STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2023-02229
- Event Type
- Injury
- Date Received
- February 14, 2023
- Date of Event
- January 1, 2015
- Report Date
- June 7, 2024
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- UDI-DI
- 05060191601382
- PMA / PMN Number
- P040046
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE EVENT OF INFECTION IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN/WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE REASON FOR REOPERATION: "SEVERE BACTERIAL INFESTATION". PHOTO EVALUATION: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: PAIN: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. VARIED INJURIES-NDR: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. OTHER MEDICAL-NDR: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. PAIN-NDR: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. INFECTION (UNKNOWN ONSET): UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE SKIN RASH/DERMATITIS-NDR: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. IT IS NOT POSSIBLE TO DETERMINE THE LOT NUMBER OR CATALOG THROUGH THE PHOTOS PROVIDED. REFER TO (B)(4): COVID-19 QUALITY PLAN - COMPLAINT HANDLING.
PHOTO ANALYSIS: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: RUPTURE: OBSERVED BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. PAIN: UNABLE TO OBSERVE AS IT IS A MEDICAL EVENT THAT IS NOT RELATED TO THE DEVICE. SILICONE MIGRATION: UNABLE TO OBSERVE AS IT IS A MEDICAL EVENT THAT IS NOT RELATED TO THE DEVICE. INFECTION (UNKNOWN ONSET: UNABLE TO OBSERVE AS IT IS A MEDICAL EVENT THAT IS NOT RELATED TO THE DEVICE. ADDITIONAL OBSERVATIONS: RED PARTICLES ON THE SURFACE OF THE SHELL. IT IS NOT POSSIBLE TO DETERMINE THE LOT NUMBER OR CATALOG THROUGH THE PHOTOS PROVIDED. FURTHER INVESTIGATION: WITH THE INFORMATION COLLECTED DURING THE INVESTIGATION, THERE IS ENOUGH EVIDENCE TO SUPPORT THAT DEVICE SERIAL NUMBER (B)(6) WAS MANUFACTURED UNDER CONTROLLED CONDITIONS IN ACCORDANCE WITH ABBVIE¿S PROCEDURES AND WERE NO DEFECTS/PROBLEMS/ISSUES FOUND IN THE DOCUMENTS RELATED TO THE REPORTED EVENT. 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. THE STERILIZATION RUN 30012812 IS NOT RELATED TO ANY ADDITIONAL COMPLAINT INFECTION RECORD REPORTED AS OF TODAY. DURING THE TREND REVIEW OF ALL GEL INFECTION COMPLAINTS FOR THE PERIOD OF (B)(6)2021 THROUGH (B)(6)2023, 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, AND NO ER/ NCR(S) OR TEMPORARY CHANGES WERE IDENTIFIED DURING THE INVESTIGATION ASSOCIATED TO THIS LOT AND THE COMPLAINT, NO CORRECTIVE ACTION IS DEEMED NECESSARY AT THIS TIME.
CLARIFICATION TO D.9. RETURNED TO MFG ON: THE DEVICE HAS NOT BEEN RETURNED. PHOTO EVALUATION: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: VARIED INJURIES-NDR: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. OTHER MEDICAL-NDR: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. PAIN-NDR: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. INFECTION (UNKNOWN ONSET): UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. SKIN RASH/DERMATITIS-NDR: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. RUPTURE: OBSERVED BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. SILICONE MIGRATION: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. PAIN: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. MALAISE-NDR: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. NO ADDITIONAL OBSERVATIONS WERE CARRIED OUT. NO FURTHER ACTIONS ARE REQUIRED AS NO MANUFACTURING ISSUES ARE OBSERVED. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: H6.
THE EVENT OF SILICONE MIGRATION IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: A4, B5, D4, H4, H6.
