MAUDE Adverse Event Report: SILICONE BREAST IMPLANT (RIGHT); PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Device Problem Insufficient Information (3190)

Patient Problems Dry Eye(s) (1814); Inflammation (1932); Muscle Weakness (1967); Pain (1994); Anxiety (2328); Cramp(s) /Muscle Spasm(s) (4521)

Event Type  Injury  

Event Description

I had symptoms of breast implant illness 2 years after receiving my silicone implants.Joint paint, dry eyes, anxiety, increased inflammation markers in my blood tests made me think i had fibromyalgia.This went on for years then finally had them removed.I still suffer 1 year later from these same symptoms.I have been tested for endocrine and arthritic diseases and tests always come back negative.I have muscle weakness and cramping and long term costochondritis.Bii(bii (breast implant illness)) is real.Yet the medical profession denies its existence.I say follow the money here.Manufacturers selling silicone implants make a lot of money selling these horrendous implant devices to doctors.The effect silicone implants has had on my health should be made criminal.How does this get ignored by fda? reference report: mw5116807.

• Brand Name: SILICONE BREAST IMPLANT (RIGHT)
• Type of Device: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• MDR Report Key: 16769862
• MDR Text Key: 313741480
• Report Number: MW5116808
• Device Sequence Number: 1
• 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
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: CELEBREX FOR JOINT PAIN; FISH OIL; VIT D
• Patient Outcome(s): Disability
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White