FDA Adverse Event Injury Summary report: N

NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS

MDR report key: 18990002 · Received March 27, 2024

Report

Report Number: MW5153280
Event Type: Injury
Date Received: March 27, 2024
Date of Event: March 25, 2024
Report Date: March 25, 2024
Manufacturer: ALLERGAN SALES, LLC
Product Code: FTR
Adverse Event: Yes
Product Problem: Yes
Report Source: Voluntary report
Reporter Location: WI, US
Reporter Occupation: PATIENT
Health Professional: *

Narratives

Description of Event or Problem · 0

I AM A BREAST CANCER RECONSTRUCTION PATIENT AND DISCOVERED A HARD LUMP IN IMPLANT (THAT MOVES AROUND A BIT); ALLERGAN SILICONE GEL IMPLANT HAS A RUPTURE INSERTED (B)(6) 2018 AND HAVE HAD SHOOTING NERVE PAIN IN LEFT ARMPIT FOR LAST SEVERAL WEEKS. ALSO SOME DISCOMFORT IN UPPER RIB AREA WHERE SCAR TISSUE IS WHERE INSERTED. I AM GETTING MAGNETIC RESONANCE IMAGING AND SURGERY CONSULT THIS WEEK TO HAVE SWIFTLY REMOVED (WILL HAVE BOTH REMOVED AS PRECAUTION). THIS IS AN IMPLANT THAT WAS RECALLED IN 2019 THAT I NEVER KNEW UNTIL TODAY WHEN I CALLED VAIL HEALTH WHO INSERTED IT (SURGEON RETIRED) I AM NOT HAPPY I DID NOT KNOW OF THESE COMPLICATIONS AND NOW HAVE TO BE TESTED FOR ANOTHER TYPE OF CANCER BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA, DUE TO SYMPTOMS. I HAVE ALREADY HAD MULTIPLE SURGERIES FOR RECON POST-MAST / LYMPH NODES, AND NOW HAVE TO GO UNDER AGAIN. REFERENCE REPORT: MW5153281.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1985405	NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS	PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED	FTR	ALLERGAN SALES, LLC	410 FF

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR	Female	Disability\| H	CYMBALTA.\| DAILY VITAMINS. \| GABAPENTIN.\| OCCIPATAL NERVE BLOCKS (PREV HEAD INJURY).\| OTHERS.\| PROLIA INJECTIONS.\| VITAMIN D.