I never equated my undiagnosable non-stop immune issues, GI issues, constant tissue nasal infections, fatigue, vision blurry, hair loss, osteopenia, all over the past 5 years. His name is Dr. Bradford Roberg in Crystal Lake, IL. Approx. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company. 9582184 Fatty liver ultrasound proven, yellow around the eyes. Blood tests for sjogrens disease, came back negative, due to my dry mouth. 9558851 I have all the same symptoms and after finding a site for women in the Northwest with the same problems I am taking them out. Note: Parentheses represent redacted information to protect privacy. FDA Documents: Approval Date: November 17th, 2006 Recalls FDA Overview - Mentor MemoryGel [] I have a weak immune system, i get cold sores now, recently had an anaphylactic reaction, the list is endless. 9596397 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. 9552231 9576454 A sponsors failure to comply with any post-approval requirement may be grounds for withdrawing approval. FDA. 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 couldnt locate me like mr. (b)(4) had been able to. Breast implant illness is a real condition and needs to be explored further and of public health concern. 9616933 This request has not been addressed as i am on medicaid. I have been diagnosed with panic attacks, multiple sclerosis, r/a, fibromyalgia, chronic fatigue syndrome, raynauds disease, thoracic outlet syndrome, chronic insomnia. I still struggle with gut issues and joint pain. 9541786 I had them removed (b)(6) 2017 and have experienced major healing. 9583026 9547975 It was advised that once the issue was identified, the implant was sent to the back. 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. Mentor Worldwide LLC) passed preemption in part(s) and are proceeding to jury trial. 9555185 9538574 9617819 Ive struggled with constant fatigue, joint pain, headaches, hives- almost every day, chest pain, hormonal issues etc. Saline DV Breast Implant Codes without lots manufactured impacted by the Recall If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. I scheduled an explant for 12/02/20. Explanted (b)(6). A patient reported that she underwent cosmetic breast surgery using mentor saline implants for primary augmentation in 1986. MENTOR Smooth Round Saline DV Implant 350-3190/00081317001577. I have had these implants for 6 years (smooth round high profile gel) I have literally been sick with a lot of these symptoms since a month after having them put in..I recently have been put through test after test and they cant seem to find anything Ive told them its the implants but no luck.Finally a plastic surgeon agreed to remove them on dec.19th .thank you I will continue to follow this page .. Cassandra , have u improved since ur implants was removed? I met with two surgeons which confirmed breast implant illness for me and i then scheduled my surgery for (b)(6) 2018. 9541225 Its clear that the silicone toxins released through the shells were attacking my autoimmune system. They need to be taken off the market. Ive had chronic infections since these were placed. Depression, diagnosed in 1990 with ms 3 years after original silicone implants. 9558222 9567249 It has been 1.5 years. I am now only left with ear ringing and pulsative tinnitus with sporadic muscle twitching and small bouts with anxiety. Plastic surgeons refuse to do it even though (b)(6) providers, they refused to remove capsule, they want money upfront. 9561195 9614477 9547972 Researching now to have my implants removed. I had no idea. 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. 9595426 Over the years i tried countless different medications, one that actually caused me to have a seizure. 9554349 Severe gut pains, bone pains, swelling in hands, stiffness in legs. My card states Smooth Round High Profile Gel. 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. I became very sensitive to many foods, smells, lights, sounds even. Lot Numbers: I am very healthy, eat healthy, exercise, and live an overall healthy lifestyle. I was a health woman before I put them in and wish I never had. 9540919 With joint pain, numbness in feet and hands. Federal health officials have determined that a second silicone breast implant recall does not need to be issued due to the potential safety concerns that have surfaced recently.. FDA officials . I hope your explant was successful. It was reported that a (b)(6) female patient underwent stage one reconstruction surgery with saline smooth round spectrum implants. Link. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements. I have had mentor textured implants for 19 years. I am 72 y.o. I am (b)(6). Lot Number: The implants were 5 y/o when my son was born. Any non-affected product and any product returned after the dat. 9557445 I am desperately trying to get funds together to have them removed. 9576970 9614987 Doesnt matter I want to feel healthy . Blurry vision, visual disturbances, bruising takes months to heal, wounds take months to heal. 9570168 I was getting pneumonia 10 times a year, could not work as much, suffered cognitive difficulties interfering with a high tech job. 9540918 The lawsuit claims Mentor has known about the health problems linked to silicone breast implants for years, yet failed to warn the medical community or patients, actively concealing the risks. I started to experience a change in right breast? Link. 9592326 9610034 I had saline breast implants in 2007. As soon as i got them out, a year ago, the color returned to my face and the joint pain mostly disappeared. 