MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3547007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); Pain (1994); No Code Available (3191)
Date of Event	02/04/1999
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: n/a.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old female patient underwent a breast augmentation revision with a mentor memorygel breast implant 700cc and suffered from generalized illness and breast pain.The patient experienced:¿ fatigue, brain fog, memory loss, muscle joint pain, hair loss, dry skin, pre-mature aging, weight problems, inflammation, rashes on body, insomnia, poor sleep, vertigo, nausea, gastral problems, pain in stomach, night sweat, intolerant to hot and cold, headaches, slow muscle recovery, heart palpation, anxiety, swollen lymph nodes, infections, gall bladder problems, depression, body aching, bruising easily, takes long to heal, respiratory problems, unable to breath, pain in chest, metallic taste, ear ringing, dehydration, tingling in arms and legs, arthritic pain, stabbing/aching sensation, stabbing pain, feels like she is dying¿.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This medwatch is for the right breast implant.
Additional Manufacturer Narrative
On 4/1/2020, a manufacturing record evaluation was performed for the finished device 178690 number, and no non-conformances were identified.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 5/20/2020, it was reported to mentor that the patient experienced capsular contracture.Therefore, codes breast pain, anisomastia were removed and code capsular contracture was added.Facility name: (b)(6).Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2021, it was reported to mentor that the date of implantation and the date of problem observed was (b)(6) 1999 per medwatch form mw5093724.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 9857643
• Report Number: 1645337-2020-04601
• Device Sequence Number: 11590164
• Product Code: FTR
• UDI-Device Identifier: 00081317000761
• UDI-Public: 00081317000761
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1999
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/25/2020

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 Expiration Date: 08/31/2003
• Device Model Number: 3547007
• Device Catalogue Number: 3547007
• Device Lot Number: 178690
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 04/01/2020; 05/20/2020; 08/18/2021
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 04/14/2020; 05/21/2020; 08/24/2021
• 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: Other
• Patient Age: 44 YR