Breast Feeding with Implants and Effects on Children
Breast implant surveillance reports to the U.S. Food and Drug Administration: maternal-child health problems (2006). Link.
- We identified 339 reports that described maternal-child adverse events.
- Nearly half of these reports (46%) described actual problems with breastfeeding or expressed concern that implants would be unsafe or interfere with breastfeeding. Forty-four percent of reports (n=149) described either nonspecific or specific signs, symptoms, or illnesses in children. An additional 3.5% of reports (n=12) detailed a congenital anomaly believed by the reporter to be caused by breast implants.
- We studied the Food and Drug Administration (FDA) experience by analyzing a case series of adverse event reports received and entered into the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database or the Device Experience Network (DEN) database by December 31, 2002 regarding women with breast implants. Reports were critically reviewed for lactation difficulties, reproductive problems (spontaneous abortion, delayed conception) and medical conditions among offspring, including neonatal, infant, and childhood diseases and congenital defects that were attributed to implants.
Silicone breast prosthesis and rheumatoid arthritis: a new systemic disease: siliconosis. A case report and a critical review of the literature (1998). Link.
- Breast-feeding by women with silicone implants should not be recommended for possible autoimmune disorders in the children.
Lymphocyte response to silica among offspring of silicone breast implant recipients (1996). Link.
- The current study evaluated immune response to silicon dioxide in children born to women with silicone breast implants. In part one of the study, the T lymphocytes of 21 of 24 such children were significantly stimulated by silicon dioxide (silica). Part two consisted of eleven children, four born preimplantation and seven born postimplantation. None of the preimplant offspring showed T cell responses to silica; five of the seven postimplant children were positive for T cell memory for silica. Part three was a blinded study based on statistically significant differences in T cell stimulation with silicon dioxide between postimplant children and controls.
- These findings indicate a common immune reaction, that of T cell memory, occurs in mothers and their children born after exposure to silicone mammary implants placed prior to pregnancy.
A Case Series Survey of Silicone Breast Implant Patients (1999). Link.
- 90 study participants delivered children after having breast implant surgery. Children were not examined in this study, but documentation was made related to any problems/symptoms elicited from participants.
- The children of these silicone implant patients were ill with learning disorders and chronic infections of the ears or sinuses.
Skin rash and anti-Ro/SS-A antibodies in an infant from a mother with with silicone breast implants (1995). Link.
Autoantibodies and clinical rheumatic complaints in two children of women with silicone gel breast implants (1994). Link.
Sclerodermalike esophageal disease in children breast-fed by mothers with silicone breast implants (1994). Link.
Esphogeal disability in children breast-fed by mothers with silicone breast implants. Long-term follow-up and response to treatment (1996). Link.
Increased urinary No3(-) +N02 and neopterin excretion in children breast fed by mothers with silicone breast implants: evidence of macrophage activation (1996). Link.
Total platinum concentration and platinum oxidation states in body fluids, tissue, and explants from women exposed to silicone and saline breast implants by IC-ICPMS (2006). Link.
Intraductal extension of silicone from a ruptured breast implant (1992). Link.
Health outcomes in offspring of mother with breast implants (2019). Link.
Neuropsychological deficits associated with silicone gel breast implants (1996). Link.
- One area of future research that may help to document the CNS deficits associated with silicone adjuvant disease involves the children of implant patients.
- Some physicians are currently recommending explantation for implant patients contemplating pregnancy, because silicone has been observed in breast milk, and to cross the placental barrier (Lewy, 1994).
Imaging Spectrum of Extracapsular Silicone: Correlation of US, MRI, mammographic, and histopathologic findings (1999). Link.
- Silicone in milk ducts and nipples.
Adjuvant Breast Disease: An evaluation of 100 symptomatic women with breast implants or silicone fluid injections (1994). Link.
- Fig 3 xeromammogram of the breast showing rupture of a silicone-gel breast implant (arrow 1), and free silicone in the milk ducts (arrow 2).
Dr. Pierre Blais: Breast Implants and Breast Feeding
- The very act of inserting such an object in the breast has lasting and irreversible consequences, all of which militate strongly against safe breast feeding. Concurrent physiologic and chemical changes in the breast area impact adversely on the amount and quality of milk produced by lactating mothers where insertion of a foreign object and extensive surgery has been performed.
- The high impurity levels associated with implants, in particular oils similar to what had been used in connection with injected silicone augmentation, where known to impact adversely on lactation.
- Microbiological issues were considered but not given prominence but it was recognized that colonization of the implant site and intracapsular mastitis would be factors that could spread to the lactation apparatus with time.
