MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC; BREAST IMPLANT

Catalog Number 350-7300BC

Device Problem Material Rupture (1546)

Patient Problems Breast Cancer (1759); No Code Available (3191)

Event Date 01/17/2017

Event Type  Injury  

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 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.

• Type of Device: BREAST IMPLANT
• Manufacturer (Section D): MENTOR WORLDWIDE LLC; 3041 skyway circle; north irving TX 75038 3540
• Manufacturer (Section G): MENTOR WORLDWIDE LLC; 3041 skyway circle; north irving TX 75038 3540
• Manufacturer Contact: joaquin kurz ; north irving, TX 75038-3540 ; 9497893837
• MDR Report Key: 6378474
• MDR Text Key: 69092786
• Report Number: 1645337-2017-00013
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 350-7300BC
• Device Lot Number: 5566433
• Other Device ID Number: 350-7300BC
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 63 YR