Saline Breast Implants and Mold

Saline implants can have faulty valves that allow body fluid/tissue in and allow colonization of fungal microorganisms inside the implant. These microorganisms produce metabolites which are toxic to us known as mycotoxins.

The labels on the saline solution (pyrogen-free Sodium Chloride U.S.P. Solution for Injection) to fill the saline implants, recommend storage at 25°C (77°F) and include a discard date of about 18 months (sources: Mentor SSED see pg.15 and here). With these implants the saline is stored in the body at 98.6°F for many years. This makes the perfect breeding conditions for fungi and other microbes to grow.

Fungus thrives in warm and wet areas. Additionally, due to the immune deficits implants cause, there is an increased susceptibility to developing fungi (mold, yeast, etc) inside the body from contact with mold in the environment. There have been some cases of saline implants having mold from women in warm and humid environments such as Florida.

Mold can also occur in silicone implants as they disintegrate and allow body fluids to permeate the shell and implant. Textured implants, both saline and silicone, allow body fluids to be soaked up by the textured surfaces, and therefore this also attracts fungus and provides an ideal breeding ground.

Scientific Articles: 

The semi-permeability of silicone: a saline-filled breast implant with intraluminal and pericapsular Aspergillus flavus (2006). Link 1 and Link 2.

  • We report a case of Aspergillus flavus growth within and around a saline-filled breast implant that was inserted 18 months previously. Growth of fungi within the lumen of saline-filled implants has previously been demonstrated in laboratory studies.
  • This case re-iterates that the silicone envelope of a saline-filled implant is selectively permeable and we believe this is instrumental in facilitating intraluminal microbial growth.
  • There is an interesting association of saline-filled breast implants with fungal infection in the literature, suggesting that there may be some inherent characteristic of saline-filled implants that is conducive to fungal growth. We suggest that it is the selectively permeable nature of the silicone envelope of saline-filled breast implants that is responsible for facilitation of Aspergillus growth by diffusion of metabolites and perhaps by preventing antigen presentation from the lumen to immune cells.

Microbial growth inside saline-filled breast implants (1997). Link.

  • The data show that several types of bacteria (particularly gram-negative species) and fungi can grow and reproduce in a restricted saline environment for extended periods of time.

Aspergillus flavus cultured from a saline-filled implant (1997). Link.

Bacterial growth in saline implants: In vitro and in vivo studies (1996), Link.

Do Saline Breast Implants Harbor Microbes? (1996). Link

  • Recent anecdotal reports have indicated that a high percentage of saline implants harbor dangerous microbes. These reports have caused considerable alarm and fear to saline implant recipients. .

Paecilomyces variotii contamination in the lumen of a saline-filled breast implant (1995). Link.

  • This report describes a case of gross contamination with the filamentous fungus P. variotii cultured from an intraluminal saline breast implant removed from a patient 14 months after implantation because of severe capsular contracture.

Fungi In and Around Implants After Augmentation Mammaplasty (1980). Link.

Fungus 1978:

Mold from faulty valves has been recorded to be found in saline breast implants since as early as 1978. Although rare, it does continue to occur and is regularly suppressed and buried by the medical community. The following is an excerpt from page 269 of the book Breast Implants and the Document Investigation and Review Team Committee:

“…an implant put into a patient by Dr. Jenny was removed by a surgeon in Augusta, Florida. The explanted device contained growth, which was identified as a fungus.'” – Heyer-Schulte Interoffice Correspondence: (MD#121382 Date: December 21, 1978 #29).

Moldy implants could be from test batches of under cured prostheses. And over-curing has its own disadvantage, “… that the silica in the silicone can be released from its entrapped state by overcuring ….” (03/19/76. KMM 74769 Pendleton D. #223).

