Mentor Saline-Filled Breast Implants – FDA Information
Scroll down for a list of symptoms women have reported to the FDA and for reports of mold, manufacturer issues, BIA-ALCL, other cancers, body parts removed, and pre and post approval study follow-up.
- Approval Date: May 10th, 2000
- Medical Device Recall Search
- FDA Overview – Saline Breast Implants
- FDA PMA P990075
- Approval Order (Post-Approval Study Conditions)
- Summary of Safety & Effectiveness (Heavy Metals, pg. 6 and bottom of pg. 7 and pg. 8, Adjuvant Effect of Silicone Elastomer, pg. 10)
- Labeling Pamphlet (for physicians, from 2000)
- Labeling Pamphlet #1 (for patients, from 2009)
- Labeling Pamphlet #2 (for physicians, from 2009)
- Supplements: S001, S002, S003, S004, S005, S006,*S007, S008, S009, S010, *S011, *S012, S013, S014, S015, S016, S017, S019, S021,*S022, S023, S024, S025, *S026, S027,*S028, **S029, S030, S031, S032, S033, S034, S035, S036, S037
Mentor Saline Post-Approval Studies:
1. A 10-year post-approval study to assess the long-term clinical performance of the device. All patients enrolled in the premarket Saline Prospective Study (SPS) will be asked to enroll in this post-approval study. Safety data such as reoperations, deflation, capsular contracture, and pain will be collected annually out to 10 years for each patient.
2. Retrieval study to collect visual examination, physical, and histological dat on explanted implants to determine the mode of failure of implants.
3. A focus-group study to obtain immediate feedback on the patient informed decision brochure from both augmentation and reconstruction patients. This will involve obtaining responses from patients on the patient labeling format and content, generating a report of the findings, and incorporating all appropriate revisions immediately.
4. Mechanical testing (i.e., fatigue rupture and shelf-life) to collect additional data.
“Post-approval studies (PAS) are conditions of device approval. A sponsor’s failure to comply with any post-approval requirement may be grounds for withdrawing approval.” – FDA
A search has been done in the FDA post-approval study database for P990075 but no search results appeared. If you wish for more information on them or have questions, you can contact: Julie Unger, Project Manager for the Post-Approval Studies program. Her email is [email protected] and phone number is (301) 796-6134.
FDA MAUDE – Adverse Event Reports for 2017 & 2018 – Mentor Saline Breast Implants:
Note: Parentheses represent redacted information to protect privacy.
Adrenal fatigue, hypothyroidism, hashimotos, back and shoulder pain on left side, lower back pain – left side, heart palpitations. Link.
Chronic fatigue, body pain, brain fog, dry eyes. Link.
Mentor saline breast implants caused hashimotos and sjogrens auto immune. Hair loss, fatigue, brain fog, weight gain. Link.
Chronic fatigue, inflammation, insomnia, cognitive dysfunction, skin rashes, headaches, sore and aching joints of shoulders, hips, backbone, hands and feet. Anxiety, depression, and panic attacks, pain and/or burning sensation around implant and/or underarm, cold and discolored limbs, hands and feet, general chest discomfort. Shortness of breath, frequent urination, numbness/tingling sensations in upper and lower limbs, ear ringing, sudden food intolerance and allergies, vertigo. Link.
This was the month and year i started having heart palpitations, inability to exercise, chronic fatigue, numbness, neck and back pain, frequent fevers, anxiety, lightheadedness, profound muscle weakness, couldn’t recover from anything, feeling like i was literally going to die. Extreme endocrine (blood sugar fluctuations). Inability to sweat. Heat and cold intolerance. Rashes and sensitivities to any lotions, perfumes. Link.
Breast implants thought to be cause of health problems. After having the implants started having problems with angioedema, idiopathic anaphylaxis, edema, hives. Never had problems before implants. Link.
Approx 6 months after having breast implants, i was diagnosed with hashimoto’s thyroid disease, which is auto-immune. I have experienced several problems with my thyroid, heart, severe headaches, etc. I was 100% healthy before the implants. I have no family history of auto-immune disease. I have been in the er at least 5 times due to headaches, heart palpitations, anxiety, etc. I believe this is all due to my saline mentor implants. Link.
I got mentor saline breast implants and right after stated having symptoms resembling ms joint pain, confusion, numbness, brain fog, hormone issues resulting in hysterectomy at (b)(6). One year later, celiac, other food allergies, biotoxin illness, severe symptoms that were debilitating, digestive issues, leaky gut, chemical sensitivity, light and sound sensitivity. Got my implants removed after 8 years in 2015 and 75 percent of the symptoms went away. I still struggle with gut issues and joint pain. I have had years of extensive testing done. Both functional med and regular doc over (b)(6) dollars worth. Link.
I have had mentor textured implants for 19 years. From the moment they were inserted under the muscle i had allergic type reaction. Subsided after 7 months of treatment. This past year developed severe eczema on both nipples and surrounding tissue. Eczema on about 50 percent of my body as well. Explanted (b)(6). By (b)(6). Link.
Received mentor silicone breast implants on (b)(6) 2013. Have had several health issues since. Extreme fatigue, migraines, digestive issues, worsening depression/anxiety, brain fog, memory issues, hair loss, numbness and tingling in left arm and leg, breast pain, chest pain. Explanting asap. Link.
