It was reported to boston scientific corporation that a upsylon y-mesh was 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); vaginal pain; pelvic pain; groin pain; anal pain; thigh pain; painful intercourse; difficulties with bowel motions.Surgical interventions: on (b)(6) 2019 the patient underwent further surgery regarding the upsylon y-mesh implant under general anesthesia for the following purpose: vaginal excision of small amount of mesh and vaginal repair + bilateral sacrospinous fixation.Nonsurgical treatments: on (b)(6) 2019 the patient commenced topical treatment (including oestrogen cream): ovestin cream for the treatment of: alleviate pain in sacrospinous sutures.Treatment duration: as required.
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(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.
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