Dr. Pierre Blais:

He is a chemist and biocompatibility expert who has been analyzing breast implants for 30+ years. See an in-depth analysis report Dr. Blais did on a lady’s saline implants. Starting with page 13, general problems with saline implants are discussed including how microbiological growth can occur and problems with leaky valves. Samples of the writings are below:

“[N]early all saline inflatable devices examined to date show significant deficiencies with respect to the integrity of the shell, its ability to contain solutes and micro-organisms. The issue of valve competence is another major problem, in particular for more recent versions of these devices.

…Pathologic effects from bacterial, viral or fungal colonization of the capsule space leading to low grade chronic infections and toxic phenomena from microbiological metabolites. Users of saline-filled implants are particularly subject to such problems. Furthermore, many surgeons habitually incorporated pharmaceuticals such as anti-inflammatories and antibiotics with the aqueous solutions of such implants. These compounds degrade to comparatively toxic entities which add their effects to the previously-cited injuries.

…Contamination and colonization of the saline compartment takes place comparatively rapidly and depend on implantation techniques, valves design and position of the device with reference to the valve mechanism.

…Leaky valves allow inoculae from the interior to leak into the intracapsular space causing low grade infections. When shells eventually perforate, systemic symptoms generally develop. The event may not be immediately noticeable and the space originally filled with saline solutions will become filled with tissue debris and body fluids. These substances later decay and produce additional infective and immunological phenomena as they incubate over the long term. Movement from the user causes a type of ‘pumping’ action which leads to back and forth flow of biological fluids and decaying material entrapped within the porous, permeable or perforated shell.

…A noteworthy characteristic of saline-inflatable breast implants and tissue expanders filled with aqueous media is their ability to sustain microbiological activity within the saline containing compartment. Another is their susceptibility to rapidly lose their saline charge because of valve failure and/or shell deterioration culminating in shell perforation.

…Valve and saline compartment (outer lumen) contamination by micro-organisms, scar tissue and decaying proteinaceous debris as well as colonization of the interior of the prostheses by atypical flora is a major long term safety issue for aqueous media filled devices because the durability of the shell is very limited and release of the content is inevitable.”

Dr. Blais also wrote “Saline-filled breast implants – a continuing area of concern.”

FDA MAUDE – Adverse Reaction Reports –  Inclusive of Saline Implants & Mold:

Note: Parentheses represent redacted information to protect privacy.

1. It was reported that a (b)(6) female patient underwent bilateral breast prostheses implantation with mentor saline implants on (b)(6) 2005. Patient presented with bilateral implant deflation with defective valves. She also reported mold, fungus and bio-toxins were leaking into her body. Patient had implants explanted on (b)(6) 2014. No further information was obtained. Link.

2. It was reported that a female patient underwent a breast augmentation surgery using mentor saline smooth round moderate profile implants on (b)(6) 2003. The patient suffered sternal pain, mastodynia and mold infection manifested as enlarged lymph nodes, and was diagnosed bio-toxin disease in 2015. The implants were removed surgically on (b)(6) 2015 and found to have defective valves, internal debris and determined to have been leaking. Link.

3. I had saline breast implants put in my body almost 11 years ago. I have been sick with inflammation and countless symptoms for the past 10 years. My illness started to get worse as of last year. I started to smell like something was rotting in my body. I had began to feel very sick. I did my own research as my md’s were no help to me and found that my saline breast implants have been making me sick. I finally found a plastic surgeon that agreed with me and recommended an explant (removal) surgery. I had the surgery on (b)(6) 2012. After the surgery, my doctor showed me why i was so ill; she showed me my implants with mold fungus visible to the eye, had a very nasty smell to them. Pathology revealed that the implants had mold, fungus and (b)(6) in them. I also had a (b)(6) infection in my right breast due to the (b)(6) in the implant. My implants were made by mentor. I did a little research on mentor and found out that the company fired an employee for refusing to destroy documents containing that their implants had defective valves. My doctor also told me i had defective valves. So to sum it all up i had a slow leak of fungus, mold and (b)(6) over a very long period of time. Stop mentor from harming others!. Link.

