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: ¿the pelvilace¿ biourethral support system is for single-patient use only and is to be implanted surgically.Do not use the pelvilace¿ biourethral support system if the integrity of the packaging appears compromised.The pelvilace¿ biourethral support system pelvicol® implant should be hydrated or moist when the package is opened.Dehydrated or dry tissue should not be implanted.Postoperative retropubic bleeding may occur in some patients and must be controlled prior to patient release.The pelvilace¿ biourethral support system procedure requires diligent attention to anatomical structure and care to avoid puncture of large vessels, nerves, bladder, and bowel, during needle passage.Proper placement of the pelvilace¿ biourethral support system at mid-urethra requires that the tissue lie flat with minimal or no tension under the urethra.The pelvilace¿ biourethral support system is intended as a single-use, disposable device.Do not resterilize any portion of the pelvilace¿ biourethral support system.Patients should be advised that pregnancy following an pelvilace¿ biourethral support system procedure may negatively affect the success of the previous procedure and incontinence may reoccur.The safety and effectiveness of pelvilace¿ biourethral support system has not been established for the treatment of stress urinary incontinence in males and children under the age of 18.¿ (b)(4).
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The patient's attorney alleged a deficiency against the device.It was reported by the patient¿s attorney that as a result of having the product implanted, the patient has experienced stress urinary incontinence, mesh exposure, depression, vaginal and bladder infections, inability to hold bladder, painful intercourse, leakage, left groin abscess, vaginal pain, pain to left lower quadrant of abdomen and groin area, dysuria, vaginal discharge, fibroids, partial hysterectomy, incarcerated hernia, left rectus sheath hematoma, depression, anxiety, urine incontinence secondary to bowel dysfunction, mixed urinary incontinence, flow incontinence, frequency, paralytic ileus, exploration of left groin with excision of mass and incision and drainage of abscess, chronic granulation tissue in vagina, draining sinus in the intra-abdominal wall, removal of old pelvilace material, closure of anterior vaginal wall after debridement of granulation tissue and closure of the urethra, intrinsic sphincter deficiency and injection of bulking agent.She required multiple nonsurgical and surgical interventions.
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