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).No sample received.
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The patient's attorney alleged a deficiency against the device.Per additional information received, the patient has experienced nocturia, erosion mesh, dyspareunia, foul smelling urine, renal cyst, stress incontinence, hematuria and an inr of 7.7, flank pain, incontinence, rash on her lower leg, abdominal pain (suprapubic), burning in bladder, interstitial cystitis, urinary tract infection, left flank pain, nausea, back pain (left flank), headaches, epigastric pain, allergic reaction, urticaria, pain in vaginal area, shredded glass feeling with intercourse, rib pain on left side, vaginal atrophy, stress incontinence in female, postoperative pain, vomiting, exposure of vaginal mesh through vaginal wall, scar tissue, rectus fascia, inflammation.The patient required additional surgical and non-surgical interventions.
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