- Collapse of the lactation system is a logical expectation from surgical damage incidental to implant insertion and gross contamination of the breast by dispersible reactive debris. Similar results are expected from the introduction of implants that exert continuous pressure on the breast gland and the vasculature. Chronic, uncontrollable fibrosis further complicate the situation. Combination of these factors with recurrent low level infective processes will alter the gland over t time and severe discomfort is expected upon engorgement prior to lactation.
- Anatomic, biomechanical and physiologic considerations of the prosthetically modified breast clearly demonstrate why breast feeding is impractical and destructive.
FDA MAUDE – Adverse Reaction Reports – Inclusive of Breast Implants & Effects on Children:
Note: Parentheses represent redacted information to protect privacy.
1. In 1992, i had corporation’s textured saline breast implants. Seven months post-op, i started experiencing double vision and had mri’s with white matter, joint pain, neuro deficits, etc. Although, i did have a previous diagnosis and treatment for lyme’s disease, i was symptom free for several years prior to the implants. I had a medical clearance to get the implants. From there on in my early 20’s, my health went down hill due to chronic illness from the implants, although the company swore they were safe. They never warned me of possible immune system damage otherwise i never would have gotten the. After 13 years of chronic illness, they were removed and the capsules due to a rupture. The same day of my surgery, i had weakness in my left arm and couldn’t write. My left arm is still weak. Theree months later, i had optic neuritis loss of vision in one eye resulting in a now devastating diagnosis of multiple sclerosis. My plastic surgeon told me that these particlular implants, because of the texture, flake off and have caused other pt’s neurological damage and an overactive immune system. To this day, as i almost considered replacement of the implants, these same implants are still available by corp. With all of the illnessess and women out there sick, i contacted corp. Prior to my surgery telling them about my chronic illness as they recommended me replacing then with smooth silicone gel implants as they told me there would be less chance of a rupture resulting in less surgeries that would further compromise my immune system. I find it pretty ignorant that they didn’t tell me a waiver must be signed prior to surgery if i opted to get the silicone gel implants and that other immune disorders could result from the silicone filled implants, lupus, etc. , in which my surgeon told me about. All they want to do is poison women for the sake of their wallets! if the now approved silicone gel filled implants are so “safe” then why do they make a pt sign a release waiver of liability? also, if “silicone is so safe that it is even in our food” then why sign a waver? if saline filled implants are so “safe” in which the shells are made of the same material as the silicone gel filled, why not have women sign a waiver for them so they at least know what the potential health risks can be? i have two young children in which my son has chronic allergies and asthma and my daughter complains of chronic joint pain. I had the implants during both pregnancies. I believe all implants should be illegal as one day it could be someone else’s daughter paying a very high price that is unchangeable for the sake of vanity. The fda should be honest too, with potential pts also and outlaw all breast implants. Link.
2. 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.
3. Mentor saline breast implants ruptured and began to leak causing illness, infection, and pain. There was no accident or impact to cause the implants to leak. My symptoms: fatigue or chronic fatigue cognitive dysfunction (brain fog, difficulty concentrating, memory loss), muscle pain and weakness, joint pain, hair loss, dry skin and hair. Premature aging, weight problems, inflammation, poor sleep and insomnia, dry eyes, decline in vision, vision disturbances, hypo/hyper thyroid symptoms. Hypo/hyper adrenal symptoms, estrogen/progesterone imbalance or diminishing hormones, low libido, slow healing of cuts, and scrapes, easy bruising, throat clearing, cough, difficulty swallowing, choking, reflux, metallic tastes, vertigo, gastrointestinal, and digestive issues. Fevers, night sweats, intolerant to heat/cold, new and persistent bacterial and viral infections, slow clearing of common colds and flus, fungal infections, yeast infections, candida, sinus infections, skin rashes, ear ringing, sudden food intolerance and allergies, headaches, slow muscle recovery after activity, heart palpitations changes in normal heart rate or heart pain, sore and aching joints of shoulders, hips, backbone, hands and feet swollen and tender lymph nodes in breast area. Underarm, throat, neck, groin bouts of dehydration for no reason. Frequent urination, numbness/tingling sensations in upper and lower limbs, cold and discolored limbs, hands and feet, general chest discomfort, shortness of breath, pain and/or burning sensation around implant and/or underarm, liver and kidney dysfunction, cramping, toxic shock symptoms, anxiety, depression and panic attacks, leaky gut, ibs and sibo symptoms of or diagnosis of fibromyalgia, symptoms of or diagnosis of lyme disease, symptoms of or diagnosis of auto-immune diseases such as; raynaud’s syndrome. Hashimoto’s thyroiditis, rheumatoid arthritis, scleroderma, lupus, sjogren’s syndrome, nonspecific connective tissue disease, multiple sclerosis, symptoms of or diagnosis or bia-alcl lymphoma. The implants were 5 y/o when my son was born. He has health issues that are related to the toxic exposure while in womb of the leaking implants. Link.