I became very ill, diagnosed with fibromyalgia, capsular contra (grade 3 and 4) many symptoms to include; chronic body pain, breast pain, chronic fatigue, hair loss, muscle, joint weakness and pain, ringing in ears, ibs, insomnia, anxiety, depression, tingling and pins and needles in hands and feet, headaches, weight gain, food intolerances, shoulder, neck, back, arms, hands, leg and foot pain, heart palpitations, shortness of breath, inflammation, diagnosed with fibromyalgia and arthritis, breast tumors and cysts. Shortness of breath, night sweats and hot flashes, nausea, lightheadedness, brain fog, poor concentration. Unable to work. Link.
On (b)(6) 2005, i replaced silicone breast implants (which i discovered had capsular contraction in one and the other was ruptured) with mentor smooth saline implants with the assurance that they were “safe”. I have suffered numerous health problems that i now attributed to the implants: chronic fatigue, cognitive dysfunction, muscle aches, joint pain and soreness, hair loss, dry skin, eyes, mouth, easy bruising and slow healing of wounds. Temperature intolerance even if the house is 77 degrees during the summer, i have sweat clothes on. My hormones are completely of whack. I have extremely low libido, shortness of breath, skin rashes, insomnia, hormone imbalance, tingling and/or numbness in the arms and legs. Pain around the chest wall and breasts, muscle twitching, dehydration, chronic neck and back pain. Premature aging, vision disturbances, digestive issues. Food intolerance and allergies, smell and chemical sensitivities, persistent infections, throat clearing, chronic inflammation, dizziness, mood swings, emotional instability, anxiety and panic attacks. Depression, diagnosed in 1990 with ms 3 years after original silicone implants. Link.
I got mentor saline breast implants. Within 6 months i developed autoimmune disorder; candida cystic acne, unexplained weight gain, cold sores, toe nail fungus, brain fog. Within a year i developed a hernia, then had another hernia the following year. After 4 years i developed a cyst in my right shoulder that was so large it had to be surgically removed. I also developed asthma, and allergies to foods that were never an issue before. Link.
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.
I got textured saline implants over muscle. I was told that these were lifetime devices. These implants unknowingly caused me severe neurological problems, extreme unnatural fatigue, hair loss, developed lipomas, heart palpitations, experience severe burn like pain in arms, neck, under armpit, early menopause, anxiety, loss of dreams and more. I believe the body’s eventual reaction to the implants aged me prematurely. Link.
I got breast implants and they’ve made me very sick. After implants, my hormone levels plummeted (i’ve been to specialist who could not help me) and they were 100% healthy a month before implants. I have widespread pain, heart palpitations, extreme hair loss, rashes, insomnia, chronic fatigue, migraines, edema all over, etc. I was healthy before these implants. I will explant next week to get my life back. Link.
I was actually sick from 2008 – 2015 from mentor saline breast implants. My symptoms started two weeks after getting them. Extreme anxiety, numbness tingling, severe joint pain, brain fog, memory loss, confusion, vision problems, major food allergies, difficulty walking, malabsorption, breathing issues, muscle atrophy, hormonal issues. I had a full hysterectomy six months after getting the implants. Link.
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.
In 2005, i had mentor smooth saline implants placed above the muscle. In (b)(6) 2009, i had a rupture of the left breast implant and (b)(6) 2009 had both replaced with mentor smooth saline moderate profile. Starting in (b)(6) 2014, i started having alopecia areata. I was treated by several different dermatologist with steroids im as well as into the bald patches on my head. There was a stalling hair loss for a period of time, but resumed fall out with complete hair loss by (b)(6) 2014. This included all body hair (underarms, pubic, legs) as well as any head hair. (scalp, eye brows, eye lashes, nasal hair, facial peach fuzz). I have been to a multitude of doctors, none of which have been able to treat the problem. It was bought to my attention by my new functional medicine doctor that i could be having an autoimmune response to the implants. On (b)(6) 2017, i had the mentor implants removed and no implant replacement. Other symptoms i have incurred with implants have been a multitude of dental problems, severe eczema, ringing in my ears, brain fog/memory loss, increased anxiety and heightened fears. I also tested positive for lyme disease. Adrenal fatigue. Link.
Mentor saline implants in 2001. Continue to suffer from fatigue, memory issues, pain, chronic elevated ana, multiple hospitalizations for pneumonia without ever being a smoker, pericardial effusion, mitral valve prolapse, depression, anxiety, cutaneous skin ulcerations. I am desperately trying to get funds together to have them removed. I have been robbed of my ability to practice in the healthcare field, provide my children with a mother whom is both present and available. My life has been ruined! not to mention the numerous times i have attempted suicide. Link.
Got saline breast implants. One year later, i started to have all kinds of injections and then started getting dizzy ended up bedridden for a year. At the age of (b)(6) my vision started to go. Every part of my body was shutting down and no dr. Could tell me why. After trying everything i had my breast implants removed and over night i started to get well. It’s been a year now and i thank god i have another chance at life. They are poison and doing this to so many women. The symptoms seem so unrelated that it’s the last thing you would think of even being as sick as i was. Please help take these off the market and save lives. Link.
Heart problem. Ekg done due to breathing difficulty and swollen ankles. Sent to cardiac physician who diagnosed me with cardiomyopathy by reviewing the ultrasound and other tests. No family history, no alcohol induced cardiomyopathy. Since then i have had to take coreg cr 20 mg to help my heart. And since then i have had a multitude of unexplainable joint aches and pains. I have also had surgeries for those joint problems. Antecubital trigger thumb release, frozen shoulder release, chiropractic manipulation for several back problem etc. Other problems have been, brain fog, sad, allergies consistently, heavy periods at age (b)(6) and had to have cryoablation, cystic breasts with one biopsy (neg) and several aspirations of cysts, and finally the most recent, feeling of helplessness because of all my aching joints. My ana was positive right before explant (b)(6)2017. Link.