ADDITIONAL, CORRECTED AND/OR CHANGED DATA: B.5.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: H.6
PATIENT REPORTED THE EVENTS OF ¿JOINT AND MUSCLE ACHES¿ - NDR, ¿SLIGHT FEVER FROM TIME TO TIME¿-NDR, ¿RED SPOT UNDER THE ARMPIT (SIDE UNKNOWN)¿-NDR, ¿MUSCLE TWITCHING ON ONE SIDE (FULL BODY AND FACE)-NDR¿, ¿HAIR LOSS¿-NDR, ¿SORE THROAT / DIFFICULTIES SWALLOWING¿-NDR, ¿RUNNY NOSE¿-NDR, ¿RINGING IN THE EARS¿-NDR, ¿CHEST PAIN¿, ¿IRRITABLE BOWEL SYNDROME¿-NDR, ¿EXTREMELY DRY EYES¿-NDR, ¿DAILY WEAK EYESIGHT¿-NDR, ¿ADRENAL FATIGUE¿-NDR, AND "MCAS. SUBSEQUENTLY, PATIENT REPRESENTATIVE REPORTED, SYMPTOMS OF BREAST IMPLANT ILLNESS, EYE PAIN-NDR, DRY EYES-NDR, MUSCLE TWITCHING-NDR, HAIR LOSS-NDR, SKIN RASHES-NDR, NECK AND JOINT PAIN - NDR, PRESSURE SENSATION PAIN-NDR, GASTROINTESTINAL COMPLAINTS AND HIGH CONCENTRATION OF HEAVY METALS AND SILICONE IN BLOOD-NDR, INTESTINAL DISCOMFORT-NDR, FEVER-NDR, INTOLERANCE-NDR AND "THERE WAS A SEVERE BACTERIAL INFESTATION OF THE LEFT IMPLANT CAPSULE." NDR EVENTS ARE NOT DEVICE RELATED. THE DEVICE HAS BEEN EXPLANTED. THIS RELATES TO THE RIGHT SIDE.
PATIENT REPORTED THE EVENTS OF ¿JOINT AND MUSCLE ACHES¿ - NDR, ¿SLIGHT FEVER FROM TIME TO TIME¿-NDR, ¿RED SPOT UNDER THE ARMPIT (SIDE UNKNOWN)¿-NDR, ¿MUSCLE TWITCHING ON ONE SIDE (FULL BODY AND FACE)-NDR¿, ¿HAIR LOSS¿-NDR, ¿SORE THROAT / DIFFICULTIES SWALLOWING¿-NDR, ¿RUNNY NOSE¿-NDR, ¿RINGING IN THE EARS¿-NDR, ¿CHEST PAIN¿, ¿IRRITABLE BOWEL SYNDROME¿-NDR, ¿EXTREMELY DRY EYES¿-NDR, ¿DAILY WEAK EYESIGHT¿-NDR, ¿ADRENAL FATIGUE¿-NDR, AND "MCAS. SUBSEQUENTLY, PATIENT REPRESENTATIVE REPORTED, SYMPTOMS OF BREAST IMPLANT ILLNESS, EYE PAIN-NDR, DRY EYES-NDR, MUSCLE TWITCHING-NDR, HAIR LOSS-NDR, SKIN RASHES-NDR, NECK AND JOINT PAIN - NDR, PRESSURE SENSATION PAIN-NDR, GASTROINTESTINAL COMPLAINTS AND HIGH CONCENTRATION OF HEAVY METALS AND SILICONE IN BLOOD-NDR, INTESTINAL DISCOMFORT-NDR, FEVER-NDR, INTOLERANCE-NDR AND "THERE WAS A SEVERE BACTERIAL INFESTATION OF THE LEFT IMPLANT CAPSULE." NDR EVENTS ARE NOT DEVICE RELATED. PATIENT ADDITIONALLY REPORTED RUPTURE AND SILICONE IN BLOOD. THE DEVICE HAS BEEN EXPLANTED. THIS RELATES TO THE RIGHT SIDE.
PATIENT REPORTED THE EVENTS OF ¿JOINT AND MUSCLE ACHES¿ - NDR, ¿SLIGHT FEVER FROM TIME TO TIME¿-NDR, ¿RED SPOT UNDER THE ARMPIT (SIDE UNKNOWN)¿-NDR, ¿MUSCLE TWITCHING ON ONE SIDE (FULL BODY AND FACE)-NDR¿, ¿HAIR LOSS¿-NDR, ¿SORE THROAT / DIFFICULTIES SWALLOWING¿-NDR, ¿RUNNY NOSE¿-NDR, ¿RINGING IN THE EARS¿-NDR, ¿CHEST PAIN¿, ¿IRRITABLE BOWEL SYNDROME¿-NDR, ¿EXTREMELY DRY EYES¿-NDR, ¿DAILY WEAK EYESIGHT¿-NDR, ¿ADRENAL FATIGUE¿-NDR, AND "MCAS. SUBSEQUENTLY, PATIENT REPRESENTATIVE REPORTED, SYMPTOMS OF BREAST IMPLANT ILLNESS, EYE PAIN-NDR, DRY EYES-NDR, MUSCLE TWITCHING-NDR, HAIR LOSS-NDR, SKIN RASHES-NDR, NECK AND JOINT PAIN - NDR, PRESSURE SENSATION PAIN-NDR, GASTROINTESTINAL COMPLAINTS AND HIGH CONCENTRATION OF HEAVY METALS AND SILICONE IN BLOOD-NDR, INTESTINAL DISCOMFORT-NDR, FEVER-NDR, INTOLERANCE-NDR AND "THERE WAS A SEVERE BACTERIAL INFESTATION OF THE LEFT IMPLANT CAPSULE." NDR EVENTS ARE NOT DEVICE RELATED. THE DEVICE HAS BEEN EXPLANTED. THIS RELATES TO THE RIGHT SIDE.