4. In 2004 i had mentor breast implants. I began having various medical problems that were unexplained. Over time i suffered digestive problems, unexplained heart problems, autoimmune issues, rheumatic symptoms, memory issues, metal fog, etc. I had my implants removed (b)(6) 2013 and they were found to have defective valves with mold growing on them. Since having them removed, my symptoms immediately improved. I would like to be added to a list with the fda in the event they are ever recalled. Smooth round moderate profile. Link.

5. On (b)(6) 2002, pt stated she was implanted with mentor smooth saline breast implants during reconstructive surgery at the age of (b)(6). Immediately after, she suffered from: joint and muscle pain, neuro-cognitive changes, chronic fatigue, hair loss, light sensitivity, and vitiligo. She vomited at least 8 times a day and when she suffered from a cold, it would last 3 months. She states that she went from having an academic diction to having difficulty understanding commonly used words. She was also diagnosed with severe pulmonary hypertension. She also suffered with ambulation difficulties and had the feeling of walking on broken glass. On (b)(6) 2005, she had the implants removed. Upon removal of her implants, all neurological symptoms dissipated. However, fatigue, mild joint pain, infertility, hair loss, and an impaired immune system did remain. The explanted silicone shells of the implants were visibly thinner. There was green mold lodged in the valves, there were two white strings found in the saline and a considerable amount of the saline inside the implants had leaked out. On (b)(6) 2010, pt states that she then went in for additional surgery to remove scar tissue. She said scar capsules were found from her neck to the sides of the ribs. Immediately afterwards, she no longer had any of the symptoms and her pulmonary hypertension was diagnosed as mild. She had undergone antifungal treatment due to a diagnosis of systemic candidiasis at this time; she said that she was completely cured of her pulmonary hypertension. She is hla dr52 positive which, she states, is linked to a severe auto-immune response following the introduction of breast implants. She said that a simple test could have warned her of how her individual immune system would react to the silicone, thus saving her from the toll it took on her immune system, brain, and heart. Link.

6. In 2008, i had smooth saline implants put in, made mentor. Within in several months of having the implant put in, i started experiencing chronic fatigue. I spent months going to different doctors trying to find out why i felt so bad. During that time i was diagnosed with ibs syndrome. My eyes and mouth became very dry. I had to have plugs put into my tear ducts. In 2011, i experienced vertigo. I was unable to function. I was having breast pain in my right breast, i was fatigued. I got to where i could not swallow, i had shortness of breath, anxiety attacks, depression, memory loss and confusion. My feet and hands hurt, i could barely walk. I was told i had chronic fatigue syndrome and fibromyalgia. From (b)(6) 2008 until (b)(6) 2011, i seen around 10 or more doctors with many expensive test done. No one was able to diagnose the cause of my problems, until (b)(6) 2011, when i was told i had biotoxicity illness from my breast implants. At this point i could barely function. I was put on a detox program, to get the fungus and mold out of my body and then on (b)(6) 2011, i had the implants removed. I found out after surgery that i had a (b)(6) infection in my right breast. This had contributed to a lot of my pain and sickness. Two months after surgery i am almost 100% back to my old self. I am outraged that these companies that make breast implants are allowed to keep doing this to women. I read about women everyday that are sick from their implants and no one will help them. I was told i could not file a law suit because the time for that had past. Not only did i almost lose my life because of those toxic bombs, it also put a financial burden on my family. Somebody needs to be held accountable. Dates of use: 3 years; (b)(6) 2008 – (b)(6) 2011. Link.

