Note: two boston scientific mesh devices were implanted in the same patient.This report pertains to the upsylon y-mesh.It was reported to boston scientific corporation that an upsylon y-mesh and an advantage fit were implanted into the patient on (b)(6) 2016.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; perineum pain; other pain: sharp stabbing pain in ovaries; painful intercourse; difficulties with bowel motions; recurrent incontinence.Surgical interventions: on unspecified dates the patient underwent further surgery under general anesthesia for the following purpose: botox injections - for 2-4 years (every 6-9 months).
|
(b)(6).The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.The complainant indicated that the device is not available for return; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
|