MAUDE Adverse Event Report: MENTOR SMOOTH SILICONE BREAST IMPLANT

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

Patient Problems Autoimmune Disorder (1732); Fatigue (1849); Toxicity (2333); Malaise (2359); Heavier Menses (2666); Alteration In Body Temperature (2682); No Code Available (3191)

Event Date 05/01/2014

Event Type  Injury  

Event Description

After being implanted with silicone breast implants (cohesive gel by mentor) i became incredibly sick and my body started having a six-year downward spiral of auto-immune issues, endocrine issues, and adrenal dysfunction.Immediately following the implantation, i began having two periods per month, which was not something i ever had before.I told my plastic surgeon about it, said i was concerned but he brushed it off and said it was not related, even though it began right after implantation.Following this initial symptom, i was then diagnosed, three years later with endometriosis, adrenal fatigue, auto-immune disorder and was living with over 30 auto-immune symptoms that i never had prior to implant.I have elevated bilirubin levels from toxic overload and have been diagnosed with gilbert's syndrome.I did not smoke, do not use drugs, do not consume alcohol and eat very clean.I was a very healthy, active person up until all of this happened.At the time year mark of getting implants, after being diagnosed with all of these issues, i saw multiple doctors and kept telling them i have a concern it was my implants making me sick.None of them would even acknowledge it because they said "all implants are fda approved" and then would change the subject.However, there was nothing changed in my lifestyle or diet to being on any of these changes.This past year has been the worst so far and i just explanted without replacing the implants because i am 100% certain they have been poisoning me and i am disgusted how the medical industry does not take these type of complaints seriously.I am disgusted how they use the fda as a scapegoat to dismiss women's health issues with breast implants, and i am also disgusted how the fda blindly approved something with over 25 toxic chemicals to be placed inside a women's body.Not every women is genetically the same and there are many that will not be able to tolerate the implants.Since explanting, i already am noticing symptoms subsiding such as my brain fog, temperature regulation and ability to focus clearly.I am carefully monitoring my progress but something needs to be done about this as i am one of thousands upon thousands of women who have all had this same problem.I lost six years of my life to the implants and now am being told i have to have a hysterectomy from the endometriosis that was brought on by the increased periods that were triggered from the endocrine disruption from the implants.I am only (b)(6) and should not have any of these health issues.

• Brand Name: SMOOTH SILICONE BREAST IMPLANT
• Type of Device: SMOOTH SILICONE BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6607428
• MDR Text Key: 76710704
• Report Number: MW5070135
• 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: 05/31/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 33 YR
• Patient Weight: 53