvic health care in men and women and the device in question is used by men undergoing mild stress urinary incontinence and is used to help regain post-operative bladder control, stated the AMS website.
The company’s in-house analysis showed premature degradation in some sutures. The company has asked consumers to return products belonging to lot 722024001 to 790266012, reports Mass Device.
AMS stated that there is very little risk to patients with the device implanted.