It was reported to boston scientific corporation that a upsylon y-mesh was implanted into the patient on (b)(6) 2017.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: back pain; vaginal pain; pelvic pain; groin pain; perineum pain; thigh pain; inability to have intercourse; difficulties with bowel motions; incontinence not present before implant.Surgical interventions: on (b)(6) 2018 the patient underwent further surgery regarding the upsylon y-mesh implant under general anesthesia for the following purpose: remove mesh that had detached from vaginal wall and attach new mesh (restorille), leaving upsylon tail in position.On (b)(6) 2021 the patient underwent further surgery regarding the upsylon y-mesh implant under general anesthesia for the following purpose: remove all mesh.Also do anterior and posterior repairs.Nonsurgical treatments: on (b)(6) 2017 the patient commenced topical treatment (including oestrogen cream): ovestin for purpose: replace oestrogen.Treatment duration: 15 months.On (b)(6) 2018 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for purpose: improve pelvic floor.Treatment duration: once.On (b)(6) 2019 the patient commenced pain medication: endep for purpose: relieve pelvic, vaginal and abdominal pain.Treatment duration: 2 yrs 8 months.On (b)(6) 2019 the patient commenced topical treatment (including oestrogen cream): vagifem for the treatment of: replace oestrogen.Treatment duration: 2 yrs 7 months.On (b)(6) 2019 the patient commenced injections (not associated with surgical treatment): platelet rich plasma (prp) for purpose: relieve pain.Treatment duration: 1 yr 7 months.On (b)(6) 2019 the patient commenced other (please specify) for purpose: relieve pain.Treatment duration: 1 yr 7 months.On (b)(6) 2020 the patient commenced pain medication: pea capsules for purpose: relieve pelvic, vaginal and abdominal pain.Treatment duration: 1 yr 8 months.On (b)(6) 2021 the patient commenced topical treatment (including oestrogen cream): ovestin for the treatment of: replace oestrogen.Treatment duration: ongoing.
|
(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.
|