FDA Adverse Event Injury Summary report: N

BREAST IMPLANT

MDR report key: 9763894 · Received February 26, 2020

Report

Report Number
MW5093336
Event Type
Injury
Date Received
February 26, 2020
Date of Event
September 25, 2019
Report Date
February 24, 2020
Manufacturer
JOHNSON & JOHNSON / MENTOR WORLDWIDE LLC
Product Code
FTR
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
NY, US
Reporter Occupation
PHYSICIAN ASSISTANT

Narratives

Description of Event or Problem · 1

ON (B)(6) 2019 SHE PRESENTED WITH SWELLING LARGE SEROMA OF THE LEFT RECONSTRUCTED BREAST WHICH HAD INCREASED IN SIZE OVER THE PAST 3 WEEKS. SHE HAD MENTOR SILTEX TEXTURED IMPLANTS IN PLACE. FLUID ASPIRATION (B)(6) 2019 CAIRO DIAGNOSTICS FLOW CYTOMETRY CASE # (B)(4) HYPOCELLULAR SAMPLE WITH A POPULATION OF CD30+ LARGE T CELLS, COMMENT: THE FINDINGS ARE CONSISTENT WITH ANAPLASTIC LARGE T-CELL LYMPHOMA. SURGICAL PATHOLOGY: WS19-22475, ORDER: (B)(4), COLLECTED: (B)(6) 2019 21:33, STATUS: FINAL RESULT, HISTORY OF MALIGNANT NEOPLASM OF FEMALE COMPONENT FINAL DIAGNOSIS: A) BREAST, RIGHT, IMPLANT AND CAPSULE, EXCISION: DENSE FIBROUS CONNECTIVE ADIPOSE TISSUE CONSISTENT WITH CAPSULE. NO EVIDENCE OF ANAPLASTIC LARGE CELL LYMPHOMA. ASSOCIATED SKIN AND SKELETAL MUSCLE. B) BREAST, LEFT, IMPLANT AND CAPSULE, EXCISION: PORTION OF DENSE FIBROUS CONNECTIVE ADIPOSE TISSUE CONSISTENT WITH CAPSULE. FOCAL FIBRINOINFLAMMATORY EXUDATE. NO EVIDENCE OF ANAPLASTIC LARGE CELL LYMPHOMA, SEE COMMENT, COMMENT: IMMUNOHISTOCHEMICAL STAINS FOR CD30 AND ALK ARE PERFORMED ON REP SECTIONS AND ARE NEGATIVE. IMMUNOHISTOCHEMICAL STAINS FOR CD3 AND CD20 SHOW THE PRESENCE OF SCATTERED BENIGN B AND T CELLS. AN IMMUNOHISTOCHEMICAL STAIN FOR CD68 SHOWS THE PRESENCE OF ABUNDANT HISTOCYTES. POSITIVE AND NEGATIVE CONTROLS ARE PERFORMED AND SHOW APPROPRIATE RESULTS. C) BREAST, LEFT MASTECTOMY FLAP MEDIAL TISSUE, EXCISION: PORTION OF DENSE FIBROUS CONNECTIVE ADIPOSE TISSUE SHOWING NO SIGNIFICANT PATHOLOGIC CHANGE. D) BREAST, PERIPROSTHETIC FLUID, REMOVAL: FLUID SUBMITTED FOR FLOW CYTOMETRIC STUDIES. GROSS DIAGNOSIS ONLY. E) BREAST, LEFT, SKIN DRAIN SITE, REEXCISION: FRAGMENT OF SKIN AND SOFT TISSUE SHOWING FOCAL DERMAL AND SUBCUTANEOUS TISSUE CHRONIC INFLAMMATION AND FAT NECROSIS. REPORTED BY (B)(6), MD ON 10/30/2019 AT 17:41 ELECTRONICALLY SIGNED BY (B)(6), MD ON 10/30/2019 AT 1741 -CYTOGENETICS (KARYOTYPE/MICROARRAY): WG19-01115, ORDER: (B)(4) - REFLEX FOR ORDER (B)(4), COLLECTED: (B)(6)2019 21:33, STATUS: FINAL RESULT, VISIBLE TO PT: YES (MYCHART) DX: HISTORY OF MALIGNANT NEOPLASM. ON (B)(6) 2014 LEFT THERAPEUTIC MASTECTOMY (INVASIVE DUCTAL CARCINOMA) WITH SENTINEL LYMPH NODE BIOPSY, RIGHT PROPHYLACTIC MASTECTOMY. IMMEDIATE BILATERAL BREAST RECONSTRUCTION WITH INSERTION OF ALLERGAN MX TISSUE EXPANDER AND MESOBIOMATRIC ACELLULAR DERMAL MATRIX; (B)(6) 2015 REMOVAL OF BILATERAL BREAST TISSUE EXPANDERS WITH PLACEMENT OF MENTOR SILTEX IMPLANTS (B)(6) 2015 REVISION OF RIGHT RECONSTRUCTED BREAST WITH DRAINAGE OF SEROMA AND INSERTION OF NEW MENTOR SILTEX IMPLANT. FDA SAFETY REPORT ID# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
222640 BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR JOHNSON & JOHNSON / MENTOR WORLDWIDE LLC
222641 TISSUE EXPANDER EXPANDER, SKIN, INFLATABLE FTR ALLERGAN 354-7001
222642 MENTOR WORLDWIDE LLC SILTEX IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR JOHNSON & JOHNSON / MENTOR WORLDWIDE LLC
222643 MENTOR WORLDWIDE LLC SILTEX IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR JOHNSON & JOHNSON / MENTOR WORLDWIDE LLC

Patients

Seq Age Sex Outcome Treatment
1 60 YR Other