MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) UNK GEL BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	UNK GEL BREAST IMPLANT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Lymphoma (3263)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Article citation: increased prevalence of brca1/2 mutations in women with macro-textured breast implants and anaplastic large cell lymphoma of the breast.Authors: de boer mintsje; van der hulst rene rwj; hauptmann michael; hijmering nathalie j; van noesel carel j m; rakhorst hinne a; meijers-heijboer hanne ej; boer jan paul de; de jong daphne; van leeuwen flora e.American society of hematology.Tracking no: bld-2019-004498r3.The event of lymphoma-alcl is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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 due to "anaplastic large cell lymphoma of the breast.".
Event or Problem Description
Journal article: "increased prevalence of brca1/2 mutations in women with macro-textured breast implants and anaplastic large cell lymphoma of the breast.".The article discusses 17 cases of bi-alcl and examines whether brca1/2 mutation carriership increases the risk of bia-alcl in women with implants.The article does not provided confirmation of diagnosis histological markers cd30+ and alk-.This records relates to case 4.The patient has brca1 exon 11 c.4097-1g>a splicing (49%) at alamut/ ncbi and had a left-sided mastectomy for breast cancer.Patient had breast implants at [age] and was later diagnosed with bia-alcl in the left breast.Location of the device has not been specified.

• Brand Name: UNK GEL BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 10224145
• Report Number: 9617229-2020-09911
• Device Sequence Number: 2279764
• Product Code: FTR
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: UNK GEL BREAST IMPLANT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 07/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention