The patient¿s attorney alleged a deficiency against the device.Additional information has been requested, but not yet received.Product was used for therapeutic treatment.Per additional information received, the patient has experienced depression, blood loss, pain in legs, right groin swelling, vaginal discharge, sensation of mesh coming out, vaginal pressure, tenderness, pain with sexual intercourse, palpable mesh, discomfort, urine leakage, sensation of a ¿bubble¿ in vagina, vaginal pain, bacilluria (bacterial infection), cystocele, dryness, urinary tract infection (uti), dysuria, mixed/urge/stress incontinence, palpable band of fibrous tissue (fibrosis), scar tissue, urinary frequency, burning sensation during intercourse, nocturia, back pain, night sweats, eroded mesh, mesh embedded in bladder (foreign body in patient), chronic inflammation, foreign material, foreign body giant cell reaction (foreign body reaction), vaginitis/vulvovaginitis, femoral hernia (hernia), and required additional surgical and non-surgical interventions.Per additional information received, the patient has experienced erosion of transvaginal mesh, pain, infection, unspecified urinary problems, recurrence, dyspareunia (pain) and required additional surgical interventions.Per additional information received via medical record on november 26, 2018, the patient has experienced pain, tenderness, dyspareunia, erosion, discharge, infection, dropped bladder, foreign body in patient, mixed incontinence, foreign body sensation, pelvic pain, inflammation, nerve damage, pain with sitting, nocturia, sleep disturbance, pressure while urinating, irritable bowel syndrome, chronic diarrhea, pelvic trauma, throbbing/stabbing vaginal pain, vaginal discharge, urinary retention, uterine prolapse, unspecified urinary problems, recurrence, cramping, muscle spasms, depression, elevated blood pressure, blood loss, chills, vaginal pain, burning sensation, night sweats, dysuria, leukocytes in urine, bladder neck hypermobility, foreign body reaction, vaginitis/vulvovaginitis, hernia, swelling, cystocele (prolapse), vaginal dryness, induration, pressure, discomfort, leakage, scar tissue, urinary tract infection, bacilluria, groin pain, nonsurgical and additional surgical interventions.Per additional information received via medical records on 04may2021, the patient has experienced mesh erosion, vaginal pain, burning on intercourse, dysuria, and yellowish discharge, painful urination, urinary frequency, dryness, extensive fibrosis, inflammation, focal fibrinoid necrosis, tenderness, dyspareunia, infection, reemerging incontinence, chronic pelvic pain, thoracic pain, vaginal stenosis, mixed urge and stress incontinence, vaginal discharge, knee pain, hip pain, right and left characterized as sharp pain, shooting pain, aching aggravated by walking, standing, joint pain.Back pain, achy in nature, constant, sharp, throbbing, located in the cervical, thoracic, and lumbar region on the right, left and midline, aggravated by activity, bending, lifting.Leg pain achy in nature, constant, sharp, shooting, located in the left and right upper and lower leg, aggravated by activity, mild vaginal atrophy, unspecified vaginitis and vulvovaginitis, epigastric pain, esophageal reflux, atrophic gastritis, diaphragmatic hernia, diarrhea, coronary artery disease, dysphagia, flatulence, mild antral gastritis, mild bile reflux, facet joint syndrome and required additional surgical and non-surgical interventions.
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