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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 experienced bladder symptoms, incomplete bladder emptying, fatigue, dysuria, right lower quadrant pain, urethral pain, right inguinal area pain, acute cystitis, sparc mesh erosion into bladder with removal, suprapubic scars, candida infection, abdominal pain, pain on right side with urination, suprapubic pain, urinary frequency up to 20 times per day, urgency incontinence, groin pain when she drives, external irritation, mild erythema along the suture line of the bladder, levator myalgia, overactive bladder, muscle spasm requiring physical therapy, wakes up at night to urinate, difficulty starting urination, straining, weak urinary flow, sensation of incomplete emptying of bowels, bladder infections, vaginal scarring, bleeding and pain with vaginal penetration.Per additional information received, the patient abdominal pain, burning, dysuria, urinary frequency, urinary urgency, hematuria, infection, mesh erosion, mesh extrusion, pelvic pain, radiating pain, recurrence of stress urinary incontinence, urine leakage, left kidney pelviectasis, multiple drug resistant organism/resistant escherichia coli in urine (bacterial infection), urinary tract infection (uti), incomplete bladder emptying (urinary retention), acute cystitis (inflammation), chronic inflammation, foreign body giant cell reaction, right groin/inguinal pain, lower abdominal/urethral discomfort, fatigued, right side pain with voiding, urge incontinence, external irritation, pelvic pressure/heaviness/dullness, leukocytes/protein in urine, abdominal/pelvic floor muscle tenderness, levator myalgia (myalgia), overactive bladder, cold intolerance, nausea, suture line in bladder, muscle spasm, aching, pain with sexual intercourse, increased pelvic floor muscle tension, and required additional surgical and non- surgical interventions.Per additional information received via medical records on (b)(6) 2018, the patient has experienced incomplete bladder emptying, right lower quadrant/inguinal pain and to thigh, pressure and burning to urethra, dysuria, fatigue, urgency, mild pelviectasis of left kidney, recurrent urinary tract infections, acute cystitis, frequency, headaches, pressure and burning in the urethra, nausea, abdominal pain, atrophic vaginitis, (b)(6) 2014 cystoscopy which revealed mesh erosion in the right bladder neck, hematuria, irritated perianal skin, constipation, right suprapubic pain, pain triggered by intercourse, (b)(6) 2014 cystoscopy that reportedly revealed vicryl in the bladder, (b)(6) 2015 cystoscopy that reportedly revealed a small dimple in the bladder, transvaginal ultrasound that reportedly revealed a cystic lesion of the left ovary, pelvic pain, levator myalgia/hypertonicity, intrinsic (urethral) sphincter deficiency, recurrent stress urinary incontinence, small hole in the intestine, candida albicans infection, pudendal neuralgia, use of spinal cord stimulator complicated by infection and hospitalization, endometriosis, entrapped nerve damage, and abdominal adhesions.She has required non-surgical interventions of vaginal estrogen, vaginal valium, diflucan, antibiotics for recurrent urinary tract infections, and physical therapy with poor results.She also required surgical interventions such as excision of eroded sparc mesh ((b)(6) 2014); excision of vaginal tot mesh and cystoscopy ((b)(6) 2015); vaginal exploration, transvaginal urethrolysis, and cystourethroscopy ((b)(6) 2017); and excision of right groin mesh, excision of left groin mesh, excision of vaginal mesh, robotic-assisted laparoscopic excision of abdominal mesh, resection of endometriosis, and kelly plication of urethra ((b)(6) 2018).Per the pfs, the patient also alleged catastrophic pain syndrome, rectal pain, neuralgia, depression, ultrasound guided bilateral pudendal nerve blocks, cystocele, diabetes, pelvic tumors/fibroids, peritonitis/sepsis, urinary retention, and uterine prolapse.Per additional