(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 an upsylon y-mesh was implanted on (b)(6) 2017.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; pelvic pain; groin pain; anal pain; rectal pain; inability to have intercourse; difficulties with bowel motions; incontinence not present before implant; recurrent incontinence surgical interventions: on (b)(6) 2021 the patient underwent further surgery regarding the upsylon y-mesh implant under general anesthesia for the following purpose: investigation relating the mesh being in patient's vagina.Nonsurgical treatments: on (b)(6) 2018 the patient commenced pain medication (specific type unknown) to assist with pain in the vagina and anal passages.Treatment duration: 3 months.On (b)(6) 2019 the patient commenced physiotherapy treatment (including pelvic floor exercises or training): internal physio to alleviate pain.Treatment duration: 2 months.On (b)(6) 2017 the patient commenced topical treatment (including oestrogen cream): ovestine to thicken vagina walls.Treatment duration: 4 years.
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