STYLE 153 SILICONE GEL FILLED BREAST IMPLANT

Report

• Report Number: 9617229-2016-00189
• Event Type: Injury
• Date Received: December 2, 2016
• Date of Event: July 2, 2016
• Report Date: December 2, 2016
• Manufacturer: ALLERGAN (COSTA RICA)
• Product Code: FTR
• PMA / PMN Number: P020056
• Adverse Event: Yes
• Report Source: Manufacturer report
• Reporter Location: MI, US
• Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ARTICLE CITATION: "LONG-TERM OUTCOMES WITH THE MCGHAN STYLE 153 DUAL-LUMEN BREAST IMPLANT: IMPLICATIONS FOR FUTURE IMPLANT DESIGN,¿ BY DC HAMMOND AND WP SCHMITT, PUBLISHED IN J PLAST RECONSTR AESTHET SURG, ELECTRONICALLY PUBLISHED 07/02/2016. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENTS OF LYMPHOMA AND SEROMA ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING: POTENTIAL ADVERSE EVENTS THAT MAY OCCUR WITH SILICONE GEL-FILLED BREAST IMPLANT SURGERY INCLUDE: IMPLANT RUPTURE, CAPSULAR CONTRACTURE, REOPERATION, IMPLANT REMOVAL, PAIN, CHANGES IN NIPPLE AND BREAST SENSATION, INFECTION, SCARRING, ASYMMETRY, WRINKLING, IMPLANT DISPLACEMENT/MIGRATION, IMPLANT PALPABILITY/VISIBILITY, BREASTFEEDING COMPLICATIONS, HEMATOMA/SEROMA, IMPLANT EXTRUSION, NECROSIS, DELAYED WOUND HEALING, BREAST TISSUE ATROPHY/CHEST WALL DEFORMITY, CALCIUM DEPOSITS, AND LYMPHADENOPATHY. BASED ON INFORMATION REPORTED TO FDA AND FOUND IN MEDICAL LITERATURE, A POSSIBLE ASSOCIATION HAS BEEN IDENTIFIED BETWEEN BREAST IMPLANTS AND THE RARE DEVELOPMENT OF ANAPLASTIC LARGE CELL LYMPHOMA (ALCL), A TYPE OF NON-HODGKIN¿S LYMPHOMA. WOMEN WITH BREAST IMPLANTS MAY HAVE A VERY SMALL BUT INCREASED RISK OF DEVELOPING ALCL IN THE FLUID OR SCAR CAPSULE ADJACENT TO THE IMPLANT. ALCL HAS BEEN REPORTED GLOBALLY IN PATIENTS WITH AN IMPLANT HISTORY THAT INCLUDES ALLERGAN¿S AND OTHER MANUFACTURERS¿ BREAST IMPLANTS. YOU SHOULD CONSIDER THE POSSIBILITY OF ALCL WHEN YOU HAVE A PATIENT WITH LATE ONSET, PERSISTENT PERI-IMPLANT SEROMA. IN SOME CASES, PATIENTS PRESENTED WITH CAPSULAR CONTRACTURE OR MASSES ADJACENT TO THE BREAST IMPLANT. WHEN TESTING FOR ALCL, COLLECT FRESH SEROMA FLUID AND REPRESENTATIVE PORTIONS OF THE CAPSULE, AND SEND FOR PATHOLOGY TESTS TO RULE OUT ALCL. IF YOUR PATIENT IS DIAGNOSED WITH PERI-IMPLANT ALCL, DEVELOP AN INDIVIDUALIZED TREATMENT PLAN IN COORDINATION WITH A MULTI-DISCIPLINARY CARE TEAM. BECAUSE OF THE SMALL NUMBER OF CASES WORLDWIDE, THERE IS NO DEFINED CONSENSUS TREATMENT REGIMEN FOR PERI-IMPLANT ALCL. - ATTACHMENT: [ARTICLE - LONG-TERM OUTCOMES[...].PDF]

Description of Event or Problem · 1

REPORTED EVENTS OF ¿ANAPLASTIC LARGE CELL LYMPHOMA¿ AND ¿LATE SEROMA¿ OCCURRING WITH A MCGHAN STYLE 153 LUMEN DEVICE WAS FOUND WITHIN THE JOURNAL ARTICLE, ¿LONG-TERM OUTCOMES WITH THE MCGHAN STYLE 153 DUAL-LUMEN BREAST IMPLANT: IMPLICATIONS FOR FUTURE IMPLANT DESIGN¿ IN JOURNAL OF PLASTIC, RECONSTRUCTIVE, AND AESTHETIC SURGERY, 69, 02 JUL 2016 PP. 1211-1217. ARTICLE STATES: ¿ONE CASE (0.75%) OF ANAPLASTIC LARGE CELL LYMPHOMA WAS DIAGNOSED AFTER THE DEVELOPMENT OF A LATE SEROMA TEN YEARS POST-OPERATIVELY.¿ NO FURTHER INFORMATION IS PROVIDED. AS PATHOLOGICAL MARKERS CONFIRMING ALCL HAVE NOT BEEN RECEIVED, THE EVENT WILL BE CAPTURED AS LYMPHOMA. THE AFFECTED SIDE WAS NOT SPECIFIED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
792549	STYLE 153 SILICONE GEL FILLED BREAST IMPLANT	PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED	FTR	ALLERGAN (COSTA RICA)		NI

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention

Terms

Patient problem · 2

• Lymphoma
• Seroma

Product problems · 1

• No Apparent Adverse Event

Source type · 2

• HEALTH PROFESSIONAL
• LITERATUR

Type of report · 1

• Initial submission