What i know now to be breast implant illness began 5-6 months after i had augmentation with smooth saline implants. I was a fit, active, mother of four, very health conscious and began noticing debilitating fatigue and joint pain. As a nurse practitioner and having a physician as a husband we realized immediately that it was likely an autoimmune condition. Testing was done immediately as well as steroid treatment and then other immune modulating drugs. I became very sensitive to many foods, smells, lights, sounds even. I’ve suffered with pain and feeling like i’m honestly not sure that i can get through most days due to fatigue. I continue to work, but have such horrible brain fog that it worries me. I am going to schedule an explant and go through detox in hopes to feel better. I wish these side effects and possibility for this happening would have been explained to me. Not just that, but i hope women can know how severe it can be and how often it is occurring. Rx meds: none, still have implants as date hasn’t been scheduled quite yet for explant. Link.
It was reported that a female patient underwent a breast augmentation with saline mentor breast implants of unknown type and experienced digestive issues, joint problems, lowered immune system, food sensitivities. As a result, the patient had undergone explantation on (b)(6) 2018. Link.
I had breast implants in 2005, mentor smooth round profile saline. In 2013 had a cyst 5cm removed from knee, 2014 – miscarriage, 2015 i had 2 miscarriage b implants. I had 3 healthy boys regular delivery. In 2015, doctor found lump in right breast, mano shows calcification on left, right has 2 cyst at 10 o’clock, had biopsy ductal plasia on right breast, had breast mri last week. I’m scheduled for lumpectomy and also explant. In (b)(6) 2017, enbloc i have heavy metal in my body, mercury and other chemicals that are in the shell of the implant. I also did genetic testing and i am now 4 times fold for celiac, cancer and 90% likely to have breast cancer. Link.
I had a right ruptured mentor breast implant that was removed and replaced on (b)(6) 2002. Ever since that surgery, i had left scapular pain. I had lime green nipple discharge on the right side and blood coming out the left breast nipple. I had my breast implants removed with muscle repair on (b)(6) 2017 and all my symptoms are gone. I had a metal taste in my mouth, tinnitus, chronic pain, chronic fatigue, depression, brittle hair and nails with ridges, +ana test, thyroid levels off and left scapular pain so bad i wanted to overdose and die. It was the breast implant on the left side pulling my chest wall back causing my left scapular to wing out. All these things are completely gone now that these toxic bags are out. They need to be taken off the market. Link.
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.
I had a saline breast implant rupture (b)(6). On (b)(6) i had neck fusion. Woke up systemically ill and in widespread body pain. Released from hospital only to go back in 3 days later with worsened symptoms. I was near death and couldn’t figure out what happened. Bedridden 9 years and on narcotics for pain. Doctors were baffled because lab testing was normal for some time. Then, my ana, c-reactive protein and other tests were elevated. Years later i was diagnosed with copd and for 6 years. It resolved with detoxing and i have residual lung scarring but no asthma or copd. I have seen over 35 doctors through my 18 years of nightmarish hell and have had upward of 20 plus diagnoses. I was on biologic drugs several years without any relief of joint pain or swelling. I now have heart issues, elevated blood pressure, inflammatory arthritis, lyme disease, morgellon’s, ulcerative colitis and neuropathy. Link.
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.
I had saline breast implant in 2005. My sickness started about a year later. I recently explanted in (b)(6) 2016. I had suffered from thyroid disease, autoimmune disorder, hashimoto’s and p. O. T. S. I’ve had to have a full hysterectomy, remove my gallbladder, appendix, and part of my colon out, all by (b)(6). Symptoms: horrific migraines, fatigue, constipation, pain and hardening of one saline implant. Link.
Mentor saline breast implants that i got in 2003. I have several autoimmune diseases and symptoms related to the implants. I believe i have bii (breast implant illness). Link.
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.
I have actually been sick since 2004, but your calendar only goes back to 2007. I have breast implant illness and will be having the implants explanted very soon. I’m trying to pick a doctor now. Link.
Breast implant illness. I had mentor smooth saline with silicon shell breast implants implanted in (b)(6) 1999. I have had numerous disabilities and health issues ever since ranging from thyroid issues, chronic fatigue, cognitive dysfunction, muscle pains and weaknesses. Joint pain, hair loss, heart palpatations, foul body odor, incontinence (relating to muscle issues) rash of autoimmune responses. I’m going in this month for toxins testing. My primary care physician cannot come up with any findings related to my overall health except that the fact my body is being compromised by breast implants that were deemed safe. Link.
I developed reoccurring breast cellulitis due to 10 year old saline breast implants. Link.
On (b)(6) 2004 i had mentor saline implants put in by dr. (b)(6) in (b)(6). I was (b)(6) at the time. Exactly 3 months later i began having pain and swelling in my neck. I was diagnosed with acute thyroiditis. During the next 6 months to 12 months i went through hyperthyroidism and then hypothyroidism. I was diagnosed with graves disease and then eventually hashimoto’s disease. I have been sick with countless sinus infections, gerd, leaky gut syndrome, loss of vision, headaches, vertigo, decreased libido, hormonal imbalance, food allergies, hair loss and breast masses at the last three mammograms. I was never explained of the possible health risks to my immune system and quality of life. I have lost the last 13 years to being sick and have an appointment tomorrow to have another mammogram and ultrasounds to begin testing for bia-alcl. Breast implant illness is a real condition and needs to be explored further and of public health concern. Not only do implants cause immune system cancer as recently released by your administration, but it begins with a snowfall effect of damage to the immune system. Link.