9563942 I cant wait for my healing to continue and get my life back. 9530916 I was healthy, more than healthy. 9536099 9590027 (scalp, eye brows, eye lashes, nasal hair, facial peach fuzz). We want to hear from you. The list below outlines the current status of breast implant devices and will be updated as needed. I should not be sick like i am. 9525967 Your complete guide to recalls, "breast implant illness," and the conversation surrounding them. Not to mention people thinking you are imagining all of this. This felt like something physical. The patient is fine now. This newly launched registry will greatly add to the information we collect in our own post-approval studies about the long-term safety of breast implants, and potentially enhance our understanding of the long term safety and risks associated with breast implants. Severe pain in breasts started in 2016 along with drastic weight loss. 9547973 I explanted a few months later and within a month i had cancer. In 2013 had a cyst 5cm removed from knee, 2014 miscarriage, 2015 i had 2 miscarriage b implants. The manufacturer had poor follow-up rates with patients. 9533290 9591673 9578063 9554350 9543991 Some days I feel like I am laterally dying! 9614773 The implants were intact upon explantation. Note: another surgeon in 1996 performed the implantation. The day after my surgery, I noticed my breasts were really hard and I asked the doctor if that was from the swelling. During routine set up, the physician found that the package of the implant did not contain the dome pack accessory. 9528016 9535775 The FDAs warning letter to Mentor Worldwide LLC (Mentor) noted several serious deficiencies in the manufacturers post-approval study for its MemoryShape breast implant, first approved in 2013, including that the manufacturer had failed to enroll the required number of patients in the study. Within 6 months i developed autoimmune disorder; candida cystic acne, unexplained weight gain, cold sores, toe nail fungus, brain fog. Lot Numbers: 9533838 9533840 July 29, 2019. how many of us must suffer because we do not have money to pay to have them removed? 9555187 Got saline breast implants. Link. Ekg and labs showed no reason. 3501635/81317001225 Link. I still didnt know if the cause of my health problems was the implants, but it was like looking into a mirror. (A black and white photo copied paper) I live in Texas now, decided to call my PS from IL., only to discover he closed his office in 2008 after a narcotics, fraud charge. I have mental fog, inability to regulate my body heat, poor skin coloration from bad circulation. I got breast implants and theyve made me very sick. 9585572 If you are having symptoms, get your implants out NOW and save your life. Tear duct plugs were placed, which helped a bit. I made several call backs, no assistance. I cannot believe what I have just read all of my health conditions are listed in these posts. 9571294 Lost his license for 3 years, hes practicing again. 9614774 Within a year i developed a hernia, then had another hernia the following year. Link. My symptoms started two weeks after getting them. I am two weeks out from surgery and i am healing every day. Please see the Explant Surgeons page for the explant experts as well as for a list of explant surgeons by country and state who have been recommended by women. Inability to sweat. 9569689 Heart problem. 9617814 I have actually been sick since 2004, but your calendar only goes back to 2007. Right implant was yellow and full of particles inside. 9629493 9576683 9608402 9542800 9555184 Link. 9594633 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. But do you really suppose that 18,000 plus women are all experiencing a placebo effect with amelioration of their symptoms?. Among many symptoms that make me feel like im dying a slow death. No contact information was provided in mw report, therefore no further information has been made available. Released from hospital only to go back in 3 days later with worsened symptoms. Link. These incidences spontaneously resolved. Link. Life became so difficult at times that i became severely depressed at one point. 9559142 The addition of prescription eye drops that helped, but my eyes were still red and dry. Link. 9578064 The FDA has issued several warning letters in recent years to manufacturers who did not adequately fulfill certain postmarket study requirements, reflecting the agencys commitment to take more aggressive actions against manufacturers who fail to comply. 9543627 Patient kept implants. 9573298 9608403 Mentor saline breast implants that i got in 2003. Ibs, osteoporosis, told i have lupus and ra, but negative blood work. Every manufacturer of approved silicone gel-filled breast implants is required to conduct post-approval studies to further evaluate safety and effectiveness of the products and to answer additional scientific questions about the long-term safety and potential risks of breast implants that their premarket clinical trials were not designed to answer. As the months continued i still suffered from extreme fatigue, joint and muscle pain, and sinus issues. Both functional med and regular doc over (b)(6) dollars worth. I am an or/icu rn. I suppose that its only an anecdotal report and that correlation does not equal causation; and perhaps my symptoms were not due to breast implants, since i cant prove it. However, in October 2021, Mentor initiated a voluntary recall of its smooth, round saline diaphragm valve breast implants with expiration dates from January 01, 2025 to September 30, 2025. On (b)(6) i had neck fusion. Gloves were changed, and procedure was completed with a new implant. I was healthy prior to 5 years ago, currently show autoimmune symptoms with neg blood work. I ended up having to leave my job due to these disabilities. No relief after surgery. 