SCULPTRA
Report
- Report Number
- 1000118068-2025-00026
- Event Type
- Injury
- Date Received
- December 16, 2025
- Date of Event
- March 18, 2024
- Report Date
- February 27, 2026
- Manufacturer
- Q-MED AB
- Product Code
- LMH
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
COMPANY COMMENT: THE SERIOUS EVENT OF GRANULOMA SKIN WAS CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. SERIOUSNESS CRITERIA INCLUDES THE NEED FOR MEDICAL INTERVENTION AND LONG-STANDING EVENT SUGGESTIVE OF PERMANENT DAMAGE. THE POTENTIAL ROOT CAUSE IS THE TREATMENT PROCEDURE OR A FOREIGN BODY REACTION TO THE PRODUCT IN THE LOCAL TISSUE. POTENTIAL CONTRIBUTORY FACTOR INCLUDES OFF LABEL USE. THE SCULPTRA WAS USED OFF LABEL IN BREAST. THE CASE MEETS THE CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. EVALUATION TEXT: ROUTINE INVESTIGATIONS HAVE BEEN PERFORMED AND HAVE PROVIDED SUFFICIENT INFORMATION TO ASSESS THE POTENTIAL ROOT CAUSE, INDICATING A POSSIBLE ASSOCIATION WITH THE TREATMENT PROCEDURE OR THE PRODUCT. THE REPORTED LOT NUMBERS 1J7493 AND 3J3573 WERE VALID AND VERIFIED THE REPORTED PRODUCT. FOR LOT 1J7493, NINE MEDICAL COMPLAINTS HAVE BEEN REPORTED FOR THE LOT NUMBER, INCLUDING THIS CASE. HOWEVER, ONLY THREE OF THESE CASES (INCLUDING THE CASE OF CONCERN) INVOLVED A NODULE OR GRANULOMA SKIN. FOR LOT 3J3573, SIX MEDICAL COMPLAINTS HAVE BEEN REPORTED FOR THE LOT NUMBER, INCLUDING THIS CASE. HOWEVER, ONLY THREE OF THESE CASES (INCLUDING THE CASE OF CONCERN) INVOLVED A NODULE. THE REPORTED LOT NUMBER 3J111 WAS NOT A VALID LOT NUMBER FOR A GALDERMA PRODUCT. FOLLOW-UP ATTEMPTS TO VERIFY THIS LOT NUMBER HAVE BEEN MADE. A REPEAT BATCH RECORD REVIEW HAS BEEN CONDUCTED FOR EACH VALID LOT NUMBER. SANOFI HAS CONFIRMED THAT NO QUALITY ISSUES HAVE BEEN IDENTIFIED IN THE OVERALL MANUFACTURING PROCESS OF THE SPECIFIED BATCHES. THE BATCHES CONFORMED TO CGMP AND SPECIFICATION REQUIREMENTS. THE INFORMATION AVAILABLE IN THIS CASE DOES NOT INDICATE A NON-CONFORMING PRODUCT OR MALFUNCTION. THE INVESTIGATIONS PERFORMED ARE THEREFORE CONSIDERED ADEQUATE, AND NO ADDITIONAL INVESTIGATIONS WILL BE CONDUCTED. CAPA COMMENT: NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY BASED ON THE OUTCOME OF THE PERFORMED INVESTIGATIONS.
