(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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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); pelvic pain; difficulties with bowel motions; incontinence not present before implant.Surgical interventions: on (b)(6) 2019 the patient underwent further surgery regarding the upsylon y-mesh implant under general anesthesia for the following purpose: repair posterior vaginal compartment, sacrocolpopexy, cystoscopy.Nonsurgical treatments: on (b)(6) 2017 the patient commenced other medication (please specify): vagifem for the treatment of: assist in keeping the vaginal walls supple.Treatment duration: ongoing.On (b)(6) 2016 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: exercises to relieve lower back/ pelvic pain.Treatment duration: 6 weeks.
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