MAUDE Adverse Event Report: MENTOR BREAST IMPLANTS; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Lot Number 5593781

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Apnea (1720); Fatigue (1849); Hair Loss (1877); Headache (1880); Unspecified Infection (1930); Memory Loss/Impairment (1958); Pain (1994); Rash (2033); Respiratory Distress (2045); Skin Irritation (2076); Anxiety (2328); Chest Tightness/Pressure (2463); Cognitive Changes (2551); Alteration In Body Temperature (2682)

Event Date 07/01/2017

Event Type  Injury  

Event Description

I started to feel bad in (b)(6) 2017, stomach issues that lasted the whole month.I ended up going to a gastroenterologist and was diagnosed with ibs.Then starting in (b)(6) 2017 i had what i thought was a sinus infection.Extreme fatigue, sinus pain and achy.Two prescriptions later and the symptoms never went away.Saw an ent and was told i needed to get my deviated septum fixed and that's why i was so tired and had sinus pain.He believed i had sleep apnea.Had my surgery in (b)(6).No relief after surgery.As the months continued i still suffered from extreme fatigue, joint and muscle pain, and sinus issues.Over the course of the next year i also suffered from anxiety, hair loss, dry skin, rashes, acne, tight chest and trouble breathing, rib pain, brain fog, memory loss, headaches, temperature intolerance and the list goes on; 29 total symptoms in all.In 15 months, i saw 6 different drs and had multiple blood tests done.Never getting a diagnosis because my blood work was always negative.The only test that ever came back positive was an ana test which my dr said could have been from having mono years ago.In (b)(6) 2018, i came across a website about breast implant illness.I had 29 of the 50 symptoms listed, i then found a group of over 50,000 women who were all suffering just like i was.I met with two surgeons which confirmed breast implant illness for me and i then scheduled my surgery for (b)(6) 2018.I am two weeks out from surgery and i am healing every day.Some symptoms have already gone away and some have gotten better.My mentor saline implants that i got back in (b)(6) 2008 were making me extremely sick.

• Brand Name: BREAST IMPLANTS
• Type of Device: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR
• MDR Report Key: 8023735
• MDR Text Key: 125914444
• Report Number: MW5080954
• Device Sequence Number: 1
• Product Code: FWM
• 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: 10/28/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Lot Number: 5593781
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Disability
• Patient Age: 35 YR
• Patient Weight: 56