MAUDE Adverse Event Report: MENTOR SALINE BREAST IMPLANTS

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

Patient Problems Itching Sensation (1943); Loss of Range of Motion (2032); Rash (2033); Arthralgia (2355); Skin Inflammation (2443); Weight Changes (2607)

Event Date 05/10/2007

Event Type  Injury  

Event 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
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6562776
• MDR Text Key: 75144534
• Report Number: MW5069708
• Device Sequence Number: 1
• Product Code: FWM
• 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: 05/10/2017
• 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
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: VITAMIN D-3; RX MEDS: PRESCRIPTION MEDICATIONS.
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 61 YR
• Patient Weight: 60