MAUDE Adverse Event Report: MENTOR SALINE BREAST IMPLANTS

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Itching Sensation (1943); Loss of Range of Motion (2032); Rash (2033); Arthralgia (2355); Skin Inflammation (2443); Weight Changes (2607)
Date of Event	05/10/2007
Type of Reportable Event	Serious Injury
Event or Problem Description
Mentor textured saline breast implants were placed in (b)(6) 1995 when i was (b)(6).Starting in 2007, (no exact date) i began having recurrent full-body itchy rashes; presented to my primary care practitioner and was referred to several dermatologists when topical and oral steroids failed to clear it.Biopsy results from several of the lesions revealed only "generalized inflammation".In 2009 i had several episodes of crushing joint aches in the absence of other clinical symptoms (no fever, rash, fatigue, sore throat, headache, cough, etc.) the only significant blood marker was a highly elevated c-reactive protein level, all other blood work was negative for any pathology.These incidences spontaneously resolved.At no time did i connect the rashes, joint aches, or weight gain (heck i thought it was menopause) to the breast implants.In early 2017 i decided to remove the implants as i was having pain in the right breast and limitation of arm range of motion.I went on a (b)(6) breast explant group to solicit recommendations for explant surgeons.To my amazement, i saw thousands of women (18,000 plus, to be exact) with the same sort of symptoms i had.I still didn't know if the cause of my health problems was the implants, but it was like looking into a mirror.At any rate, i explanted (b)(6) 2017.Rashes = gone.Joint aches = reduced by 50 percent at three weeks post-op.Weight gain - i had literally tried nearly every diet and exercise program that exists and maybe lost a pound or two with significant exercise.It's three weeks post-explant and i'm down 7 pounds with a completely sedentary existence while recovering from surgery.I suppose that it's only an anecdotal report and that correlation does not equal causation; and perhaps my symptoms were not due to breast implants, since i can't prove it.But do you really suppose that 18,000 plus women are all experiencing a placebo effect with amelioration of their symptoms?.

• Brand Name: SALINE BREAST IMPLANTS
• Common Device Name: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6562776
• Report Number: MW5069708
• Device Sequence Number: 14859375
• Product Code: FWM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1995
• Device Explanted Year: 2017
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 05/10/2017
• 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
• Operator of Device: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OTC MEDS: VITAMIN D-3; RX MEDS: PRESCRIPTION MEDICATIONS.
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 61 YR
• Patient Weight: 60