7. About 23 years ago i was implanted with (b)(4) saline breast implants. I have been diagnosed with 4 autoimmune diseases and sick and disabled for 4 years. I have seen many doctors with the conclusion being they don’t know what is causing me to be ill. On (b)(6) i traveled out of state to have my implants removed by a surgeon highly qualified to do the proper en bloc/capsules removed procedure. I requested pathology be done. The report states candida albicans in both breasts between the implants and capsules. His concern is that this has traveled to my blood. He has put me on diflucan for 5 weeks and requested my rheumatologist refer me to an infectious disease doctor. This request has not been addressed as i am on medicaid. I am concerned i will not get the proper treatment to get well. Candida albicans are very antibiotic resistant and the proper diagnosis by cultures of the blood and antibiotic therapy has to be done the proper way. Link.

8. In october, 1999, i had my plastic surgeon put in mentor saline implants, smooth over the muscle. I had several contractors of the capsule. In about 2003 or thereabouts, i went on disability with an array of problems. Initially, ra, depression, fm ,and was put on drugs that made me worse and i had 3 heat strokes. My health never got better, but i continued with other issues. Changes in thyroid, polyarthritis, rls, rashes, pain and numbness in left arm and right hand, vertigo, loss of balance, dizziness, cognitive dysfunction, fatigue, memory loss, hair loss, deep chest wall pain, nodules in lungs, sleep apnea, adrenal, severe insomnia, anxiety attacks, slow to heal, headaches, back problems, neck pain, joint issues, and more. It was not until i did some research in (b)(6) 2015 that i realized it may be leaking implants. I had surgery with dr. (b)(6), in (b)(6). On (b)(6) 2016. She found mold in my left implant, yeast and bacteria, and my implants were leaking, the valves were defective. I am going on (b)(6) and still disabled. I am getting a little better but i want some compensation for all the missed years of life due to faulty implants. I was not told of all the complications one could have with implants. I was aware of infection and surgical disruption but not that they would leak and cause harm. When i contacted the plastic surgeon, he said they did not have to be removed ever. “don’t fix what ain’t broke” and an “elephant could sit on you and they will not leak or burst”. Link.

9. In 2004, i received a breast augmentation procedure. The implants i had put in were filled with saline. A few years went by with no incident or issue, however this was a short lived bliss. After about the fifth year of having the implants, i began having symptoms of back pain, fatigue, and a burning sensation in my chest wall. Not long after these symptoms started, soon more symptoms began to develop such as: low grade fevers that were accompanied by shooting/burning pains that consumed my entire body. After seeing my general physician for these issues, he diagnosed with fibromyalgia after many evaluations following. This came as a shock to me and all of my family. The medicines used to treat and alleviate fibromyalgia symptoms brought about side effects that were less than desirable medicines as they did not help me whatsoever and only worsened my well being. The three or so years that followed after the fibromyalgia diagnosis were a constant battle of chronic fatigue, low grade fevers, burning/shooting pains, mild depression, and flu like symptoms. In the past year, i have been mostly bed ridden and chronically ill, not able to have a normal functioning life, and dealing with the above stated symptoms that have worsened. All along these many years of dealing with symptoms unk as to why they were occurring, then being thought to have fibromyalgia, divine intervention led me to dig deeper into my existing condition, as i could not and would not accept this health deterioration as what i will face for the rest of my life. To preface this pat about my findings and what followed, i’ll briefly explain how this came about. Here and there throughout these many years, i speculated that the culprit behind my health problems could possibly have been stemming from my breast implants, but after consulting the cosmetic surgeon who performed by breast augmentation, and other various physicians, i was convinced by these practitioners that my breast implants were most definitely not the cause of my health issues. Naturally, it is anyone’s inclination to trust what doctors tell us, and therefore i did just that. Not being able to let go of the pressing thought that my breast implants just might be the root to all of my suffering, i began putting all of my expendable energy into rigorous research regarding breast implant illnesses. It did not take me very long to conclude that my suspicions of my breast implants were indeed the root cause of all of my many years of pain and suffering. I quickly learned about a doctor out of (b)(6) who specializes and advocates in breast implant diseases and breast implant removals. I then started a regular correspondence with this doctor and set an appointment to have my implants removed. Prior to my removal surgery, my blood laboratory results showed the presence of mycoplasma pneumonia. This alarmed me as i learned the nature of this harmful microorganism that invaded by body as a result of tainted implants and a suppressed immunity. It turns out that for years, my body was fighting a silent battle that eventually began showing its face with the onset of my initial symptoms years earlier. All of the years that went by with little to no answers or reputable treatments, the mycoplasma was wreaking havoc within my body and terribly stressing my immune system. When my breast implant removal surgery day came about, my surgeon was not surprised to see that my breast tissues surrounding the implants were badly infected and growing mold and fungus. Five infected lymph nodes were removed that were located near the breast, along with the infected tissues, and of course the implants themselves. My surgeon who performed the removal, also explained that the mycoplasma pneumonia was residing within any and all regions of by body including major internal organs. Link.

