Vaginal Mesh Helpline ,Ladies of the Vaginal Mesh Announcement: If appears that there has been an official recall of one of the Vaginal mesh Implants.
Boston Scientific issued a Class II recall of its Pinnacle pelvic floor repair kit over the potential for the needle to detach from the mesh during placement. The device may expose patients to unnecessary risk without offering clinical benefit above safer options.
The product is used to treat pelvic organ prolapse, which occurs when internal organ support structures become so weak or stretched that organs, like the uterus, bladder or bowels, sag from their normal position and bulge or prolapse into the vagin
See the Fda Notice Below
Class 2 Recall
Pinnacle Pelvic Floor Repair Kit–Anterior/Apical, and Pinnacle Pelvic Floor Repair Kit–Posterior see related information
Date Posted August 03, 2011
Recall Number Z-2931-2011
Product Pinnacle Pelvic Floor Repair Kit–Anterior/Apical STERILE, and Pinnacle Pelvic Floor Repair Kit–Posterior STERILE. Boston Scientific, Corp. Indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor for vaginal wall prolapse, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
Code Information Catalog/UPC: M0068317100, Lot: 1ML0072001. Catalog/UPC M0068317050, Lot: 1ML0070801.
Manufacturer Boston Scientific Corporation
100 Boston Scientific Way
Marlborough, Massachusetts 01752-1234
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Cindy Finney
Recall The device may exhibit low tensile strength between the needle and suture and lead to needle detachment during mesh leg placement.
Action Boston Scientific Corporation sent on May 10, 2011 an "URGENT MEDICAL DEVICE RECALL-IMMEDIATE ACTION REQUIRED" letter to all affected customers. The letter included; reason for recall, instructions for the quarantine, discontinued use, and return of the devices, and information for Medwatch reporting. The letter also includes a form that is to be faxed to the firm. For information call (508) 683-4678
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