IDEAL IMPLANT STRUCTURED BREAST IMPLANT
Report
- Report Number
- 3011491947-2016-00003
- Event Type
- Injury
- Date Received
- February 6, 2016
- Date of Event
- October 31, 2015
- Report Date
- April 9, 2019
- Manufacturer
- IDEAL IMPLANT
- Product Code
- FWM
- UDI-DI
- 10851795006060
- PMA / PMN Number
- P120011
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
THE FOLLOWING UPDATES WERE MADE TO THE REPORT: ADVERSE EVENT, OUTCOMES ATTRIBUTED TO ADVERSE EVENT, DATE OF THIS REPORT, MANUFACTURER NAME, CITY AND STATE, INITIAL REPORTER NAME, CONTACT OFFICE - NAME/ADDRESS/PHONE NUMBER, REPORT SOURCE, TYPE OF REPORT, TYPE OF REPORTABLE EVENT, IF FOLLOW-UP, WHAT TYPE, UNCHECKED EVALUATION SUMMARY ATTACHED, EVENT PROBLEM AND EVALUATION CODES, AND ADDITIONAL NARRATIVES/DATE. EVALUATION SUMMARY WAS REMOVED AS AN ATTACHMENT. THE EVALUATION SUMMARY IS AS FOLLOWS: NO DEFECT WAS FOUND ON MACROSCOPIC OR MICROSCOPIC EXAMINATION OF THE EXPLANTED DEVICE, AND THE ALLEGED LEAK COULD NOT BE DUPLICATED. A PLUG OF WHAT APPEARED TO BE CLOTTED BLOOD WAS LODGED IN THE ANTERIOR VALVE, WHICH COULD AFFECT THE VALVE SEAL AND EXPLAIN A SLOW LEAK OF THE OUTER LUMEN AND DEFLATION.
DEFLATION RESULTING IN EXPLANTATION.
IDEAL IMPLANT DID NOT SUBMIT THIS MDR WITHIN 30 DAYS OF BECOMING AWARE OF THE INCIDENT FOR THE FOLLOWING REASONS. PER THE FDA REGULATIONS FOR REPORTABLE EVENTS, A SERIOUS INJURY IS ONE THAT: IS LIFE THREATENING, RESULTS IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, OR NECESSITATES MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. PER THE DEFINITION NOTED ABOVE, IDEAL IMPLANT INCORPORATED UNDERSTOOD THAT A COMMON SALINE BREAST IMPLANT DEFLATION WOULD NOT FALL WITHIN THE DEFINITION OF SERIOUS INJURY AND WOULD THEREFORE NOT BE CONSIDERED REPORTABLE. ALTHOUGH SURGICAL INTERVENTION MAY BE PERFORMED TO REMOVE AND/OR REPLACE THE BREAST IMPLANT, IT IS NOT MEDICALLY REQUIRED TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. IMPLANTS ARE FILLED WITH NORMAL SALINE, WHICH IS HARMLESSLY ABSORBED BY THE BODY. A DEFLATION POSES MINIMAL RISK TO THE PATIENT AND IS NOT CONSIDERED SERIOUS IN THE ABSENCE OF AN ADDITIONAL SERIOUS CONDITION, SUCH AS EXTRUSION, TISSUE NECROSIS, SEPSIS, LYMPHOMA (ALCL), NEUROLOGIC PROBLEM, BREAST MASS, POSSIBLE AFFECT ON FETUS, ETC. BECAUSE A DEFLATION, ABSENT OF AN ADDITIONAL SERIOUS PATIENT CONDITION, DOES NOT POSE RISK TO THE PATIENT OF DEATH OR SERIOUS INJURY, IDEAL IMPLANT DID NOT CONSIDER DEFLATION OR SURGERY TO REMOVE A DEFLATED IMPLANT TO BE A "SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE." A DEFLATION OR OTHER TYPE OF DEVICE MALFUNCTION, IN WHICH A SERIOUS INJURY, SERIOUS CONDITION OR DEATH IS REPORTED AS A CONSEQUENCE, WOULD BE CONSIDERED REPORTABLE. HOWEVER, DURING A RECENT FDA INSPECTION PERFORMED 2/1/2016-2/3/2016, AN OBSERVATION WAS MADE THAT THIS DEFLATION SHOULD HAVE BEEN REPORTED TO THE FDA. UPON LEARNING THAT FDA CONSIDERS ANY DEFLATION THAT WAS EXPLANTED TO BE REPORTABLE, IDEAL IMPLANT BEGAN SUBMITTING REPORTS FOR PAST DEFLATIONS AND WILL CONTINUE TO REPORT ALL INSTANCES OF EXPLANTED DEFLATIONS IN THE FUTURE.
DEFLATION RESULTING IN EXPLANTATION.
DEFLATION RESULTING IN EXPLANTATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 73395 | IDEAL IMPLANT STRUCTURED BREAST IMPLANT | SALINE-FILLED BREAST IMPLANT | FWM | IDEAL IMPLANT | 40501 | 61042 | 10851795006060 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Required Intervention |