FDA Adverse Event Injury Summary report: N

UNK GEL BREAST IMPLANT

MDR report key: 11118749 · Received January 5, 2021

Report

Report Number: 9617229-2020-21959
Event Type: Injury
Date Received: January 5, 2021
Date of Event: February 15, 2020
Report Date: January 5, 2021
Manufacturer: ALLERGAN (COSTA RICA)
Product Code: FTR
PMA / PMN Number: P020056
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IS
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE REPORTED EVENTS 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-SUSPECTED. ARTICLE CITATION: "PERSISTENT EXTRANODAL MARGINAL ZONE LYMPHOMA (MZL) IN THE CAPSULE OF A RE-EXPLANTED SILICONE PROSTHESIS FOLLOWING BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL)." HAR-SHAI LIOR, HAR-SHAI YARON, METANES ISSA, BRYZGALIN LEONID, HASSAN SAMER, SABO EDMOND, PREIS MEIR. IMAJ. VOL22. FEBRUARY2020.

Description of Event or Problem · 1

JOURNAL ARTICLE: PERSISTENT EXTRANODAL MARGINAL ZONE LYMPHOMA IN THE CAPSULE OF A RE-EXPLANTED SILICONE PROSTHESIS FOLLOWING BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA. LIOR HAR-SHAI, YARON HAR-SHAI, ISSA METANES, LEONID BRYZGALIN, SAMER HASSAN, EDMOND SABO AND MEIR PREIS. ISRAEL MEDICAL ASSOCIATION JOURNAL, VOLUME 22 (2) 130-131. HCP REPORTED "BIA-ALCL AND PERSISTENT EXTRANODAL MARGINAL ZONE LYMPHOMA." DEVICE WAS EXPLANTED AND REPLACED. MARKERS OF CD30+ OR ALK- HAVE NOT BEEN CONFIRMED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
13362	UNK GEL BREAST IMPLANT	PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED	FTR	ALLERGAN (COSTA RICA)		NI

Patients

Seq	Age	Sex	Outcome	Treatment
1			Life Threatening