MAUDE Adverse Event Report: MENTOR SMOOTH SALINE BREAST IMPLANTS

Model Number 1800 ROUND

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

Patient Problems Abscess (1690); Anaphylactic Shock (1703); Autoimmune Disorder (1732); Capsular Contracture (1761); Dry Eye(s) (1814); Fall (1848); Fatigue (1849); Pain (1994); Pneumonia (2011); Vertigo (2134); Blurred Vision (2137); Anxiety (2328); Depression (2361); Disability (2371); Sleep Dysfunction (2517); Cognitive Changes (2551); Weight Changes (2607)

Event Date 01/14/1992

Event Type  Injury  

Event Description

Mentor combo gel silicone/saline mammary prosthesis x 2, above muscle did not feel well, developed a severe capsular contracture.Re-do surgery done on (b)(6) 1993.Sub pectoral saline implants x 2 replaced and old ones taken out.On 1998 - experienced cfs, brain fog and was disabled.I am an rn, i returned to work following year 1999.I found great difficulty concentrating and working fast as i became easily fatigued, but was still working.I used to work 80 hours a week and raised 4 children alone.It was not feeling well at all.I was getting pneumonia 10 times a year, could not work as much, suffered cognitive difficulties interfering with a high tech job.By 2004 - i found it impossible to work at all, i was only (b)(6).I was depressed, no one knew what was wrong.I saw many md's, i was falling.I broke my foot, balance off, and felt horrible.By 2006 i was on ssdi and have been since that time.I have been diagnosed with panic attacks, multiple sclerosis, r/a, fibromyalgia, chronic fatigue syndrome, raynaud's disease, thoracic outlet syndrome, chronic insomnia.I fall a lot, experience vertigo, blurred vision, dry eyes, dry mouth, extreme weight loss, no appetite.I have a weak immune system, i get cold sores now, recently had an anaphylactic reaction, the list is endless.I want my breast implants out, as i feel that i may get my life back.Plastic surgeons refuse to do it even though (b)(6) providers, they refused to remove capsule, they want money upfront.(b)(6).I am bedridden and in a state of intractable pain.I recently fell on (b)(6) 2017 - saw a md next day.Report physical symptoms of severe back, breast, thoracic rib pain, neck pain, difficulty sleeping and i told him that i thought left implant had a slow leak.He did no physical exam, but did say that he had never seen (b)(6) pay for removal.By sunday (b)(6) left implant was deflated, there was bruising of breasts from traumatic fall.On monday (b)(6) 2017, i went to (b)(6).Chief resident dr.(b)(6) - verified breast deflation, but did not allow an appt, that is coveted by (b)(6).He sent me on a chase for medical records 23 years old.I told him i was in severe pain, valve from implant was bothering me.I made several call backs, no assistance.I started to experience a change in right breast? capsule had gone away? a firm capsule was there? i questioned whether this implant was leaking as well.I went to see dr.(b)(6) in (b)(6).On (b)(6) 2017 he is a (b)(6) provider and had spoken to me prior.I have an abscess filled with pus on left breast and told him i felt right really had changed - he wanted money up front and also stayed along with dr.(b)(6) that capsule did not need to come out.I am now in addition to suffering from a myriad of diseases (some not confirmed via scans etc) suffering from extreme stress, case has been escalated with (b)(6) and right implant has deflated on this date of (b)(6) 2017.No doctor will address issues, none - not even physical.I was forced to go to er on (b)(6) 2017, and then to top it off, they are not staffed with an er md? a nurse since (b)(6), i find this deeply disturbing.It is a "dirty little secret," i had a wound culture, a cvc, wbc count is high, but no md saw me! i was crying in pain, and reporting right breast issues, as well as left.(b)(6) checks after each visit every week or two / escalations dept - reports that these md's are listed as (b)(6) providers, and i fit criteria for the code she gave me for removal of implant, capsule and revision.Scar tissue is forming in left breast around implant and now looks deformed, valve is jabbing my ribs.Right implant is deflated.I have a high fever, infection, and valve on right breast is jabbing me.I am bedridden at (b)(6).I look 45 years old.This sickens me.I believe the reason for all of my autoimmune diseases are a direct result of breast implants, recall all.Too many over all of these years to list, but everything you can think of.Not to mention people thinking you are imagining all of this.I feel all breast implants are dangerous and are killing women.All implants for breasts, saline, silicone, textured and smooth, should be recalled and all parent companies should pay.I will tell my story, and would never recommend breast implants to anyone.I am an or/icu rn.How many women must get sick? how many of us must suffer because we do not have money to pay to have them removed? those that do are lucky.They are getting better? they are able to live again? i want my life back, or at least the chance.Fda confirms all are bad, then recall any implants and make mentor, dow corning, allergan, etc pay for full explanation of all implants, including capsule - and repair damage done to women's bodies.No one should have to live like this, no one should.It is despicable.Please do something.(b)(6) rn, bsn, ccrn, bs.

• Brand Name: SMOOTH SALINE BREAST IMPLANTS
• Type of Device: SMOOTH SALINE BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6585642
• MDR Text Key: 75854946
• Report Number: MW5069956
• 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: 05/19/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1800 ROUND
• Device Catalogue Number: 350-1880-M
• Device Lot Number: 83182
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 30 YR
• Patient Weight: 45