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¿ to 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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It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced injury, pain, disability and impairment.Per additional information received, the patient has experienced erosion, mesh protruding into vaginal wall, vaginal bleeding, pelvic pain, pain with intercourse, urinary tract infections, vaginal discharge, unspecified urinary problems, urinary retention, blood loss, discomfort, unspecified problems with sex life, cystocele/rectocele (prolapse), nonsurgical and additional surgical interventions.Per additional information received, the patient has experienced discomfort, left side pain, posterior vaginal mesh erosion, distal rectocele, stress incontinence with intrinsic sphincter deficiency, mesh contracture, bleeding, approximately 4-5 cm mesh was dissected.The patient required additional surgical interventions.
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