MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC SILICONE BREAST IMPLANTS - SMOOTH ROUND HIGH PROFILE GEL; PROSTHESIS, BREAST, NONINFLATABLE, SILICONE GEL-FILLED

Model Number RT 350-3504BC

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

Patient Problems Autoimmune Reaction (1733); Fatigue (1849); Memory Loss/Impairment (1958); Pain (1994); Toxicity (2333); Numbness (2415)

Event Date 07/12/2017

Event Type  Injury  

Event Description

I am having a had reaction to my mentor silicone memory gel implants that were placed under the muscle three years ago.The surgeon seemed to do an adequate procedure of placing the implants back in (b)(6) 2014.Less than 6 months after having these implants, i started to develop multiple symptoms.It started with pain, fatigue, numbness, concentration, and memory loss, which has now triggered an autoimmune response and high levels of toxicity in my body.I had follow-ups with my surgeon and everything seemed to be fine but the symptoms continue to become worse and more frequent.In doing my research, i trusted the fdas recommendation that these were very safe implants.I have learned that the mentor company product was approved but was supposed to complete a 10 year study that has now been cancelled.I am ashamed of the mentor company because of the old and new medical research the proves these implants ar highly toxic.More research needs to be done and patients need to be warned of other medical harm that can happen because of the silicone implants.I researched and found tan excellent plastic surgeon.I was extremely healthy at time of the implant surgery and was told these were fda approved and very safe.I believed the fda and the plastic surgeon.I have followed every recommendation that has been made in regards to the breast augmentation surgery.I have also been very consistent with all of my medical visits and live a very healthy lifestyle however i continue to become more ill no matter how clean eating, exercising, and taking supplements and medication recommended by physicians.Besides seeing my primary care physician, i have seen a neurologist, rheumatologist, holistic/functional medicine, gynecologist, dermatologist, psychiatrist, therapist, chiropractor and have tried massage therapy, acupuncture, sauna, and more recently i saw a doctor at (b)(6) for heavy metal issues.Important information: i have been very diligent in following doctor's protocols and have preferred diet and exercise over medication if at all possible.I do not smoke cigarettes, and rarely ever drink any alcohol.In fact, since implantation i do not have a taste of alcohol and have become sick whenever i have tried to drink even in moderation.I have a supportive husband and family and have even resigned from my teaching position to help figure out my medical issues.

Event Description

Add'l info received for report mw5070992 on (b)(6) 2019.Reporter alleges after implants were taken out, the following symptoms resolved: joint pain, feet pain in both right and left, rashes on chest, face and back, no more flu like symptoms, insomnia went away, weight loss due to decreased inflammation, improvement in dry skin, yellowish eyes brightened to clear white, wound heals faster after explant and eyes are no longer dry.General improvement in health after explant, and has lab work to prove upon request.

• Brand Name: SILICONE BREAST IMPLANTS - SMOOTH ROUND HIGH PROFILE GEL
• Type of Device: PROSTHESIS, BREAST, NONINFLATABLE, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR WORLDWIDE LLC
• MDR Report Key: 6714016
• MDR Text Key: 80194807
• Report Number: MW5070992
• Device Sequence Number: 2
• Product Code: FTR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 12/04/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: RT 350-3504BC
• Device Catalogue Number: RT 350-3504BC
• Device Lot Number: RT 6815097
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 45 YR
• Patient Weight: 66