Patient id: (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), 2014.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: back pain; pelvic pain; thigh pain; painful intercourse; inability to have intercourse; difficulties with bowel motions; incontinence not present before implant; recurrent incontinence; aggravated incontinence; damage surgical interventions: on (b)(6), 2015 the patient underwent further surgery regarding the upsylon y-mesh implant under general anesthesia for the following purpose: bowel prolapse.On (b)(6), 2015 the patient underwent further surgery regarding the upsylon y-mesh implant under general anesthesia for the following purpose: robotic surgery - rectal prolapse + haemorrhoidal prolapse.Nonsurgical treatments: on (b)(6), 2010 the patient commenced incontinence medication: betmiga for the treatment of: incontinence.Treatment duration: ongoing - constant.The patient was treated with topical treatment (including oestrogen cream): vagifem pessary for the treatment of: used this treatment but was too painful to continue using.Treatment duration: short-term.
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