On 2013 began the onset of several health problems that at the time, i had no idea why or what was creating all of the problems. I was healthy, more than healthy. I was an athlete and personal trainer. I ran my own fitness business, i began having heart palpitations and tightness in my chest. Ekg and labs showed no reason. I then began having issues with female health, cysts during ovulation, fibrous dense breast tissue that eventually also led to cysts. Pain, i underwent ultrasounds and blood tests again, no findings. Painful periods and excessive bleeding. Which led to an ablation attempt and eventually ended with hysterectomy last year. Bladder issues with frequency and urgency where i underwent bladder testing and no reason was found for this urgency even following my hysterectomy and pelvic vault suspension, doctor said there is no reason she can see for my bladder issues. Which did continue after this surgery. My eyes and mouth became unbearably dry. I had testing done on my eyes to see if my oil glands had degraded. No. Tear duct plugs were placed, which helped a bit. The addition of prescription eye drops that helped, but my eyes were still red and dry. Blood tests for sjogrens disease, came back negative, due to my dry mouth. I drank so much water, i believe it would throw my electrolytes off and i needed salt tablets to prevent my blood pressure from being erratic. I began to be light headed and eventually full blown vertigo episodes. All of my joints and muscles hurt so bad. I eventually closed my business as i could no longer teach fitness classes. My aerobic capacity diminished and recovery from my own personal workouts was long. I stopped making any strength or cardio goals and also gained about 25 pounds slowly over the following 3-4 years. Brain fog and decreased concentration and memory also took hold. Night sweats to literally being soaked in sweat with a fan blowing on me. Extreme fatigue and the inability to make it through my daily tasks without hours of napping. I was in bed longer periods than up. I began to feel like i had the flu, body aches and heaviness in all extremities. I couldn’t eat anything without instantly bloating. Even healthy fruits and veggies, it didn’t matter. There were moments that i was lying down to sleep and it felt like i was suffocating and would have to consciously direct myself to breathe. It wasn’t until i discovered a website about breast implant illness that i put it all together. I had my explant on (b)(6) 2017 and only one week post op i can tell a huge difference in my dry eyes and mouth. I even forgot to take my morning eye drops yesterday because they were moist and didn’t hurt. Prior to explant, i still immediately took the eye drops just so i could see. Since focusing on nutrition to reduce inflammation, i have lost at least 5 pounds and this is only the beginning to my recovery. I can’t wait for my healing to continue and get my life back. Link.
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. Link.
Insidious health problems increasing in severity over a four year period after breast implant procedure to include; debilitating fatigue, chronic and debilitating joint pain, and cognitive dysfunction. Link.
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?. Link.
I had mentor smooth saline breast implants placed in 1998. Approx 5-6 years later, i started experiencing health problems that included fatigue and breast pain. By 2007, my health issues had progressed with increased fatigue, emotional lability, gastrointestinal problems, and increased breast pain. In 2011, my right implant was encapsulated with severe intermittent pain. I was diagnosed with ibs in 2012 and started experiencing generalized muscle pain and increased fatigue. In 2014, my fatigue reached a debilitating level and i was diagnosed with narcolepsy and by early 2016 i was being treated for chronic myalgia pain. Other generalized symptoms included night sweats, increased emotional lability, nocturia, muscle weakness, loss of strength in my arms and hands, intermittent numbness and tingling in hands and feet, raynaud’s like symptoms in my feet, calcified right breast encapsulation, and progressive joint pain in hands and wrists. All symptoms continued to worsen until surgical removal with total encapsulectomy bilaterally in (b)(6) of 2017. Link.
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.
In 2011 at the age of (b)(6) i had a breast augmentation using mentor 3500cc smooth saline implants. Over the next 6 years i began to experience various symptoms such as daily headaches, insomnia, anxiety, and brain fog that i just wrote off at the time. By the summer of 2015 my health had took a turn for the worse. I became bedridden and only made attempts to get up to see another doctor to just get no answers to my sudden health decline that felt like i was dying some days. Link.
I received my first set of implants in 2005. They were smooth, round, and saline, 270 on one side and 300 on the other. I started having serious difficulty breathing at all times, and especially when laying down at night. I could not get a deep breath. My pcp checked all labs and my heart and lungs and everything was normal. This felt like something physical. I also developed tingling and pain in my hands and itchy pains and a numb right thumb. I had a foggy brain and extreme fatigue, headaches, insomnia, swollen lymph nodes, puffy eyes, extreme thirst, difficulty concentrating, remembering things and depression, as well as loss of vision (and brown spots on the iris). Finally, i developed a goiter and a high cortisol level. I had the implants removed at the end of 2015. Immediately, my breathing was cured! i no longer had shortness of breath. I know it was the implants pushing on my chest, probably due to the capsular contraction. They were hard as a rock from the beginning and extremely uncomfortable throughout and especially toward the end. They were very ripply as well. My breasts were so deformed from the explantation (muscle had attached to the breast tissue and every time i flexed it pulled my breasts inward) that i decided to have new implants put in to see if it would help the deformity and improve my self confidence. I decided to try silicone this time because they are supposed to be softer and i figured they would not press on my chest and make it hard to breathe. I also thought maybe i wouldn’t have all the adverse effects with silicone as i did with saline (thought maybe it was due to mold). Immediately and every day since my surgery 3 weeks ago, i’ve had all of the same symptoms reappeared but even worse. I even developed (b)(6) 3 weeks after the surgery under my armpit, which i’ve never had. I haven’t even had a cold for at least 2 years or more. But since the surgery i feel like my lymph nodes are constantly swollen and keep struggling to fight off infections and colds. I want them removed as soon as possible because i know they are toxic and my body is reacting to them. There should be some kind of warning about the dangers of breast implants. I’ve been reading endless stories online. Implants should be taken off the market, they are so hazardous to our health. I even contacted mentor and the fda via email before and neither seemed to care. So i am reporting my situation. All i want is for my original breasts to look normal and not have the muscle flex deformity. My doctor said there is nothing that can be done to prevent or fix the deformity once the implants are removed. I thought maybe an expander that would be placed between the muscle and tissue to push the muscle back down to the chest wall or maybe stitches to stick the muscle back down so that it’s not pulling the breast tissue when i flex. What is your recommendation? my first ones were removed via the area incision and now i have an incision in the inframammary location. Do you think that made a difference in the muscle deformity? i’m so frustrated and depressed about the last 12 years of feeling horrible and i wish i never decided to get new implants. I feel my breasts are ruined forever now. At this point, though, i really just want to feel healthy again and get these toxic bags out!. Link.