10. I have pages of dr appointments that had doctors misdiagnosed me and caused body parts to be removed and killed all in the past two and a half (2. 5) years. Pictures of my mammos catch mold growing for years making me sick and i was never told. I have two doctors and mammo techs willing to speak on my behalf. As a matter of fact they have already written letters for my disability attorney. The mammos speak for themselves, but the photographs of my surgery and explanted implants speak even louder. In midsummer 2013, the pain in my right breast was flaring up again as my left breast grew along with the strange rashes and ill feelings again. This has been going on for approx 4-5 years as documented on my mammo reports. As my newest gp was still trying to get hormones and thyroid regulated from the thyroid ablation 2011 and last ovary removal 2010. My symptoms were not making sense and i was getting worse again even though my blood said the thyroid should be ok; thank goodness doctor (b)(6) goes off how the pt feels and not the blood. As my left breast reached the next cup size and the pain in the right was so bad i had tremors, again, i called to get a mammo, since it had been 2 years due to my almost being in a coma the year before according to dr (b)(6), endocrinologist 2012. The mammo was scheduled for a week to 10 days later on (b)(6) 2013. Friday (b)(6) 2013, as i woke up to do my routine self exam since my mother had breast and ovarian cancers. “ohhhh no! i think i sprung a leak in my right implant. ” my mammo is monday the 30th and all the crazy symptoms come back with a vengeance, lethargic, strangulation feeling times 10, can’t speak and when i do it is super painful with a strange froggy toad sound, the thought of speech puts me in excruciating pain, the strain my body feels, makes a permanent crease in the brow furrow, fingers/toes split open and bleed, the sore on my foot comes back and breaks open, i bruise easily, i look swollen, the lesions on my face return, i am so depressed at how i look and feel, yet i am a positive outgoing person so i put make-up on and pretend i am happy but i feel like dying. I feel and look like a freak, i am ugly. I document my low body temp even though i am sweating as if i have a fever. I take pictures and videos of me taking my temps, the red face, neck, and lesions, i have it all documented. I am diagnosed with biotoxin illness, silicone sensitivity from the silicone shell of the saline implant, the leakage of mold coming from the implant, fibromyalgia, mastodynia in addition to the hashimoto’s thyroiditis and raynaud’s. Dr (b)(6) explains false diagnosis due to the biotoxin disease from the mold. I have pictures and videos of the last 2 years. Link.