PATIENT ADDITIONALLY REPORTED RUPTURE AND SILICONE IN BLOOD.
PATIENT REPORTED JOINT, NECK AND MUSCLE PAIN, FEVER, RED SPOT UNDER THE ARMPIT, MUSCLE TWITCHING, HAIR LOSS, SORE THROAT/DIFFICULTY SWALLOWING, RUNNY NOSE, RINGING IN THE EARS, CHEST PAIN, GASTROINTESTINAL COMPLAINTS, EXTREMELY DRY EYES, EYE PAIN, DAILY WEAK EYESIGHT, ADRENAL FATIGUE, MCAS, FATIGUE, RUPTURE OF THE IMPLANT (DISCOVERED ON EXPLANATION), SILICONE AND HEAVY METALS IN THE BLOOD. IN ADDITION, THE PATIENT'S REPRESENTATIVE REPORTED "BREAST IMPLANT ILLNESS (BII) SYMPTOMS" PREVIOUSLY REPORTED BY THE PATIENT AS WELL AS SKIN RASHES AND PAIN IN BOTH BREASTS. ADDITIONALLY, ANXIETY AND "SEVERE DEPRESSIVE STRESS DISORDERS¿ AND ¿DISTURBED SELF-IMAGE OF HERSELF AS A WOMAN AND SIGNIFICANTLY IMPAIRED SELF-ESTEEM¿ WERE REPORTED VIA LEGAL LETTER. THE DEVICE HAS BEEN EXPLANTED WITH EN BLOC CAPSULECTOMY. THIS RELATES TO THE RIGHT SIDE.
PATIENT REPORTED RIGHT SIDE THE EVENTS OF ¿JOINT AND MUSCLE ACHES¿ - NDR, ¿SLIGHT FEVER FROM TIME TO TIME¿-NDR, ¿RED SPOT UNDER THE ARMPIT (SIDE UNKNOWN)¿-NDR, ¿MUSCLE TWITCHING ON ONE SIDE (FULL BODY AND FACE)-NDR¿, ¿HAIR LOSS¿-NDR, ¿SORE THROAT / DIFFICULTIES SWALLOWING¿-NDR, ¿RUNNY NOSE¿-NDR, ¿RINGING IN THE EARS¿-NDR, ¿CHEST PAIN¿, ¿IRRITABLE BOWEL SYNDROME¿-NDR, ¿EXTREMELY DRY EYES¿-NDR, ¿DAILY WEAK EYESIGHT¿-NDR, ¿ADRENAL FATIGUE¿-NDR, AND "MCAS. SUBSEQUENTLY, PATIENT REPRESENTATIVE REPORTED, SYMPTOMS OF BREAST IMPLANT ILLNESS, EYE PAIN-NDR, DRY EYES-NDR, MUSCLE TWITCHING-NDR, HAIR LOSS-NDR, SKIN RASHES-NDR, NECK AND JOINT PAIN - NDR, PRESSURE SENSATION PAIN-NDR, GASTROINTESTINAL COMPLAINTS AND HIGH CONCENTRATION OF HEAVY METALS AND SILICONE IN BLOOD-NDR, INTESTINAL DISCOMFORT-NDR, FEVER-NDR, INTOLERANCE-NDR AND "THERE WAS A SEVERE BACTERIAL INFESTATION OF THE LEFT IMPLANT CAPSULE." NDR EVENTS ARE NOT DEVICE RELATED. THE DEVICE HAS BEEN EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 648659 | STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 2491605 | 05060191601382 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Female | Required Intervention |