Boston Scientific sent an “Urgent Medical Device Recall” letter to customers who used the Pinnacle® Pelvic Floor Repair Kit for tissue reinforcement for pelvic organ prolapse (POP). In May, Boston Scientific issued a Field Safety Notice to healthcare professionals recalling 2 specific lots, citing the reason for recall as “low tensile strength between the needle and the suture, which could potentially lead to needle detachment during mesh leg placement.” According to the manufacturer, if needle detachment occurred, the user had the option of leaving the needle or having it removed. However, if retrieval is attempted, further complications (i.e. tissue trauma/perforation) may occur.
Approximately 540 Pinnacle® Pelvic Floor kits have been distributed.
The FDA’s Medical Device Recalls Database did not post this recall until August 3, 2011.
An FDA advisory panel is scheduled to meet next month to review the safety of trans vaginal mesh devices in the treatment of pelvic organ prolapse and make recommendations on how the regulatory agency should proceed.