The date above is around the time that i had my mentor saline breast implants put in. After my breast augmentation, i started to get intense neck and shoulder pain along with numbness in my hands and fingers. I went to the hospital a countless amount of times, always leaving with no answers. The only diagnosis i was able to receive was that i had anxiety. Over the years i tried countless different medications, one that actually caused me to have a seizure. I have explanted and i no longer take any psych meds. My blood pressure is no longer high, i have zero neck or shoulder pain, and almost all of my other symptoms have went away. I used to wake up every day in pain, and contemplating suicide many times because i thought i was going to have to live like that the rest of my life. Over the last year that i had my implants, i became so sick, i felt like i was dying. Chest pain, sinus problems, nausea, dizziness, chronic fatigue, muscle aches, pains, and spasms, frequent urination, dry hair, chest deformities with breast pain, hard breasts, one breast that was not ruptured, but looked deflated, skin issues, wobbly feeling when walking, loss of appetite, mental confusion, brain fog, and most likely some other symptoms that i forgot to mention. Almost 95 percent of these symptoms have went away since i have explanted. This is no coincidence, and women are getting more sick every day that passes with breast implant illness. Link.
I had mentor saline breast implants augmented under the muscle in (b)(6) 2006 at the age of (b)(6). In (b)(6) 2014, i had a 2 – week occurrence of vertigo. Shortly after, i began experiencing numbness and tingling in my arms and legs. I was given chiropractic and physical therapy treatments that did not help. I began having severe heart palpitations so i wore a heart halter monitor with no major findings. I began to experience anxiety and panic for unknown reasons so i began increasing my b vitamins, but nothing helped. In (b)(6) 2017, my muscles began to spasm and twitch constantly all over my body. By (b)(6), i began experiencing multiple sclerosis-like symptoms such as cramping muscles, vibrating/ electrical sensations throughout my body, continuing numbness and tingling in my limbs, continual muscle spasms, sore muscles, fibromyalgia, ear ringing, and a constant vibration sensation inside of my head. My vision became blurry, i had difficulty getting a full breath, my anxiety became worse, and i often felt as though i was going to pass out. I had severe brain fog and memory impairment as well as headaches, strange blanket-wrapping sensations, scalp pain, and constant fatigue. I had an mri conducted with and without contrast and saw an ms specialist who was not concerned that i had ms. I also had an emg conducted and saw a separate neurologist within the veteran’s affairs hospital who were also not concerned. I was tested for a multitude of disease such as lyme, eb, anemia, ms, als, etc. All tests came back as normal. In (b)(6) 2017, i learned about breast implant illness or autoimmune syndrome induced by adjuvants. By this time, i had eliminated all caffeine, alcohol, and non-organic cosmetics to lower my overall toxic load. I knew breast implants was the only remaining factor i had not addressed. I had them removed (b)(6) 2017 and have experienced major healing. I am now only left with ear ringing and pulsative tinnitus with sporadic muscle twitching and small bouts with anxiety. Link.
A few years ago i was having hormone inbalance issues. After seeking medical attention for this, i learned through labwork. I had very high levels of several heavy metals in my blood. I underwent treatment for this. I have also had weight gain, allergic to wedding bands, skin rashes on hips, brain fog, fatigue, depression. I was informed that many women are having similar issues that have breast implants. The correlation makes sense to me. I am very healthy, eat healthy, exercise, and live an overall healthy lifestyle. I should not be sick like i am. Labs show inflammation in my body, which is likely due to the implants. I am having the implants removed on (b)(6). Please look at breast implant illness and healing by (b)(6). There is a group of 30,000 women. Many of having symptoms even much worse then i. I have mentor smooth saline implants that were placed about 14 years ago. Link.
I couldn’t pick a date as i have been sick from my mentor saline implants since 2014. And continue to get sick today. I got my implants in 2010. Started showing symptoms in 2012. Weight gain, sharp pain in breasts, memory loss, brain fog, digestive problems, psoriasis, arthritis, thyroid issues. Joint pain, lethargic, slow to heal, sensitive to heat, cold extremities. Inflammation, hoarse voice and throat clearing, hair loss, alcohol intolerance, anxiety, fatigue, muscle pain, insomnia. Difficulty concentrating, muscle weakness, dry skin and hair, headaches daily, migraines, monthly, irritable bowel. Link.
