MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC; BREAST IMPLANT

Catalog Number	350-7300BC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Breast Cancer (1759); No Code Available (3191)
Date of Event	01/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.(b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient with history of breast prosthesis implantations was diagnosed with left breast cancer.The patient was implanted with mentor smooth round gel mammary prostheses on (b)(6) 2005.(catalog # 350-7300bc, serial number left side (b)(4) and serial number right side (b)(4)).The patient had a mammogram done on 10/20/2015 that showed ¿some micro calcifications in the left superior breast¿ and recommended patient attempt to obtain prior mammogram images for comparison and for additional imaging (spot magnification views) to evaluate the micro calcifications.They also recommended ultrasound at the discretion of the radiologist.Conclusion on calcifications was bi-rads category: 0- incomplete: needs additional imaging evaluation.Additional mammograms were done on (b)(6) 2016 and (b)(6) 2017.A bilateral breast mri was done on (b)(6) 2017 due to recent diagnosis of left breast cancer (exact date of diagnosis is unknown) the mri was done to assess extent of disease and for possible contralateral disease.Mri confirmed that bilateral implants were ruptured.Mri report ((b)(6) 2017) cites patient had augmentation revision procedure in 2008 (no further information stated; no information on types or brand of implants used).The patient has no family or personal history of breast cancer before this diagnosis.Patient advised that she had not selected an explant surgeon or explant surgery date as of yet.Mentor made a decision to file a fda medwatch report based on the above information; however, currently, there is no solid evidence in the literature to suggest that breast implant rupture alter the risk of breast malignancies.

• Common Device Name: BREAST IMPLANT
• Manufacturer (Section D): MENTOR WORLDWIDE LLC; 3041 skyway circle; north irving TX 75038 3540
• MDR Report Key: 6378474
• Report Number: 1645337-2017-00013
• Device Sequence Number: 1305520
• Product Code: FTR
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2017

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 350-7300BC
• Device Lot Number: 5566433
• Other Device ID Number: 350-7300BC
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2017
• 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: Life Threatening; Required Intervention
• Patient Age: 63 YR