4. Approx. 5 years after receiving mentor saline siltex textured implants in (b)(6) of 1999, i started to display many symptoms of autoimmune disorders among other strange symptoms. Ultimately, i have been diagnosed with celiac disease, vitiligo, rheumatoid arthritis, hashimoto’s, lyme disease and a liver disorder, among many other accompanying side effects (anxiety, depression, fasciculations, ringing in ears, heart palpitations, memory loss, migraines, hormone deficiency and many others). I have also experienced several miscarriages and became pregnant with one child with a severe birth defect. I ultimately explanted in (b)(6) of 2016. Link.
5. My child was born when i had breast implants and was diagnosed with sensory integration disorders. Pain, swallowing issues, skin issues, high calcium, low potassium, high copper, leg pains, breast implant illness symptoms. Severe gut pains, bone pains, swelling in hands, stiffness in legs. Link.
6. 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.
From the book Chemical Sensitivity: Clinical Manifestations, Volume 3 by Dr. William J. Rhea, pages 1275.:
Burton reported that Gershwin at the University of California at Davis found that some children of patients with implants were also sick. Similarly, at the EHC-Dallas, we have found that 50% of the children of mothers with implants who we have examined have developed food, biological inhalant, and chemical sensitivities.
Immune Response to Silicone (skip to 5:38 for the effects on children)
1. Meredith Kilmer Testimony to FDA on breast implant adverse effects on herself and her children. See March 25th, 2019 Webcast at 6:35:52, below:
My name is Meredith Kilmer from Raleigh, North Carolina and I thank you for your attention.
I had Mentor saline textured implants for 11 years. I am a patient and a caretaker. I implanted in 2001 and explanted in 2012. I never received a booklet or was told they would need to be replaced. I was told they were safe, FDA approved and would out-live me in my grave. I suffered debilitating neurological and systemic symptoms, fibromyalgia, brain fog, fatigue, joint pains, skin rashes – however I have come to tell you about my children.
I have four kids; two born before breast implants and two children conceived while I had breast implants. My children born before breast implants have never had pneumonia, chronic bronchitis, allergies, or morning stiffness. My younger children struggle with the same atypical health problems that I had. When my daughter Paige was born her first antibiotic and antifungal was given at just three weeks of age. She was chronically ill, had numerous pneumonias and skin rashes. Ava is much more symptomatic. By age 3 she had had 13 antibiotics with multiple antifungals, steroids, esophageal issues and is chronically not well. Her quality of life is a struggle. She has fibromyalgia symptoms, chronic neck and fascia stiffness, skin rashes, and she is exhausted most of every day. Both girls have bone and joint pain and their pediatrician state that breast implant illness and its symptoms are not recognized in the medical journals of health disorders. The out of pocket healthcare cost for myself and my daughters are substantial and my children are not the only kids with these symptoms whose mother had breast implants.
In light of this FDA review I reached out to women who have had children while implanted and within the first 24 hours I received 207 written responses from mothers totaling 285 symptomatic children just like my girls. Like me, many of these mothers had non-symptomatic healthy children born before breast implants.
FDA I urge you to consider the five following points to ensure the health and safety of women and their children. We need an alert system to alert pediatricians and a registry run by pediatricians gathering any information on symptomatic children born from mothers with breast implants. The FDA should require an updated study on the amount of cyclic siloxanes and other chemicals found in the breast milk of lactating moms and the breast implant chemicals that are affecting our babies. It is imperative we have a study to determine the safety of breast implant chemicals and its heavy metals crossing through the placental wall and passing through with breast milk. We must have better informed consent to replace the lengthy technical manufacturers’ brochures so the patients can determine if the risks are low enough to implant or not. And we need the medical community and pediatricians to recognize that breast implants can be harmful not only to the mothers but to their precious children in-utero. Thank you.
2. Jennifer Robb Testimony to the FDA on breast implant adverse effects on herself, her grandmother and mother, and her son. See March 26th, 2019 Webcast at 2:16:37, below:
My name is Jennifer Robb, I am a clinician advocate and a third generation of my family harmed by breast implants.