For the past approximately 10 years i have been to doctor for severe fatigue, neck/back pain, bone pain, brain fog, digestive issues, no libido, depression, etc. I’ve had tests done and never anything found. I’ve had multiple lyme tests done that were all negative. One doctor said he felt i may have fibromyalgia and another said maybe the beginning of osteo-arthritis. , i’ve been miserable for years and just don’t know how to feel better. I take vitamins and try to eat healthy. It’s hard to exercise with the fatigue and pain. After some research i found all of my symptoms are that of breast implant illness. I had the mentor saline implants 14 years ago. Now i am researching how to get them properly removed. I am sick over it and sick of feeling sick. Link.
in 2000 i got mentor spectrum adjustable implants; 5 years ago i started getting sick. I’m getting worse. I was healthy prior to 5 years ago, currently show autoimmune symptoms with neg blood work. Hair falling out, weight gain, lymph nodes swollen, breast pain left side. Bruising on body, brain fog, joint muscle chronic pain, body swollen, use walker or cane. Headaches, fevers, fatigue, urinate on myself avg 5 times a day. Ibs, osteoporosis, told i have lupus and ra, but negative blood work. Low white blood count. Depression, asthma, hard time breathing at times. I want to get the implants taken out, but can’t afford to do so. Link.
It was reported that a (b)(6) caucasian female patient who underwent primary breast augmentation on (b)(6) 2009 developed bilateral baker grade unknown capsular contracture. The patient also had low white blood count, positive ana, elevated monocyte level (13%), full body inflammation, massive weight gain, brain fog, tinnitus, major fatigue, memory loss, new onset allergies, skin condition on the knees, rashes, knee/shoulder throbbing, inflamed joints, painful breasts, and hand and “wet” swelling. The patient reported that her blood is “screaming disease and infection. ” the patient underwent testing but everything returned negative for disease. No product issue, such as rupture, was reported. The root cause of the patient’s symptoms are unclear. The patient underwent removal without replacement on (b)(6) 2018. This report is for “the” one of the two implant. Link.
i got implants. Within 3 months started having pain. Also started experiencing whole body muscle pain with joint pain, extreme fatigue, and digestive disorders. Also, i had 2 revisions to discover the implants were on nerves. Years later dr diagnosed me with autoimmune illness, fibromyalgia, sjogren’s syndrome, interstitial cystitis, memory problems, concentration problems, corrective tissue illness and problems finding words when talking. I have become very clumsy, falling often, due to dizziness when i least expect it. I have fallen and injured my cervical spine two times requiring surgery with hardware for stabilization. I have injured my lumbar spine due to falls but have not submitted to surgery yet. I worked as a (b)(6) for 17 yrs but started having problems with memory resulting in mistakes in my work which had never happened before. I could not concentrate. After approx 7 yrs i started having problems communicating. It made me look like someone with brain damage when i would be talking and all of a sudden either couldn’t think of a word i needed to use in a sentence or lose my train of thought completely. I ended up having to leave my job due to these disabilities. Now i read that every symptom could be related to implants. I am currently in the process of trying to have the implants removed but insurance, of course, does not want to pay for explant and all prices were anywhere from (b)(6) to (b)(6). This price does not include mastopexy (breast lift). Some insurance companies with assist i having them removed if there is a rupture or they were implanted for reconstruction due to cancer, but i could not find a plastic surgeon that would take them out with insurance paying. I did research what i could find previous to getting my implants and found no negative reports at that time. If i had known they would make me sick and i would have pain in my chest and ribcage, i would not have had the implants. Ladies need to be made aware this can happen to them so they can make the decision to risk problems. I had no idea. Please help make the mfr put a warning, so ladies will know what they may be dealing with in the future due to breast implant illness. Link.
Mentor saline breast implants in 2001 – over the muscle. Here is my list of health issues, that began in 2011. Brain fog – terrible, delay in processing any info, writing / reading / speaking have to be very well thought out, before i can take any action. Memory – zero memory. Feeling off-brain/ nervous system / sensory system – similar to how you feel after multiple nights of no sleep. Dizziness / light headedness – all the time, irregular heartbeats, daily exhaustion, beyond normal. Blurry vision, visual disturbances, bruising takes months to heal, wounds take months to heal. Eye floaters, hip pan, can barely walk after sitting. Shaky hands, high cholesterol, not a high fat diet. Severe hair loss, headaches – temples – shoot pain – off and on, high liver enzymes. Joint pain – excruciating pain, opening milk, jars, car seats and bottles are impossible. I am (b)(6). Muscle pain, back pain, gingivitis even with excellent oral hygiene. Spine pain (not the same as back pain, more of a tender spine). Fatty liver – ultrasound proven, yellow around the eyes. Body odor – every hole chemical sensitivity. Cannot use or smell perfume or scented anything, laundry soaps, hand soaps, dish soaps, body lotion, sprays, candles, shampoo / conditioner, deodorant, cleaning supplies. Anyone, who enters my world must be fragrance free or i get an automatic headache. I cannot even enter (b)(6). Swollen armpit lymph nodes – daily, mammogram clear. Allergies to adhesive-localized thyroid issues – cannot regulate it and i never had this problem before. Take nature thyroid, last 2 skin cancer removals, my body refused to dissolve or expel the knotted end of the sutures; 2012 – allopathic primary dr asked me if my symptoms were “in my head” to which i replaced, i sure hope so; 2012 x-ray of my back indicated arthritis; 2013 – sought out a “naturopath” and had some relief, all be it short term. Link.
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. Link.
I have been feeling terrible for at least the last ten years or more. I’ve seen drs, had tests, multiple lyme and blood tests, xrays, been to physical therapy but nothing. I have chronic symptoms such as bone pain, neck and back pain, brain fog, severe fatigue that affects my concentration and driving, stomach and digestive issues, and eye problems, etc. Among many symptoms that make me feel like i’m dying a slow death. I have come to learn that these symptoms are all from the mentor saline implants done back in (b)(6) 2004, which i cannot afford to have removed. Functioning in life is difficult and painful. My quality of life is very poor. Link.
