INSPIRA TEXTURE COHESIVE SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2022-05046
- Event Type
- Injury
- Date Received
- July 6, 2022
- Report Date
- August 30, 2022
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- UDI-DI
- 10888628030688
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. THE EVENTS OF INFECTION AND CAPSULAR CONTRACTURE ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: SWELLING, PAIN, DEFORMITY, HARDENING, CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN, FEVER, IMMEDIATELY HOSPITALIZED WITH A SERIOUS INFECTION AND BILATERAL SWELLING OF THE BREAST WALL, SIGNIFICANT BREAST PAIN.
FURTHER INVESTIGATION SUMMARY: WITH THE INFORMATION COLLECTED DURING THE INVESTIGATION, THERE IS ENOUGH EVIDENCE TO SUPPORT THAT DEVICE LOT NUMBER 2961172 WAS MANUFACTURED UNDER CONTROLLED CONDITIONS IN ACCORDANCE WITH ABBVIE¿S PROCEDURES. SEAL STRENGTH RESULTS WERE ACCEPTABLE. ENVIRONMENTAL MONITORING RESULTS WERE FOUND TO BE ACCEPTABLE AND THEY CONFIRMED THAT THERE WAS NOT AN ADVERSE IMPACT ON ENVIRONMENTAL CONDITIONS, DEVICE QUALITY OR PERFORMANCE. ONE ADDITIONAL COMPLAINT WAS NOTED FOR DEVICES STERILIZED UNDER STERILIZATION RUN 30024442. HOWEVER, IT IS UNLIKELY THAT THE EVENTS RELATED TO THE REPORTED INFECTION ARE ASSOCIATED TO THE STERILIZATION METHODS UTILIZED. THE TERMINAL STERILIZATION CYCLE USED BY ABBVIE WAS DEVELOPED AND VALIDATED TO ACHIEVE A HIGH LEVEL OF STERILITY ASSURANCE. THE STERILIZATION CYCLE HAS BEEN VALIDATED TO ASSURE THAT THE CHANCE OF A NON-STERILE DEVICE IS LESS THAN ONE IN A MILLION. DURING THE TREND REVIEW OF ALL INFECTION COMPLAINTS FOR THE PERIOD OF (B)(6)2020 THROUGH (B)(6)2022, NO ADVERSE TREND WAS NOTED. GIVEN THE FACT THAT THE CAUSE OF THE INFECTION CANNOT BE SPECIFICALLY ASSOCIATED TO THE MANUFACTURING PROCESS, AND THERE IS NOT AN ADVERSE TREND FOR THIS TYPE OF EVENT NO CORRECTIVE ACTION IS DEEMED NECESSARY AT THIS TIME.
PATIENT REPRESENTATIVE REPORTED THAT THE PATIENT EXPERIENCED SWELLING, PAIN, DEFORMITY, HARDENING, CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN, FEVER, IMMEDIATELY HOSPITALIZED WITH A SERIOUS INFECTION AND BILATERAL SWELLING OF THE BREAST WALL, SIGNIFICANT BREAST PAIN AND "BOTH IMPLANTS WERE TEXTURED FROM INFORMATION AND BELIEF, WHICH FROM INFORMATION AND BELIEF WERE ALSO RECALLED IN THE LATER RECALL BY THE FDA." THE REPORTED EVENTS OF LUMPS AND BODY ACHES HAVE BEEN DEEMED NOT RELATED TO THE DEVICE. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
PATIENT REPRESENTATIVE REPORTED THAT THE PATIENT EXPERIENCED SWELLING, PAIN, DEFORMITY, HARDENING, CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN, FEVER, IMMEDIATELY HOSPITALIZED WITH A SERIOUS INFECTION AND BILATERAL SWELLING OF THE BREAST WALL, SIGNIFICANT BREAST PAIN AND "BOTH IMPLANTS WERE TEXTURED FROM INFORMATION AND BELIEF, WHICH FROM INFORMATION AND BELIEF WERE ALSO RECALLED IN THE LATER RECALL BY THE FDA." THE REPORTED EVENTS OF LUMPS AND BODY ACHES HAVE BEEN DEEMED NOT RELATED TO THE DEVICE. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2396617 | INSPIRA TEXTURE COHESIVE SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | TCLP-280 | 2961172 | 10888628030688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |