UNK MAMMARY IMPLANT
Report
- Report Number
- 9617229-2022-11524
- Event Type
- Injury
- Date Received
- July 14, 2022
- Date of Event
- January 1, 2015
- Report Date
- September 1, 2022
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FWM
- PMA / PMN Number
- P990074
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
"A SOUTH AFRICAN BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA: CLINICAL PRESENTATION AND SIX-YEAR FOLLOW-UP". ALEXANDRA GRUBNIK, YASTIRA RAMDAS, BAREND VAN DER BERGH, SIMON NAYLER, CAROL-ANN BENN AND BERNARDO L. RAPOPORT. HINDAWI, CASE REPORTS IN ONCOLOGICAL MEDICINE, VOLUME 2022, HTTPS://DOI.ORG/10.1155/2022/4162832 31MAY22. (B)(4). THE EVENTS OF LYMPHOMA-ALCL, SEROMA-LATE, LUMP/NODULE, LYMPHADENOPATHY 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: LYMPHOMA-ALCL, SEROMA-LATE, LUMP/NODULE, LYMPHADENOPATHY.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B.3.
HEALTHCARE PROFESSIONAL REPORTED VIA LITERATURE ARTICLE "A SOUTH AFRICAN BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA: CLINICAL PRESENTATION AND SIX-YEAR FOLLOW-UP": PATIENT PRESENTED WITH INITIAL SWELLING OF THE LEFT BREAST. MAMMOGRAPHY, ULTRASOUND, AND MRI REVEALED A PERIPROSTHETIC FLUID COLLECTION AND MASS-LIKE ENHANCEMENT ON THE LEFT BREAST SHOWING SUSTAINED PERIPHERAL ENHANCEMENT. BIOMARKERS CD30+ AND ALK- WERE RECEIVED, INDICATIVE OF BIA-ALCL. THE PATIENT UNDERWENT ¿EN BLOC¿ CAPSULECTOMY. SURGERY AND RECOVERY WERE UNEVENTFUL. THE CAPSULECTOMY REVEALED FIBROUS CONNECTIVE TISSUE WITH THE TUMOR BIOPSY SHOWING EXTENSIVE AREAS OF BROAD COAGULATIVE NECROSIS WITH FOAMY HISTIOCYTES. PATIENT ALSO HAD A REACTIVE AXILLARY LYMPH NODE WITHOUT LYMPHOMA INVOLVEMENT. FOLLOWING SURGERY, THE PATIENT NOTED REDUCED SWELLING AND PAIN. A SIX-WEEK FOLLOW-UP EXAMINATION REVEALED NO INFLAMMATION, REDUCED PAIN LEVELS, AND NO EVIDENCE OF RECURRENCE. NO AXILLARY OR SUPRACLAVICULAR PATHOLOGICAL LYMPHADENOPATHY WAS SEEN. THE PATIENT WAS FOLLOWED UP AT A SIX-MONTH INTERVAL FOR FIVE YEARS. CURRENTLY, THE PATIENT IS FOLLOWED UP YEARLY, AND REMAINS IN REMISSION AT YEAR SIX.
HEALTHCARE PROFESSIONAL REPORTED VIA LITERATURE ARTICLE "A SOUTH AFRICAN BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA: CLINICAL PRESENTATION AND SIX-YEAR FOLLOW-UP": PATIENT PRESENTED WITH INITIAL SWELLING OF THE LEFT BREAST. MAMMOGRAPHY, ULTRASOUND, AND MRI REVEALED A PERIPROSTHETIC FLUID COLLECTION AND MASS-LIKE ENHANCEMENT ON THE LEFT BREAST SHOWING SUSTAINED PERIPHERAL ENHANCEMENT. BIOMARKERS CD30+ AND ALK- WERE RECEIVED, INDICATIVE OF BIA-ALCL. THE PATIENT UNDERWENT ¿EN BLOC¿ CAPSULECTOMY. SURGERY AND RECOVERY WERE UNEVENTFUL. THE CAPSULECTOMY REVEALED FIBROUS CONNECTIVE TISSUE WITH THE TUMOR BIOPSY SHOWING EXTENSIVE AREAS OF BROAD COAGULATIVE NECROSIS WITH FOAMY HISTIOCYTES. PATIENT ALSO HAD A REACTIVE AXILLARY LYMPH NODE WITHOUT LYMPHOMA INVOLVEMENT. FOLLOWING SURGERY, THE PATIENT NOTED REDUCED SWELLING AND PAIN. A SIX-WEEK FOLLOW-UP EXAMINATION REVEALED NO INFLAMMATION, REDUCED PAIN LEVELS, AND NO EVIDENCE OF RECURRENCE. NO AXILLARY OR SUPRACLAVICULAR PATHOLOGICAL LYMPHADENOPATHY WAS SEEN. THE PATIENT WAS FOLLOWED UP AT A SIX-MONTH INTERVAL FOR FIVE YEARS. CURRENTLY, THE PATIENT IS FOLLOWED UP YEARLY, AND REMAINS IN REMISSION AT YEAR SIX.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2061037 | UNK MAMMARY IMPLANT | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | ALLERGAN (COSTA RICA) | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Female | Life Threatening |