11. In 2008, i had smooth saline implants put in, made mentor. Within in several months of having the implant put in, i started experiencing chronic fatigue. I spent months going to different doctors trying to find out why i felt so bad. During that time i was diagnosed with ibs syndrome. My eyes and mouth became very dry. I had to have plugs put into my tear ducts. In 2011, i experienced vertigo. I was unable to function. I was having breast pain in my right breast, i was fatigued. I got to where i could not swallow, i had shortness of breath, anxiety attacks, depression, memory loss and confusion. My feet and hands hurt, i could barely walk. I was told i had chronic fatigue syndrome and fibromyalgia. From (b)(6) 2008 until (b)(6) 2011, i seen around 10 or more doctors with many expensive test done. No one was able to diagnose the cause of my problems, until (b)(6) 2011, when i was told i had biotoxicity illness from my breast implants. At this point i could barely function. I was put on a detox program, to get the fungus and mold out of my body and then on (b)(6) 2011, i had the implants removed. I found out after surgery that i had a (b)(6) infection in my right breast. This had contributed to a lot of my pain and sickness. Two months after surgery i am almost 100% back to my old self. I am outraged that these companies that make breast implants are allowed to keep doing this to women. I read about women everyday that are sick from their implants and no one will help them. I was told i could not file a law suit because the time for that had past. Not only did i almost lose my life because of those toxic bombs, it also put a financial burden on my family. Somebody needs to be held accountable. Dates of use: 3 years; (b)(6) 2008 – (b)(6) 2011. Link.

12. I had mentor smooth saline filled under the muscle breast implants. From the moment they were put in my body, my immune system reacted to everything. My body took twice as long to recover from surgery, childbirth, and everything in between. Over the 12 years i had them in my body. I gradually lost the ability to exercise. I grew up very athletic, so this was like dying. Toward the end of the 12 years, i was not able to be on my feet for long and not able to walk or run, other than grocery shopping and the duties of being a mom. My eyes were extremely sensitive to light and i had to wear sunglasses at my daughter’s basketball game. Inside, i was chronically fatigued for a very long time and the last 4 years i had to take a nap every day to get through life. I had many headaches and so much brain fog that it was difficult to do my job as an actor who is supposed to memorize lines. I survived by using lists in everyday life. I had so much pain that it hurt just to be alive. My body ached on a daily basis. Any time i used any joint, whether it was my wrist on my shoulder, it would hurt for the next 5 days. My feet were constantly sore and i had to replace my arch supports every 30-60 days because it was like walking on bones, my foot doctor said my bottoms of my feet were the thinnest he had ever seen. I had so much tissue and muscle wasting and weight loss. I went from a (b)(6) muscular athletic woman to a (b)(6) frail woman who was malnourished because her body no longer had the ability to absorb nutrients. My gut lining was very damaged from the heavy metals in the lining of the implants. Also, the valves in the implants were faulty and had mold in them when they were removed in (b)(6) 2016. This mold caused me to be very sick. My children were also harmed by the implants while they were in uterus and while breastfeeding. Their immune systems are overreactive to everything. They have many allergies and sensitivities and have similar reactions to things that i have reactions to. Their reactions mimic mine so i know that heavy metals and chemicals have been passed through to them in utero and while breastfeeding i lost a lot of my eyelashes toward the end, and my hair thinned. I had fever and chills a lot toward the end, and night sweats. I had to pee multiple times during the night and always felt thirsty. I lost the ability to digest meat properly, and had to eat mostly fruits, veggies and beans. Life became so difficult at times that i became severely depressed at one point. I lost my hope until i realized that the root of all of my problems started when i got breast implants. As soon as i got them out, a year ago, the color returned to my face and the joint pain mostly disappeared. My brain fog is nearly gone now, and i no longer need daily naps. I am slowly working back into exercising and my eyes are much less sensitive to light. My skin was aging rapidly the last year, and now that the implants are out, the age spots have lightened and i have been complemented on my glowing skin again. I have put on 5 pounds and continue to regain my muscle and athletic ability. I was able to coach my daughter’s basketball team this year for the first time ever. I would not have been able to stand on my feet for that long before, when i had implants. I now have hope for a beautiful future free of pain and full of love with my husband and 3 children. Breast implants stole 12 years of my life and i am so upset that they are allowed to be put in a woman’s body. The destruction they cause is not ok. They should be remove from all surgeries. They are toxic in the human body and they harm babies in utero and while breastfeeding. I will speak with anyone about my experience. I want to share it with the world so no one else has to endure the pain and suffering the implants have caused to me and my family. Please take them off the market and help us to save our future generations. This needs to end. Thank you. Link.

