American Medical Systems (AMMD), a medical device manufacturer based in Minnetonka, Minnesota, announced the recall of its AdVance Male Sling system. According to reports from the company, the absorbable sutures found in the sling assembly degrade before their shelf expiration date.
The sutures found in the AdVance Male Sling system have an estimated shelf life of 15 months. However, a report showed that the sutures would become brittle before this 15 month period. Since these sutures must remain supple and flexible for use in surgery, the premature degradation of these sutures could be problematic for healthcare providers and patients. However, the company has stated that the affected devices do not pose a significant risk to patients.
American Medical Systems manufactures devices for female and male pelvic health. The company’s flagship product, the Advance Male Sling system, is specifically designed for men who are experiencing urinary incontinence. The device is used to restore bladder control after surgery.
According to the company, an internal AMS investigation led to the discovery of the faulty sutures. Lots 722024001 to 790226012 contain units that degraded before the end of their expected shelf life. The company was unable to confirm if other units in these lots also have this problem. Because of this, AMS is asking its customers to return all AdVance sutures in the above lot numbers.