COMPANY COMMENT: THE SERIOUS EVENT OF NODULE AT IMPLANT SITE WAS CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. SERIOUSNESS CRITERIA INCLUDES THE NEED FOR MEDICAL INTERVENTION AND LONG-STANDING EVENT SUGGESTIVE OF PERMANENT DAMAGE. THE POTENTIAL ROOT CAUSE IS THE TREATMENT PROCEDURE. POTENTIAL CONTRIBUTORY FACTOR INCLUDES OFF LABEL USE. THE SCULPTRA WAS USED OFF LABEL IN BREAST. THE CASE MEETS THE CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. EVALUATION TEXT: ROUTINE INVESTIGATIONS HAVE BEEN PERFORMED AND HAVE PROVIDED SUFFICIENT INFORMATION TO ASSESS THE POTENTIAL ROOT CAUSE, INDICATING A POSSIBLE ASSOCIATION WITH THE TREATMENT PROCEDURE. THE REPORTED LOT NUMBERS 1J7493 AND 3J3573 WERE VALID AND VERIFIED THE REPORTED PRODUCT. FOR LOT 1J7493, NINE MEDICAL COMPLAINTS HAVE BEEN REPORTED FOR THE LOT NUMBER, INCLUDING THIS CASE. HOWEVER, ONLY THREE OF THESE CASES (INCLUDING THE CASE OF CONCERN) INVOLVED A NODULE. FOR LOT 3J3573, SIX MEDICAL COMPLAINTS HAVE BEEN REPORTED FOR THE LOT NUMBER, INCLUDING THIS CASE. HOWEVER, ONLY THREE OF THESE CASES (INCLUDING THE CASE OF CONCERN) INVOLVED A NODULE. THE REPORTED LOT NUMBER 3J111 WAS NOT A VALID LOT NUMBER FOR A GALDERMA PRODUCT. FOLLOW-UP ATTEMPTS TO VERIFY THIS LOT NUMBER HAVE BEEN MADE BUT WERE UNSUCCESSFUL. A REPEAT BATCH RECORD REVIEW HAS BEEN CONDUCTED FOR EACH VALID LOT NUMBER. SANOFI HAS CONFIRMED THAT NO QUALITY ISSUES HAVE BEEN IDENTIFIED IN THE OVERALL MANUFACTURING PROCESS OF THE SPECIFIED BATCHES. THE BATCHES CONFORMED TO CGMP AND SPECIFICATION REQUIREMENTS. THE INFORMATION AVAILABLE IN THIS CASE DOES NOT INDICATE A NON-CONFORMING PRODUCT OR MALFUNCTION. THE INVESTIGATIONS PERFORMED ARE THEREFORE CONSIDERED ADEQUATE, AND NO ADDITIONAL INVESTIGATIONS WILL BE CONDUCTED. CAPA COMMENT: NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY BASED ON THE OUTCOME OF THE PERFORMED INVESTIGATIONS.
COMPANY COMMENT: THE SERIOUS EVENT OF NODULE AT IMPLANT SITE WAS CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. SERIOUSNESS CRITERIA INCLUDES THE NEED FOR MEDICAL INTERVENTION AND LONG-STANDING EVENT SUGGESTIVE OF PERMANENT DAMAGE. THE POTENTIAL ROOT CAUSE IS THE TREATMENT PROCEDURE. POTENTIAL CONTRIBUTORY FACTOR INCLUDES OFF LABEL USE. THE SCULPTRA WAS USED OFF LABEL IN BREAST. THE CASE MEETS THE CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. EVALUATION TEXT: ROUTINE INVESTIGATIONS HAVE BEEN PERFORMED AND PROVIDE SUFFICIENT INFORMATION TO ASSESS THE POTENTIAL ROOT CAUSE AND INDICATE A POSSIBLE ASSOCIATION TO THE TREATMENT PROCEDURE. THE REPORTED LOT NUMBERS 1J7493 AND 3J3573 ARE VALID AND VERIFY THE REPORTED PRODUCT. FOR LOT 1J7493, NINE MEDICAL COMPLAINTS HAVE BEEN REPORTED TO THE LOT NUMBER, INCLUDING THIS CASE. HOWEVER, ONLY THREE OF THESE CASES (INCLUDING THE CASE OF CONCERN) INVOLVED A NODULE. FOR LOT 3J3573, SEX MEDICAL COMPLAINTS HAVE BEEN REPORTED TO THE LOT NUMBER, INCLUDING THIS CASE. HOWEVER, ONLY THREE OF THESE CASES (INCLUDING THE CASE OF CONCERN) INVOLVED A NODULE. THE REPORTED LOT NUMBER 3J111 WAS NOT A VALID LOT NUMBER FOR A GALDERMA PRODUCT. A FOLLOW-UP WILL BE PERFORMED TO VERIFY THIS LOT NUMBER. TO RULE OUT THE POSSIBILITY OF A NON-CONFORMING PRODUCT, BATCH RECORD REVIEWS WILL BE REQUESTED. CAPA COMMENT: NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY BASED ON THE OUTCOME OF THE CURRENTLY PERFORMED INVESTIGATIONS.
CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON 16-SEP-2025 BY A PHYSICIAN VIA SALES REPRESENTATIVE CONCERNING A 60-YEAR-OLD FEMALE PATIENT. THE PATIENT UNDERWENT BREAST SURGERY 2 TO 3 YEARS BEFORE AND HAD MULTIPLE COSMETIC BREAST PROCEDURES, INCLUDING WISE-PATTERN MASTOPEXY. IN (B)(6) 2017, THE PATIENT UNDERWENT AN ANTERIOR CAPSULECTOMY AND EXCHANGE OF IMPLANTS. REVISION BREAST SURGERY AND MASTOPEXY, BILATERAL IMPLANT EXCHANGE ON (B)(6) 2022 AND (B)(6) 2022, REVISION VERTICAL MASTOPEXY ON (B)(6) 2022. POSTOPERATIVELY, SHE DEVELOPED CONTOUR DEFECT IN THE INFERIOR POLE/BREAST DISFIGURATION, AND THE PATIENT DID NOT WANT ANOTHER REVISION. AFTER DISCUSSION, THEY AGREED FOR OFF LABEL USE OF SCULPTRA. THE PATIENT HAD NO KNOWN ALLERGIES AND WAS NOT TAKING ANY CONCOMITANT MEDICATIONS. NO CONCOMITANT FILLER OR TOXIN TREATMENT WAS PERFORMED TO THE AFFECTED AREA. THE PATIENT HAD PREVIOUSLY RECEIVED TREATMENT WITH 28 UNITS OF BOTOX [BOTULINUM TOXIN TYPE A] TO FOREHEAD, GLABELLA AND TAIL OF BROW WITH 2 ML DILUTION AND 1 ML OF VOLUMA ON RIGHT AND LEFT CHEEK ON (B)(6) 2020. ON (B)(6) 2020, 0.55 ML OF VOLBELLA TO PERIORAL, UPPER AND LOWER LIP. ON (B)(6) 2021, 33 UNITS OF BOTOX TO FOREHEAD, GLABELLA, CROW'S FEET WITH 2 ML DILUTION. ON (B)(6) 2021, 38 UNITS OF BOTOX TO FOREHEAD, GLABELLA, CROW'S FEET WITH 2 ML DILUTION. ON (B)(6) 2021, 38 UNITS OF BOTOX TO FOREHEAD, GLABELLA, CROW'S FEET WITH 2 ML DILUTION AND 1 ML OF VOLUMA ON RIGHT AND LEFT CHEEK. ON (B)(6) 2022 AND (B)(6) 2022, 51 UNITS OF BOTOX ON GLABELLA, CROW'S FEET, UPPER LIP AND CHIN WITH 2 ML DILUTION. ON (B)(6) 2022, 51 UNITS OF BOTOX ON GLABELLA, CROW'S FEET, UPPER LIP AND CHIN WITH 2 ML DILUTION AND 1 ML OF VOLUMA ON RIGHT AND LEFT CHEEK. ON (B)(6) 2022 AND 09-MAR-2023, 51 UNITS OF BOTOX TO GLABELLA, CROW'S FEET, UPPER LIP AND CHIN WITH 2 ML DILUTION. ON (B)(6) 2023, 51 UNITS OF BOTOX TO GLABELLA, CROW'S FEET, UPPER LIP AND CHIN WITH 2 ML DILUTION AND 1ML OF RHA REDENSITY ON UPPER AND LOWER LIP ON. ON (B)(6) 2023, THE HCP APPLIED TOPICAL CRYOANESTHESIA AND NUMBED THE AREA FOR APPROXIMATELY 15 MINUTES. THE SKIN WAS PREPARED WITH BENZALKONIUM CHLORIDE [BENZALKONIUM CHLORIDE]. THE PATIENT RECEIVED TREATMENT WITH 16 ML (2 VIALS) OF SCULPTRA (LOT 1J7493), 8 ML WHICH WAS 1 VIAL TO EACH SIDE OF THE BREASTS USING 25G NEEDLE ON RIGHT BREAST AND 22G NEEDLE ON LEFT BREAST WITH FAN TECHNIQUE FOR POST OPERATION HOLLOWING OR BREAST DISFIGURATION. THE SCULPTRA WAS INJECTED TO BILATERAL BREASTS (OFF LABEL USE OF DEVICE). ON (B)(6) 2023, THE HCP PREPARED THE AREA WITH TOPICAL CRYOANESTHESIA, SKIN WAS PREPARED WITH BENZALKONIUM CHLORIDE. THEN, THE PATIENT RECEIVED TREATMENT WITH 16 ML (2 VIALS) OF SCULPTRA (LOT 3J111), 8 ML WHICH WAS 1 VIAL TO EACH SIDE OF THE BREASTS USING 22G NEEDLE WITH FAN TECHNIQUE FOR POST OPERATION HOLLOWING. ON THE SAME DAY, THE PATIENT ALSO RECEIVED TREATMENT WITH 51 UNITS OF BOTOX TO GLABELLA, CROW'S FEET, UPPER LIP AND CHIN WITH 2 ML DILUTION. ON (B)(6) 2023, THE HCP PREPARED THE AREA WITH TOPICAL CRYOANESTHESIA, AND ALCOHOL [ALCOHOL]. THE PATIENT RECEIVED TREATMENT WITH 16 ML (2 VIALS) OF SCULPTRA (LOT 3J111), 8 ML WHICH WAS 1 VIAL TO EACH SIDE OF THE BREASTS USING 22G NEEDLE WITH FAN TECHNIQUE FOR POST OPERATION HOLLOWING. ON (B)(6) 2024, THE HCP PREPARED THE AREA WITH TOPICAL CRYOANESTHESIA AND BENZALKONIUM CHLORIDE. THE PATIENT RECEIVED TREATMENT WITH 16 ML (2 VIALS) OF SCULPTRA (LOT 3J3573, EXPIRY DATE 30-JUN-2026), 8 ML WHICH WAS 1 VIAL TO EACH SIDE OF THE BREASTS USING 25G NEEDLE WITH FAN TECHNIQUE FOR POST OPERATION HOLLOWING. ON (B)(6) 2024, THE PATIENT EXPERIENCED MODERATE TO SEVERE NODULES/GRANULOMAS/LUMPS (GRANULOMA SKIN) ON THE LEFT AND RIGHT BREAST. THE PATIENT HAD MULTIPLE SMALL SCULPTRA NODULES ON EXAMINATION WITH MORE NODULE ON RIGHT THAN LEFT. ON THE SAME DAY, THE PATIENT RECEIVED TREATMENT WITH 51 UNITS OF BOTOX TO GLABELLA, CROW'S FEET, UPPER LIP AND CHIN WITH 2 ML DILUTION. ON (B)(6) 2024, THE PATIENT RECEIVED TREATMENT WITH BOTOX TO LIP. THE HCP TREATED THE PATIENT WITH 5 ML OF 5MG/ML OF KENALOG [TRIAMCINOLONE ACETONIDE] DILUTED WITH 2.5 ML OF 2 PERCENT LIDOCAINE [LIDOCAINE], ADMINISTERED 2.5 ML PER BREAST. MASSAGE WAS PERFORMED AFTERWARD. THE PATIENT DID NOT FEEL THAT THE TREATMENT MADE ANY DIFFERENCE, THEREFORE DECLINED OFFERS OF REPEAT TREATMENT WITH KENALOG, OR A STRONGER PERCENTAGE OF KENALOG. ADDITIONALLY, THE PATIENT PERFORMED MASSAGE, INCLUDING AT HOME AND WITH A LYMPHATIC MASSEUSE. ON (B)(6) 2025, THE PATIENT AND THE REPORTING HCP DISCUSSED TREATMENT OPTIONS VIA A PHONE CALL, INCLUDING ADDITIONAL STEROID INJECTIONS, POTENTIALLY ADDITION OF 5FU, ORAL ANTIBIOTICS (DOXYCYCLINE OR MINOCYCLINE), ORAL STEROIDS, WEEKLY METHOTREXATE 10-15 MG, TARGETED INJECTIONS INTO SPECIFIC LARGE NODULES RATHER THAN MORE DIFFUSE ANTIBIOTIC THERAPY AND REVISION SURGERY. BUT PATIENT WAS NOT WILLING TO TRY THESE TREATMENTS, AND SHE WAS SEEKING ADDITIONAL ADVICE AND ALTERNATIVE OPTIONS. AT THE TIME OF THE REPORT ON 09-JAN-2026, THE NODULES WERE PERSISTENT PALPABLE AND VISIBLE, WHICH WERE DISTRESSING TO THE PATIENT. THE REPORTING PHYSICIAN ASSESSED THE CAUSALITY TO THE TREATMENT AS POSSIBLE. OUTCOME AT THE TIME OF THE REPORT: NODULES/GRANULOMAS/LUMPS WAS NOT RECOVERED/NOT RESOLVED/ONGOING. SCULPTRA WAS INJECTED TO BILATERAL BREASTS WAS RECOVERED/RESOLVED. TRACKING LIST: V.0 INITIAL V.1 FU RECEIVED ON 17-NOV-2025 FROM SAME REPORTER. CASE UPGRADED TO SERIOUS. EVENT (OFF LABEL USE OF DEVICE) ADDED. PATIENT DEMOGRAPHICS, MEDICAL HISTORY, SUSPECT DEVICE IMPLANT DATES, LOCATION, VOLUME, NEEDLE TYPE, LOT NUMBER, EXPIRY DATE, EVENT ONSET DATE, SEVERITY LOCATION, OUTCOME, REPORTER CAUSALITY AND CORRECTIVE TREATMENTS DETAILS WERE UPDATED. V.2 BATCH RECORD REVIEW INVESTIGATION RESULTS WERE RECEIVED ON 28-DEC-2025. FU2 RECEIVED ON 09-JAN-2026 FROM THE SAME REPORTER. INFORMATION REGARDING CONCOMITANT FILLER OR TOXIN TREATMENTS, CORRECTIVE TREATMENT DETAILS AND OUTCOME WAS UPDATED. V.3 FU RECEIVED ON 28-JAN-2026 FROM ANOTHER HCP REPORTER. THE (B)(4) WAS CONSIDERED AS A DUPLICATE OF (B)(4). ALL INFORMATION FROM THE (B)(4) WAS TRANSFERRED TO (B)(4). EVENT VERBATIM AND EVENT CODING UPDATED (IMPLANT SITE NODULE TO GRANULOMA SKIN), REPORTER ADDED, PATIENT MEDICAL HISTORY UPDATED, PREVIOUS TREATMENT (BOTOX, VOLUMA, VOLBELLA) ADDED, CONCOMITANT MEDICATION (BENZALKONIUM CHLORIDE, ALCOHOL) ADDED, CORRECTIVE TREATMENT (LIDOCAINE) ADDED, NARRATIVE UPDATED.
CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON (B)(6) 2025 BY A PHYSICIAN VIA SALES REPRESENTATIVE CONCERNING A 60-YEAR-OLD FEMALE PATIENT. THE PATIENT UNDERWENT REVISION BREAST SURGERY AND MASTOPEXY, IMPLANT EXCHANGE ON (B)(6) 2022. POSTOPERATIVELY, SHE DEVELOPED CONTOUR DEFECT IN THE INFERIOR POLE, AND THE PATIENT DID NOT WANT ANOTHER REVISION. AFTER DISCUSSION, THEY AGREED FOR OFF LABEL USE OF SCULPTRA. THE PATIENT HAD NO KNOWN ALLERGIES AND WAS NOT TAKING ANY CONCOMITANT MEDICATIONS. NO CONCOMITANT FILLER OR TOXIN TREATMENT WAS PERFORMED TO THE AFFECTED AREA. ON (B)(6) 2023, THE PATIENT RECEIVED TREATMENT WITH 16 ML (2 VIALS) OF SCULPTRA (LOT 1J7493), 8 ML WHICH WAS 1 VIAL TO EACH SIDE OF THE BREASTS USING 25G NEEDLE WITH FAN TECHNIQUE FOR POST OPERATION HOLLOWING. THE SCULPTRA WAS INJECTED TO BILATERAL BREASTS (OFF LABEL USE OF DEVICE). ON (B)(6) 2023, THE PATIENT RECEIVED TREATMENT WITH 16 ML (2 VIALS) OF SCULPTRA (LOT 3J111), 8 ML WHICH WAS 1 VIAL TO EACH SIDE OF THE BREASTS USING 25G NEEDLE WITH FAN TECHNIQUE FOR POST OPERATION HOLLOWING. ON (B)(6) 2024, THE PATIENT RECEIVED TREATMENT WITH 16 ML (2 VIALS) OF SCULPTRA (LOT 3J3573, EXPIRY DATE 30-JUN-2026), 8 ML WHICH WAS 1 VIAL TO EACH SIDE OF THE BREASTS USING 25G NEEDLE WITH FAN TECHNIQUE FOR POST OPERATION HOLLOWING. ON (B)(6) 2024, THE PATIENT EXPERIENCED MODERATE TO SEVERE NODULE (IMPLANT SITE NODULE) ON THE LEFT AND RIGHT BREAST. IN (B)(6) 2024, THE PATIENT RECEIVED TREATMENT WITH 5 ML OF 5 PERCENT KENALOG [TRIAMCINOLONE ACETONIDE], ADMINISTERED 2.5 ML PER BREAST. THE PATIENT DID NOT FEEL THAT THE TREATMENT MADE ANY DIFFERENCE, THEREFORE DECLINED OFFERS OF REPEAT TREATMENT WITH KENALOG, OR A STRONGER PERCENTAGE OF KENALOG. ADDITIONALLY, THE PATIENT PERFORMED MASSAGE, INCLUDING AT HOME AND WITH A LYMPHATIC MASSEUSE. THE PATIENT AND THE REPORTING HCP DISCUSSED TREATMENT OPTIONS, INCLUDING ADDITIONAL STEROID INJECTIONS (POTENTIALLY ADDITION OF 5FU), ORAL ANTIBIOTICS (DOXYCYCLINE OR MINOCYCLINE), ORAL STEROIDS, WEEKLY METHOTREXATE, AND REVISION SURGERY. BUT PATIENT WAS NOT WILLING TO TRY THESE TREATMENTS, AND SHE WAS SEEKING ADDITIONAL ADVICE AND ALTERNATIVE OPTIONS. AT THE TIME OF THE REPORT ON (B)(6) 2026, THE NODULES WERE PERSISTENT PALPABLE AND VISIBLE, WHICH WERE DISTRESSING TO THE PATIENT. THE REPORTING PHYSICIAN ASSESSED THE CAUSALITY TO THE TREATMENT AS POSSIBLE. OUTCOME AT THE TIME OF THE REPORT: NODULE WAS NOT RECOVERED/NOT RESOLVED/ONGOING. SCULPTRA WAS INJECTED TO BILATERAL BREASTS WAS RECOVERED/RESOLVED. TRACKING LIST: V.0 INITIAL V.1 FU RECEIVED ON 17-NOV2025 FROM SAME REPORTER. CASE UPGRADED TO SERIOUS. EVENT (OFF LABEL USE OF DEVICE) ADDED. PATIENT DEMOGRAPHICS, MEDICAL HISTORY, SUSPECT DEVICE IMPLANT DATES, LOCATION, VOLUME, NEEDLE TYPE, LOT NUMBER, EXPIRY DATE, EVENT ONSET DATE, SEVERITY LOCATION, OUTCOME, REPORTER CAUSALITY AND CORRECTIVE TREATMENTS DETAILS WERE UPDATED. V.2 BATCH RECORD REVIEW INVESTIGATION RESULTS WERE RECEIVED ON 28-DEC-2025. FU2 RECEIVED ON 09-JAN-2026 FROM THE SAME REPORTER. INFORMATION REGARDING CONCOMITANT FILLER OR TOXIN TREATMENTS, CORRECTIVE TREATMENT DETAILS AND OUTCOME WAS UPDATED.
CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON 16-SEP-2025 BY A PHYSICIAN VIA SALES REPRESENTATIVE CONCERNING A 60-YEAR-OLD FEMALE PATIENT. THE PATIENT UNDERWENT REVISION BREAST SURGERY AND MASTOPEXY, IMPLANT EXCHANGE ON (B)(6) 2022. POSTOPERATIVELY, SHE DEVELOPED CONTOUR DEFECT IN THE INFERIOR POLE, AND THE PATIENT DID NOT WANT ANOTHER REVISION. AFTER DISCUSSION, THEY AGREED FOR OFF LABEL USE OF SCULPTRA. THE PATIENT HAD NO KNOWN ALLERGIES AND WAS NOT TAKING ANY CONCOMITANT MEDICATIONS. NO INFORMATION ABOUT PREVIOUS FILLER TREATMENTS HAS BEEN PROVIDED. ON (B)(6) 2023, THE PATIENT RECEIVED TREATMENT WITH 16 ML (2 VIALS) OF SCULPTRA (LOT 1J7493), 8 ML WHICH WAS 1 VIAL TO EACH SIDE OF THE BREASTS USING 25G NEEDLE WITH FAN TECHNIQUE FOR POST OPERATION HOLLOWING. THE SCULPTRA WAS INJECTED TO BILATERAL BREASTS (OFF LABEL USE OF DEVICE). ON (B)(6) 2023, THE PATIENT RECEIVED TREATMENT WITH 16 ML (2 VIALS) OF SCULPTRA (LOT 3J111), 8 ML WHICH WAS 1 VIAL TO EACH SIDE OF THE BREASTS USING 25G NEEDLE WITH FAN TECHNIQUE FOR POST OPERATION HOLLOWING. ON (B)(6) 2024, THE PATIENT RECEIVED TREATMENT WITH 16 ML (2 VIALS) OF SCULPTRA (LOT 3J3573, EXPIRY DATE 30-JUN-2026), 8 ML WHICH WAS 1 VIAL TO EACH SIDE OF THE BREASTS USING 25G NEEDLE WITH FAN TECHNIQUE FOR POST OPERATION HOLLOWING. ON (B)(6) 2024, THE PATIENT EXPERIENCED MODERATE TO SEVERE NODULE (IMPLANT SITE NODULE) ON THE LEFT AND RIGHT BREAST. IN (B)(6) 2024, THE PATIENT RECEIVED TREATMENT WITH 5 ML OF KENALOG [TRIAMCINOLONE ACETONIDE]. FOLLOWING THE TREATMENT, THERE WAS NO CHANGE. AT THE TIME OF THE REPORT, ON (B)(6) 2025, THE NODULE WAS ONGOING. THE REPORTING PHYSICIAN ASSESSED THE CAUSALITY TO THE TREATMENT AS POSSIBLE. OUTCOME AT THE TIME OF THE REPORT: NODULE WAS NOT RECOVERED/NOT RESOLVED/ONGOING. SCULPTRA WAS INJECTED TO BILATERAL BREASTS WAS RECOVERED/RESOLVED. TRACKING LIST: V.0 INITIAL V.1 FU RECEIVED ON 17-NOV2025 FROM SAME REPORTER. CASE UPGRADED TO SERIOUS. EVENT (OFF LABEL USE OF DEVICE) ADDED. PATIENT DEMOGRAPHICS, MEDICAL HISTORY, SUSPECT DEVICE IMPLANT DATES, LOCATION, VOLUME, NEEDLE TYPE, LOT NUMBER, EXPIRY DATE, EVENT ONSET DATE, SEVERITY LOCATION, OUTCOME, REPORTER CAUSALITY AND CORRECTIVE TREATMENTS DETAILS WERE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 464099 | SCULPTRA | IMPLANT, DERMAL, FOR AESTHETIC USE | LMH | Q-MED AB | 1J7493, 3J111, 3J3573 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Female | Disability| R |