13. Breast implant in (b)(6) 2012, then i started to get around (b)(6) 2013 reoccurring infections, unexplained joint and muscle pain, severe headaches, vision and memory loss, skin issues, multiple er visits, the list goes on. Recently, (b)(6) 2017, breast and nipple pain, feeling of fire, sharp chest pain. On (b)(6) 2017 breast implant removal, due to pain. There is floaties in my saline implants and the valves are brown on inside. Definitely contaminated. Allergan natrelle 68hp saline breast implant. “is the product compounded: yes; did the problem stop after the person reduced the dose or stopped taking or using the product: yes. ” breast augmentation. Link.

14. It was reported that a female patient (age: unk) underwent a breast cosmetic surgery with mentor saline implants in (b)(6) 2001. Recently she had implants explantation for unknown reason. During explantation, the physician observed mold in devices. Link.

15.  It was reported that a female patient received bilateral augmentation mammoplasty in 1998. The patient reported that in mid 2013 she experienced breast pain in the right breast and skin rash and swelling in her right side. These symptoms have been lasting for 4-5 years. The patient reported easy bruising and body swelling. She was diagnosed as biotoxin illness, silicone sensitivity from the silicon shell of the saline implant, mold coming from the implant. According to her physician fibromyalgia, mastodynia, hashimoto¿s thyroiditis and raynaud¿s disease were false positive and her illness was actually due to the biotoxin disease from the mold. Link.

16. It was reported that a female patient underwent bilateral explantation of mentor smooth round high profile saline breast implants. The patient underwent implantation on (b)(6) 2007. Approximately two weeks after the procedure, the patient began to experience a number of symptoms, including extreme anxiety, numbness, tingling, joint pain, brain fog, memory loss, confusion, vision problems, food allergies, difficulty walking, breathing issues, muscle atrophy and hormonal issues. Redness was noted on the left breast, and bilateral pain/burning was experienced approximately 5 years post-procedure. There was no previous history of autoimmune disease. Six months after receiving the implants, the patient underwent a full hysterectomy, as the physicians thought that perhaps her issues were hormonal in nature. Visual contrast sensitivity and human beta growth factor tests were administered. Mold toxicity was suspected, so the patient underwent bilateral explantation on (b)(6) 2015. Capsular contracture and fungal growth were diagnosed in both breasts/implants upon explantation. No extended hospitalization was required. Patient outcome has since improved, with lingering food allergies, gut issues and mold/chemical sensitivity. Link.

17. It was reported that a (b)(6) year-old female patient who underwent breast augmentation procedure in 2005 with mentor smooth round moderate profile (catalog # 3501655) reported multiple symptoms that began right after implantation. The patient reported severe nipple pain, fatigue, joint pain, hair loss, and overall sickness. The patient underwent explantation procedure on (b)(6) 2016. It was reported that the inside of the valve and the outside of the implant had mold. The implants were intact upon explantation. The patient reports that her health is slowly improving but the nipple pain resolved immediately after explantation. Link.

18. It was reported that a female patient who underwent primary breast augmentation with mentor smooth round moderate plus profile saline implants (catalog #3502450, (r) serial #(b)(4), (l) serial #(b)(4)) in (b)(6) 2015 underwent bilateral explantation on (b)(6) 2017. The patient reported that they felt sick for months, and underwent removal due to bilateral mold and valve leaks. The customer requested that no further contact be initiated by mentor for more information. Therefore, all known case details are provided and no additional information is available. Link.

19. It was reported that a (b)(6) year old female patient who underwent breast prostheses implantation in 2009 with mentor saline smooth round moderate plus profile implants 350cc (catalog # 3502350, lot # 5915659) experienced bilateral discomfort and aching. The patient has no history of medical problems. The patient underwent explantation with replacement on (b)(6) 2016 when the surgeon noticed mold in the valve area of both implants :it was described as dark green, brown and black and it was reported that some particles were also in the patient. The surgeon irrigated the cavity and washed it out before inserting new implants. Link.

