MAUDE Adverse Event Report: ALLERGAN STYLE 115 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number 115-378

Device Problem No Apparent Adverse Event (3189)

Patient Problems Breast Mass (2439); Lymphoma (3263)

Event Date 04/15/2013

Event Type  Injury  

Manufacturer Narrative

Medwatch submitted: 05/20/2013. Allergan labeling addresses the event of breast lumps as follows: breast self-examinations: following breast augmentation, you should continue to perform breast self-examination monthly. This may be more difficult with a breast implant in place. To continue to perform a monthly breast self examination efficiently, you should ask your surgeon to help you identify the difference between the implant and your breast tissue. Being able to identify the implant from breast tissue will decrease the necessity of excessive squeezing of the implant during examination. Any new lumps should be evaluated with a biopsy, as appropriate. If a biopsy is performed, be sure to inform the medical professional performing the biopsy that you have breast implants so that care will be taken to avoid injuring the implant. The 410 device labeling addresses anaplastic large cell lymphoma (alcl): based on info 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 pts with an implant history that includes allergan's and other manufacturers' breast implants. You should consider the possibility of alcl when you have a pt with late onset, persistent peri-implant seroma. In some cases, pts 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 pt 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. For more complete and up-to-date info on fda's analysis and review of the alcl in pts with breast implants please visit: http://www. Fda. Gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/breastimplants/ucm239995. Htm.

Manufacturer Narrative

Allergan is submitting this follow-up mdr in accordance with 21 cfr 803 following the recall of biocell® textured breast implants and tissue expanders in relation to the uncommon incidence of breast implant-associated anaplastic large cell lymphoma (bia-alcl). Allergan did not submit this mdr within 30 days of allergan¿s decision to initiate the remedial action. Allergan has initiated an investigation to address late mdrs submitted related to 2011068-7/2/19-001-r.

Event Description

Allergan is submitting this follow-up mdr in accordance with 21 cfr 803 following the recall of biocell® textured breast implants and tissue expanders in relation to the uncommon incidence of breast implant-associated anaplastic large cell lymphoma (bia-alcl).

Event Description

Company rep reported right side anaplastic large-cell lymphoma and "subcutaneous nodules and lymph nodes. " the pt had a bilateral reconstruction seven years ago with style 410 breast implant placed on the left side and a style 115 placed on the right side. The pt had done well until she presented last week with a pathology report from her oncologist stating that she had alcl. The pt stated that she had nodules on the right axilla. A pet scan was carried out that showed metastasis in the lung and bone marrow involvement. No seroma was noted. The oncologist has decided on her treatment plan to exclude radiation. Explant surgery will take place (b)(6) 2013.

• Brand Name: STYLE 115 SILICONE GEL FILLED BREAST IMPLANT
• Type of Device: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer Contact: michelle burgess ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 3199749
• MDR Text Key: 10822419
• Report Number: 2024601-2013-00387
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional

Reporter Occupation

• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2013
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/24/2011
• Device Catalogue Number: 115-378
• Device Lot Number: 1267625
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2011068-7/2/19-001-R

Patient Treatment Data

Date Received: 05/20/2013 Patient Sequence Number: 1

Treatment

NO INFO.