I had mentor saline implants for 17 years and had a list of health problems from them. Since explanting, all of my health issues are gone. I was told by my plastic surgeon that they were safe and never warned of the dangers, including that the outer shell is made of silicone with almost 40 toxic chemicals. Link.
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.
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.
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.
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.
It is reported that a patient had both mentor implants sal smooth rnd diap 350cc (catalog#3501655; lot# : 5547192-088) removed due to severe nipple pain, body was rejecting implants. Patient kept implants. Patient had implants in for 10 yrs. Mold was reported in the valve and on the outside of the implant. Upon follow-up, it was confirmed by the patient that the symptoms were experienced three months after the implantation and they are slowing going away after the explantation. Link.
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.
Implanted with mentor textured implants in 1996. In (b)(6) 2018 – routine annual mammo showed the left breast was folding over. This was an anatomical change in contrast to the 2017 study. Therefore, explanted in (b)(6) 2018. Left implant had evidence of blackish fluid within the implant. Lymphoma was ruled out fortunately, ps discussed recent findings of this type of implant and stated that he did not use them. Note: another surgeon in 1996 performed the implantation. On my own i called mentor, ((b)(6) 2018) inquired about the texturized implant findings. I wanted to know how many women had been diagnosed with lymphoma. The research person on the phone was very dismissive and said that such records were not kept. As a pt and an rn, i felt that was not given accountability by mentor due to the findings that came out after my initial implantation. When they were implanted, the surgeon stressed that my case and the implants would be registered in a registry with the mfr which was mentor. Link.
It was reported by a physician’s office that a mentor smooth round moderate profile saline implant (catalog #3501670, serial # (b)(4)) had an out of box issue. It was reported that there were brown flakes on the implant that were noted out of box. Per the customer, the implant did not come into contact with any patient. No patient consequence was reported. The customer requested that no further contact be initiated for follow up attempts. Therefore, no additional information is available. Link.
It was reported that a hair was identified in the package of the implant (saline smooth round high profile implants 310 cc). The follow-up confirmed that the hair was on the implant upon opening a pouch. It was advised that once the issue was identified, the implant was sent to the back. Gloves were changed, and procedure was completed with a new implant. This didn’t add much time to the procedure. There was no patient contact. Link.
It was reported by a physician¿s office that a mentor smooth round moderate plus profile saline device was received without the fill valve. Per the contact, there was no significant procedural delay, and the procedure was completed with a fill valve that the hospital had available. No additional procedure was required, and no adverse event resulted from this incident. Link.
It was reported that fill tube and check valve were missing from box of implant (b)(4) (p/n: 3502350; l/n: 7381657-018). It stated that the implant did come in contact with patient. The patient information was not available. It was further reported that the surgeon used fill tube from secondary implant that was used for contralateral side. The customer kept the product. No additional information has been received to date. If additional information is received, a supplemental 3500a report will be submitted. Link.
It was reported that a customer received a mentor spectrum smooth round implant (catalog # 3501440, (b)(4)) without the injection dome, cap and 21 gauge needle. No patient consequence was reported. They opened another implant for the missing items and procedure was completed. Link.
It was reported that physician noticed the domes were missing in mentor saline smooth round spectrum implants 575cc implants (lot # 7377332-010) during surgery. By that time the patient was on the table. Physician opened another set of implants (lot # 7377332-033) however it was missing domes as well. Additional information was obtained: the procedure was not canceled as the physician continued the procedure. However the delay caused a potential risk to the patient. The event required surgical intervention as the physician used a venous ports seal kit on the patient. Patient was required extended hospitalization. Patient was under general anesthesia for 4 hours (from 7:46am to 12:06pm). The patient is fine now. No other information was available about the patient. Device was sent back to mentor. Link.
It was reported that a (b)(6) female patient underwent stage one reconstruction surgery with saline smooth round spectrum implants. During routine set up, the physician found that the package of the implant did not contain the dome pack accessory. The physician requested for another mentor spectrum package; however, two additional packages also were missing the dome. The physician had to put tissue expanders instead and schedule an additional surgery. This is mdr reportable as an additional procedure was needed to complete a reconstruction surgery. Link.
It was reported by a physician that a (b)(6) caucasian female patient who underwent multiple breast augmentation procedures was diagnosed with bilateral stage ie alcl on (b)(6) 2016. The patient has no known medical comorbidities and no history of breast cancer. The mentor spectrum saline implants were the devices implanted at the time of diagnosis. The patient’s known implant history is the following: the patient had bilateral augmentation in 1992 with unknown implant brand, texture, and fill. The patient then had a revision augmentation in 2002 with textured saline implants (brand unknown). In 2008, the patient has a bilateral revision augmentation due to capsular contracture with unknown implant brand, texture, and fill. The patient then began having problems in left breast (capsular contracture) and underwent revision procedure with unknown implant brand, texture, and fill. The patient then had an infection and underwent explantation without replacement. Four months later, the patient underwent additional revision augmentation with unknown implant brand, texture, and fill. In (b)(6) 2015, the patient began developing capsular contracture in the left breast and in (b)(6) 2015, began developing capsular contracture in the right breast. The patient also experienced seroma. The patient didn’t experience systemic symptoms such as fever, night sweat, or weight loss. On (b)(6) 2016, the patient was diagnosed with bilateral stage ie alcl (cd30 positive, alk negative) via aspiration cytology. The lymphoma cells were found in the effusion fluid surrounding the implant and in the fibrous capsule. There is no invasion beyond the fibrous capsule into breast parenchyma. The patient underwent bilateral explantation with total capsulectomies and no replacement implants in (b)(6) 2016. The patient did not receive chemotherapy or radiation therapy. As of (b)(6) 2016, the patient is alive and has no evidence of alcl. Link.
