MAUDE Adverse Event Report: MENTOR GEL BREAST IMPLANTS

Lot Number 5930353

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Swelling (2091); No Code Available (3191)

Event Type  No Answer Provided  

Event Description

Approx 7 years ago, i had a breast augmentation done, re-done actually.I went from saline smooth implants to textured cohesive gel implants.Within a matter of months, i was already having problems with them the right breast became hard and it wasn't until this year that i had the funds to have them removed.During the last few years, i've had a swollen lymph gland underneath my right arm that repeatedly i was told was benign and nothing to worry about.Now that i've seen the reports on tv and the studies associating silicone implants with a certain type of cancer.I was wondering what steps to take to ensure that i was healthy and safe.I've been to the doctor many times complaining about the lymph gland being swollen and getting dismissed repeatedly, i could really use to use some advice or support.

• Brand Name: GEL BREAST IMPLANTS
• Type of Device: GEL BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6584830
• MDR Text Key: 75856801
• Report Number: MW5069936
• Device Sequence Number: 1
• Product Code: FTR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/19/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 5930353
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/19/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 72