information received via medical record on (b)(6) 2018 the patient has experienced incomplete bladder emptying, right lower quadrant/inguinal pain and to thigh, pressure and burning to urethra, dysuria, fatigue, urgency, mild pelviectasis of left kidney, recurrent urinary tract infections, acute cystitis, frequency, headaches, pressure and burning in the urethra, nausea, abdominal pain, atrophic vaginitis, (b)(6) 2014 cystoscopy which revealed mesh erosion in the right bladder neck, hematuria, irritated perianal skin, constipation, right suprapubic pain, pain triggered by intercourse, (b)(6) 2014 cystoscopy revealed suture line along the right side of the bladder and vicryl visible with some mild erythema, cystoscopies on (b)(6) 2014 and (b)(6) 2014 with normal findings, (b)(6) 2015 ultrasound which revealed a complex cystis lesion in the left ovary, (b)(6) 2015 cystoscopy that revealed a small dimple in the bladder, pelvic pain, rectal pain, levator myalgia/hypertonicity, intrinsic (urethral) sphincter deficiency, recurrent stress urinary incontinence, small hole in the intestine, candida albicans infection, pudendal neuralgia, dyspareunia, urinary incontinence, perineal pain, adjustment disorder with mixed anxiety and depressed mood, ganglion impar block, use of spinal cord stimulator complicated by infection and hospitalization, left flank pain, slow urinary stream and intermittency, endometriosis, entrapped nerve damage, abdominal adhesions, and left leg pain.She has required non-surgical interventions of vaginal estrogen, vaginal valium, diflucan, antibiotics for recurrent urinary tract infections, vesicare, gabapentin, and cymbalta use, and physical therapy with poor results.She also required surgical interventions such as excision of eroded sparc mesh ((b)(6) 2014); trigger point injection ((b)(6) 2015), excision of vaginal tot mesh and cystoscopy ((b)(6) 2015); pudendal nerve blocks x 3, ganglion impar block ((b)(6) 2016), peripheral nerve block and right sided pudendal nerve block ((b)(6) 2016), spinal cord stimulator implantation ((b)(6) 2016), vaginal exploration, transvaginal urethrolysis, and cystourethroscopy ((b)(6) 2017); and excision of right groin mesh, excision of left groin mesh, excision of vaginal mesh, robotic-assisted laparoscopic excision of abdominal mesh, resection of endometriosis, and kelly plication of urethra ((b)(6) 2018).Per the pfs, the patient also alleged catastrophic pain syndrome, cystocele, pelvic tumors/fibroids, peritonitis/sepsis, urinary retention, and uterine prolapse.Per additional information received via medical records on (b)(6) 2022, the patient has experienced stress incontinence, mesh erosion into bladder, stress urinary incontinence, incomplete bladder emptying, acute cystitis, multiple drug resistant organisms, pelvic pain, pudendal neuralgia, lumbar radiculopathy, hirsutism, spasm, lower urinary tract symptoms, adiposity, acne, scar of skin, polycystic ovaries, low back pain, complication of internal prosthetic device, encounter for insertion of intrauterine contraceptive device, hip pain, infection or inflammation of bladder, overweight, allergy, infection of spinal cord stimulator, insomnia, dysuria, urgency, frequency, hematuria, flank pain, malaise/fatigue, hypertension, constipation, heartburn, myalgias, sensory change, depression, rectal pain, vaginal pain, groin pain, cellulitis of lower back, nausea with vomiting, dyspepsia, levator myalgia/ hypertonicity, helicobacter pylori infection, sphincter deficiency, microscopic hematuria, gastroesophageal reflux disease, anemia, genitourinary disease, anxiety, headache, high blood pressure, high cholesterol, pruritus ani, hemorrhage of rectum and anus, dermatophytosis of groin and perianal area, hypovitaminosis d, migraines, hyperlipidemia, reflux esophagitis, candida albicans infection, atrophic vaginitis, vaginal discharge and required additional surgical and non-surgical interventions.
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