The sample was not returned.The finished product met all specifications prior to being released for general distribution.The instructions for use which accompanies all devices currently addresses potential risks associated with surgically implanted materials.The instructions for use states in the adverse events: "complications associated with the proper implantation of the align¿ urethral support system may include, but are not limited to: postoperative hematoma, which may occur following the implant procedure.Temporary urinary retention, bladder outlet obstruction, and voiding difficulties associated with over-correction/too much tension placed on the mesh sling implant.Perforations or lacerations of vessels, nerves, bladder or any viscera, which may occur during introducer needle passage.Transitory irritation at the operative wound site, which may elicit a foreign body response that leads to inflammation, infection, or erosion of the implant." (b)(4).
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Per additional information received on (b)(6) 2021, the patient has experienced mesh erosion, urethrovaginal fistula, intrinsic sphincter deficiency, low pressure urethra, recurrent female stress urinary incontinence, sling complication with calculus formation, essential hypertension, unspecified hyperlipidemia, chest pain, esophageal reflux, migraine, urinary frequency, occasional urgency, overactive bladder problems, urge incontinence, hypertonicity bladder, nocturia, urinary leakage, dryness of mouth, dribbling, incomplete bladder emptying sensation, occasional hematuria, occasional urinary hesitancy, thyroid problems, arthritis, severe back pain, depression, site unspecified urinary tract infection, abdominal pain, cyst of kidney, heart palpitations, herpes genitalis, irritable bowel syndrome, malignant neoplasm of breast, lower abdominal cramps, vomiting, anxiety, bowel incontinence, impacts quality of life, suprapubic pain, hemorrhoids, anemia, post-traumatic stress disorder, suicidal ideation, hallucinations, dysfunctional uterine bleeding, sore throat, lumbar back pain, left buttock pain, leg pain, shortness of breath, left bloody nipple discharge, fibrocystic disease of breast, knee pain and required additional surgical and non-surgical interventions.
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