| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ALIGN URETHRAL SUPPORT SYSTEM | C.R. BARD, INC. | FTL | NA | BRD400HK | HUSF0169 | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2011-10-14 | 0 | 1. R |
Patient 1
IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, AND HAS SUSTAINED PERMANENT INJURY AND WILL LIKELY UNDERGO CORRECTIVE SURGERY.
Patient 1
THE DEVICE REMAINS IMPLANTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER FOUND NOTHING THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES EACH DEVICE STATES IN THE ADVERSE EVENTS SECTION: "COMPLICATIONS ASSOCIATED WITH THE PROPER IMPLANTATION OF THE 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." THE PRECAUTIONS SECTION STATE: "POST-OPERATIVELY THE PATIENT IS RECOMMENDED TO REFRAIN FROM HEAVY LIFTING AND/OR EXERCISE (I.E., CYCLING, JOGGING) FOR AT LEAST THREE TO FOUR WEEKS AND INTERCOURSE FOR ONE MONTH." (B)(4).
Patient 1
(B)(4). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
Patient 1
PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED URINARY URGENCY, FREQUENCY, A RECURRENT VAGINAL BULGE, WORSENING PELVIC ORGAN PROLAPSE, AND COMPLETED URODYNAMIC STUDIES TO FIND SIGNIFICANT STRESS URINARY INCONTINENCE AND A SLIGHTLY LOW BLADDER CAPACITY. ASKS TO HAVE THE MESH REMOVED. SHE DID RETURN ((B)(6) 2011) TO HAVE A ROBOTIC SUPRACERVICAL HYSTERECTOMY, CERVICAL SACROPEXY, CONCOMITANT TVT EXACT RETROPUBIC SLING AND CYSTOSCOPY, VAGINAL WALL MESH EXCISED. IT IS UNCLEAR FROM THE OP REPORT IF BOTH ANTERIOR AND POSTERIOR MESH WAS EXCISED. AFTER THIS SURGERY, IT WAS RECOMMENDED SHE TRY URETHRAL BULKING AGENTS. THERE IS NO RECORD THAT THE PATIENT RETURNED FOR THIS PROCEDURE.