My son, the fourth, his life long battle began in utero. Devin was born 32 weeks. My 4 lb baby boy was placed on a ventilator fighting to survive. Besides respiratory complications, he had food intolerances, failure to thrive, allergies, eye infections, dermatitis, asthma, testing persistent fibrosis. We both spent our lives in and out of hospitals, doctors, and specialists’ office. We’ve become dependent on the government to provide financial and medical assistance. I felt so helpless and frightened. Devin, please stand. Before you is the strongest, most courageous young man I am blessed to call my son. Ladies with BII, cancer, and all mothers with implants please stand.
Today I request, I speak for the unaccounted, children left orphaned, decades of complaints globally, 19 reported deaths from BIA-ALCL, lack of proper testing for those with systemic symptoms now and prior to established guidelines. Also, to remind you of the genetic variants thought to increase the risk of developing autoimmune diseases caused by silicone exposure. For us, the first casualty in our family was my grandmother who died in 1993 after her disintegrated breast implants were removed. My mother’s health wrecked for over 40 years with 3 different brands of breast implants, 3! In 1993, my breasts were augmented, a rupture went undetected for an unknown period of time, never picked up on in imaging. An ultrasound reported floating debris in my implants. The textured shell was severely eroded in adherence to the chest wall making proper removal impossible. Could mesh not do the same? I had symptoms of BIA-ALCL, rashes, lung disease, weight loss, masses, enlarged lymph nodes, brown watery chest, brown watery fluid in my chest and the implant and blood tested positive for a rare fungus. However, the fluid was discarded and specimens never tested appropriately to rule out BIA-ALCL. I was often misdiagnosed, did not return to my plastic surgeon but instead had several life threatening emergencies and hospitalizations including a 3 week stent at Mayo Clinic and Devin finding me unresponsive after being dismissed by an uninformed physician, it was 2 years after surgery. I have pleural effusions, pneumonia, infections, pre-term birth, cardiac arrest, stroke, masses began around the implant at 5 years, my first seroma at eight years, by 25 years old I had the first of many visits with a surgical oncologist for concerning breast issues, and lists of specialists. Familiar with rare, I did not know I had Ehlers-Danlos syndrome, a rare connective tissue disorder or the genetic variants thought to increase the risk of developing cancer or autoimmune diseases caused by silicone exposure.
Please immediately recall textured breast implants, ban the manufacturing, production, distribution, and sale of all breast implants. Demand manufacturer accountability and action. How long does history have to repeat itself. How many lives have to be lost before action takes place. Isn’t one life enough. Banning this lethal product is not to limit choice, I repeat is not to limit choice. Save lives, prevent disease, inspire the creation of new innovative ideas with healthcare options.
Is it not the definition of insanity doing the same thing and expecting different results? Thank you. I urge you to please listen to our pleas.
Additionally, there is available the entire webcast covering both days (25th and 26th) of the March 2019 FDA public meeting reviewing breast implant concerns.
Press Articles & News:
- Catherine Gravitt, et al. v. Mentor Worldwide LLC, a Mentor MemoryGel Silicone Breast Implant lawsuit includes allegations that the plaintiff’s son was born with severe heart defects and daughter with severe bladder and kidney defects, as well as additional physical and mental health problems, allegedly related to the toxic materials leaking from the implants. (2017) See lawsuits and here.
- What is Breast Implant Illness? (2019): For 11 years, Meredith Kilmer was certain her breast implants were the cause of her inability to sleep, shortness of breath, night sweats, weight loss then weight gain, muscle tenderness, and extreme fatigue. She even started to notice some of these same symptoms in her two children that were born after she’d been implanted — both pregnancies had also been almost unbearable, the opposite of her two pregnancies pre-implant.
- Safety of breast implants under review in South Korea after silicone gel founding breast milk (2017)
- Woman whose breast implant went MOLDY while still inside her says the toxic silicone nearly killed her and her breastfeeding baby – after doctors repeatedly failed to diagnose the infection (2015)
- Mother and son almost killed by ‘mouldy’ breast implants (2015)
- Did my faulty [PIP] breast implants kill my darling daughter? As experts warn leaking implants may harm babies, we talk to the mothers terrified they have paid a terrible price for their vanity (2013)
- Doctor links implants to cancer agent found in breast milk (1991)
- Breast implants and birth defects (1992)
- Facebook Support Group: Breast Implants and Children
- SVS, Silicone Breast Implants Organization: Child and Silicone
- Credit to Breast Implants and Children, Medical Case Reports and More for some the studies presented on here.