It was reported that the patient was diagnosed with bia alcl after using mentor saline implants. No patient contact information was provided. Hence, follow ups for further investigation could not be performed. Link.
This is event was reported via # mw5023558. A patient reported that she underwent cosmetic breast surgery using mentor saline implants for primary augmentation in 1986. In 2008 she was diagnosed with anaplastic large cell lymphoma. The patient was treated with chemotherapy and radiation therapy. Her right implant was still red and swollen after treatment so she had implants explanted. No contact information was provided in mw report, therefore no further information has been made available. Link.
I put in breast implants, told dr i immediately felt pain, neurological problems, severe unintentional weight loss, fatigue, wanted them out but the plastic surgeon said there was nothing wrong with me, that i was a slow healer, that my implants looked great and he wasn’t going to remove them. I spent years and probably thousands of dollars going to drs for testing, after testing and every dr said it was absolutely not my implants. My breast were hard as rocks. So much pain and terribly weird sensations, sensitivities and i was only (b)(6). Was told by so many drs that i needed depression medicine. They felt i was depressed with four kids. Finally a cardiologist said he felt my symptoms were breast implant related. I explanted a few months later and within a month i had cancer. Was given two weeks to live if no treatment. Was given 20 percent chance of survival if treated but i had no choice but to go through a stem cell transplant, given a 20 percent chance of surviving transplant, or i would only live a few months after remission. I suffered and survived only because i removed my implants. Those implants caused my leukemia all ph+. For 10 years my body battled the toxins, biofilm, heavy metals from the implants and finally gave out trying.
I actually started feeling ill within a year of my implants. I have been diagnosed with fibromyalgia, uterine cancer, ovarian cancer, chronic fatigue, food allergies, joint pain etc. None of which i had before implants. Link.
Body Parts Removed:
My gallbladder had to be removed, due to it working only at 11% after nuclear testing. Severe pain in breasts started in 2016 along with drastic weight loss. An explant surgery on (b)(6) 2017, left was leaking and partially deflated. Right had capsular contracture. Link.
I had saline breast implants in 2007. I’ve had symptoms of depression, anxiety, fatigue, hair loss, back and neck pain, pain in my breast, joint pain, numbness in my hands and arms, swallowing problems with chocking, unk rashes, and hormone imbalance caused hysterectomy (b)(6) 2016. Link.
Pre and Post Approval Studies:
1. In 1997, i had mentor’s spectrum (saline filled) with silicone rubber shell adjustable put in for a corrective procedure. I was never explained that i was to be in clinical trials. I was told by my surgeon that since silicone was banned that i would need special approval to get these implants. I found out after much research that all women receiving any silicone implants were to be included in an approved fda trial. I was a part of the (b)(6). Mentor and their irb did not do any f/u with me although i worked on the same street as mentor and i did further charity work with the surgeon through my companies devices we donated. Never was i contacted for any f/u. My surgeon passed suddenly in 2003. In 2002 i began having health problems. Skin rashes, heart palpitations. I was diagnosed with supra ventricular tachycardia and placed on medication. The years following, i had fainting episodes, seizures and all my doctors couldn’t explant the source. I was diagnosed in 2006 with sle (lupus). I had hyperthyroidism, hypothyroidism, hair loss raynaud’s disease. Skin wound healing problems, bleeding disorder called von willebrand’s and severe allergic reactions, which caused me to be on life support and no other cause. I have mental fog, inability to regulate my body heat, poor skin coloration from bad circulation. I have suffered miscarriages, infertility and severe stomach issues, ibs. I have seen many doctors during these last years and no one ever could find a source. They all said it was most likely lupus and left it at that. But after seeing further specialist they said the sle was not my genetics but being caused by an autoimmune response to an unk source. With joint pain, numbness in feet and hands. Blurred vision and overall exhaustion. I have felt as if i was dying. My left implant ruptured 2 weeks ago. I contacted mentor to ask about my warranty and was helped by a supervisor named (b)(4). He was able to locate me by my name and dob, locating my implants and told me to find a surgeon and they would send his replacement implants. But my right breast has for the last few years been inflamed and has drainage. It is hard and painful. The valves on the implants were left in and should have been removed after 6 months post-op. I also located documents for mentors pma of device p990075 and were they used the studies from (b)(6) to gain approval for their pma. The fda allowed their pma with the conditions to add the (b)(6) into the post-approval study which was a 10 year f/u mentor stated to the fda that they attempted to contact and mail enrollment packets to these women but couldn’t locate the majority despite the data base they had and was part of the fda rules to save each device and the person receiving them. The fda under the rules of conditions for approval, made mentor do a more aggressive search using the 411 databases. (b)(6) address change datasheet with (b)(6). I was never contacted and i was more than easy to find. I hadn’t changed my address in years. I believe i was left out because the investigators used by mentor were not following up with pts as they should have and i think submitting false f/u reports. Now i contacted mentor a few days ago to speak with mr. (b)(4), as i had previously asked who would help me cover the new surgeons expenses, only to find mr (b)(4) was unavailable and the new supervisor couldn’t locate me like mr. (b)(4) had been able to. Mr. (b)(4) had requested me to write an email, stating my health issues, and the need for help to get the ruptured implant out and because i was “unique out of the box situation” he would be forwarding it to mentor legals department to see what they are willing to do. Now i see it because i was part of these studies and not f/u with. I believe these implants have made me gravely ill and mentor is blocking me in receiving proper treatment. Link.