20. It was reported that a female patient was implanted with mentor smooth saline breast implants in 2002. She stated that her immune system was getting worse since implantation as she experienced autoimmune symptoms. She also reports headaches, brain fog, joint pain, body aches, chronic fatigue, dry eyes, weight loss, digestive system issues, sore feet, and increased recovery period from any surgery. She claimed that the implants were removed in 2016. The implants were found with faulty valves and mold. She also claimed that the implants caused harm to her children during pregnancy and breastfeeding as her children’s immune system were over-reactive to everything. Link.

21. I had implants put in 10 years ago. I immediately became ill with migraines, rheumatoid arthritis, pots, sogrens, lupus and celiac disease. I was disabled for many years. I explanted on (b)(6) 2015 and found the valves to my mentor implants were faulty and created a situation where mold was present. I am doing 95% better and don’t have any signs of 4 out of 5 autoimmune issues. They ruined 10 years of my life and because of my age, i missed having children because i was so sick. Link.

22. Mold chest wall infection from defective implants with leaking valves. Developed mold and debris inside of implants. Toxins poisoned my body. I developed a mold chest wall infection. My muscles became so weak that i am now in a wheelchair. Other issues such as vision problems and constant fatigue. Loss of fine motor skills. Explant (b)(6) 2016. Product defect (leaking valves – mentor saline high profile). Batches of mentor saline implants from 2004 and 2004 had leaking valves. Mold chest wall infection. Toxins leaking out so extensive that it put me in a wheelchair. All of the above on surgical report. Link.

23. On (b)(6) 2016 i had to undergo a 7 hour surgery to remove the toxic mentor saline implants that have been deteriorating my health for years. Capsules were thick, yellowish and my chest full of yellow murk liquid. Right implant was yellow and full of particles inside. Before this surgery, i suffered from insomnia, fatigue, joint pain, back pain, brain fog, hair loss, dry skin, acne, difficulty breathing and others. After surgeon removed the implants, my health has improved by at least 90 percent. It’s clear that the silicone toxins released through the shells were attacking my autoimmune system. Link.

Biotoxin/Mold Tests:

From the tests page:

1. Visual Contrast Sensitivity (VCS) Test – free online (vcstest.com)

2. Lab Work: Alpha MSH, C4a, VEGF, ADH/Osmolality, TGF Beta-1, MMP-9, ACTH/Cortisol, Leptin, VIP, and optionally you can test for specific HLA Drs to check for genetic susceptibility to mold sensitivity. For more information on these tests, see here and here. If you are having gut issues you can do the Candida IgM/IgG test. Additionally, mold can also affect the sinus cavities and you can ask to be tested for MARCONS/staph in the nares.

3. MRI+NeuroQuant test has shown mold toxicity in a lady in the breast implant illness groups. This test can show changes in the brain caused by toxins or PTSD and is excellent for showing inflammation in the brain from mold. To read more about the NeuroQuant test in relation to mold, see here.

4. Other tests: Urine Mycotoxin Tests (mycotoxins are metabolites produced by fungi, such as mold – see here for a study on mycotoxins), Comprehensive Stool Test, and a Mold Sensitivity Panel (Elisa/ACT).

5. If you do test positive for mold, find a naturopathic doctor or functional medicine doctor that specializes in the mold/Dr. Shoemaker protocol. See here for a list of websites that have mold doctor lists. Resources for recovery from mold: survivingmold.com, survivingtoxicmold.com, Dr. Shoemaker 11 Step Treatment Protocol. and biotoxinjourney.com.

Report:

If you have had problems with saline implants and mold, please report them along with all your symptoms to the FDA by submitting an online MedWatch Adverse Reaction Report.

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