MAUDE Adverse Event Report: MENTOR PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

Patient reported "got mentor saline implants in 2006, after surgeon shopped for young girls in night club offering group discounts.Two months after, i started getting lesions and memory loss.I had a nervous break down before year was over and had to quit job.I thought i was loosing my mind.I developed anxiety badly and because of life i just thought it was me.I became pregnant 6 months later after implants, had good pregnancy but when i began breastfeeding, my right side would get infected often and i would fall sick like flu but continued to breast feed through it.After i have done breast feeding, i went back to ps to have removed.He said i would be deformed with scars and suggested smaller implants (silicone natrelle) and a mesh lift" against a non allergan device.This record is for the right side.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Type of Device: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR
• MDR Report Key: 17532654
• MDR Text Key: 321134886
• Report Number: MW5139561
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1