MAUDE Adverse Event Report: SILIMED/ SIENTRA, INC. COHESIVE GEL SILICONE BREAST IMPLANTS

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Chest Pain (1776); Diarrhea (1811); Dry Eye(s) (1814); Fatigue (1849); Muscle Weakness (1967); Necrosis (1971); Pain (1994); Raynauds Phenomenon (2034); Swelling (2091); Anxiety (2328); Sleep Dysfunction (2517); Confusion/ Disorientation (2553)

Event Date 03/01/2007

Event Type  Injury  

Event Description

I had silimed smooth cohesive gel silicone implants put in (b)(6) 2006.I was put on a 10 yr study by the company, but was told they didn't need to follow me after about 4 yrs.By the 1st year of being followed, i had developed joint pain.Although mild at first my symptoms over the past 9 yrs have progressed significantly.The past 3 or 4 years, i have suffered with debilitating joint pain and stiffness, muscle pain, joint swelling, horrible insomnia, extreme fatigue, dry eyes, constant diarrhea, anxiety, brain fog, muscle weakness, raynauds disease.Right sided chest pain and right sided abdominal pain just under the right implant.I have been to multiple specialists including 3 rheumatologists and had hundreds of labs, xrays and other testing.Always to be told everything is normal.I feel like my body is attacking itself with no explanation.I did test positive for a gene called hla b27, but everything else is "normal." a few weeks ago, i had a natural healing woman tell me she was pretty sure it's my implants and i have since been researching it a lot! i was amazed to read of thousands of other women with the exact same unexplained symptoms.I am currently working on getting all my records from the past 10 years and seeing a plastic surgeon for explantation.I have had to take narcotic pain medications daily for the past 2 years just to be able to work, and have been on so much prednisone for the joint pain that i now have bilateral avascular necrosis in both hips that may require surgery to fix.I have spent (b)(6) of dollars with no answers, have suffered greatly and now need to figure out how i am going to come up with thousands more to get them out.More research has got to be done.Thousands of women are suffering and going broke and destroying relationships.

• Brand Name: COHESIVE GEL SILICONE BREAST IMPLANTS
• Type of Device: COHESIVE GEL SILICONE BREAST IMPLANTS
• Manufacturer (Section D): SILIMED/ SIENTRA, INC.
• MDR Report Key: 5842969
• MDR Text Key: 51226262
• Report Number: MW5063797
• 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: 07/29/2016
• 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: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/29/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 43 YR
• Patient Weight: 70