9559518 9541787 Lot Numbers: Link. 9615517 9620460 those that do are lucky. 9626607 My body took twice as long to recover from surgery, childbirth, and everything in between. Also, the valves in the implants were faulty and had mold in them when they were removed in (b)(6) 2016. My child was born when i had breast implants and was diagnosed with sensory integration disorders. 9564914 9559882 9595425 9579267 Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. I had severe stinging in my hands and feet and an absolutely awful chemical taste in my mouth. 9549488 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. They are getting better? Implants should be taken off the market, they are so hazardous to our health. 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. The patient didnt experience systemic symptoms such as fever, night sweat, or weight loss. 3503270/81317001614 9608794 9555927 Link. I am an rn, i returned to work following year 1999. During the next 6 months to 12 months i went through hyperthyroidism and then hypothyroidism. i no longer had shortness of breath. After seeking medical attention for this, i learned through labwork. Was given two weeks to live if no treatment. As a result of this issue, these implants may prematurely deflate for which replacement surgery may be needed. 9556605 I dont want perky breasts!! 9570471 The FDA welcomes public dialogue about breast implant safety and risk at the upcoming public meeting of the General and Plastic Surgery Devices Panel at the FDAs headquarters in Silver Spring, Maryland on March 25-26, 2019, which will also be available via webcast. I was never explained of the possible health risks to my immune system and quality of life. In 2008 she was diagnosed with anaplastic large cell lymphoma. MENTOR Smooth Round Saline DV Implant 350-1615/00081317001188 The patient has no known medical comorbidities and no history of breast cancer. (b)(6). Up to $3,500. Mentor Texas, LP., 3025 Skyway Cir N, Irving TX 75038-3524, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147917, Device Recall Mentor MemoryGel Breast Implant, International Consortium of Investigative Journalists. I had mentor smooth saline with silicon shell breast implants implanted in (b)(6) 1999. 2. All i want is for my original breasts to look normal and not have the muscle flex deformity. Same here. Link. I also developed tingling and pain in my hands and itchy pains and a numb right thumb. I have seen over 35 doctors through my 18 years of nightmarish hell and have had upward of 20 plus diagnoses. The root cause of the patients symptoms are unclear. I cant wait to get these things out if me, maybe then I will feel human instead if s cow with a fifty pound weight gain, pain all over my body , even the bottom if my feet burn. Ive had tests done and never anything found. Joint pain, hair loss, heart palpatations, foul body odor, incontinence (relating to muscle issues) rash of autoimmune responses. But since the surgery i feel like my lymph nodes are constantly swollen and keep struggling to fight off infections and colds. 9546176 I went on a (b)(6) breast explant group to solicit recommendations for explant surgeons. Blurred vision and overall exhaustion. I have debilitating days. 9594634 I had severe brain fog and memory impairment as well as headaches, strange blanket-wrapping sensations, scalp pain, and constant fatigue. Pain around the chest wall and breasts, muscle twitching, dehydration, chronic neck and back pain. Ive been in many MVC & shrugged it off as that is what led to my disabilities. Link. I broke my foot, balance off, and felt horrible. 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. 9602765 Lot Numbers: 9614989 9534030 I have no family history of auto-immune disease. 9555186 Link. I was never contacted and i was more than easy to find. My mentor saline implants that i got back in (b)(6) 2008 were making me extremely sick. Please help me get all of this out. 9610033 9550164 Mentor saline breast implants caused hashimotos and sjogrens auto immune. However the delay caused a potential risk to the patient. Lot Numbers: 9530727 9541783 3503210/81317001584 9630358 9546471 9570169 9530519 I suffered and survived only because i removed my implants. MENTOR Saline-Filled Breast Implants are inflated to the desired size with sterile isotonic saline before implantation, as well as postimplantation. Body odor every hole chemical sensitivity. 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. Lot Numbers: I have been to a multitude of doctors, none of which have been able to treat the problem. Link. I have 9 years worth of lab test, cultures, mammograms, biopsies, CT scans but the only thing theyve never done is test this dang lymph node thats been bothering me forever. In addition to the required post-approval studies, the FDA has taken additional steps to ensure the agency is monitoring the safety and risks of breast implants. 9558225 3502600/81317001492 Don't be at the mercy of a late news segment or a social share. This cancer occurs more commonly in patients with textured breast implants than smooth Implants, although rates are not well defined. 9588333 I could not get a deep breath. I eventually closed my business as i could no longer teach fitness classes. I am sick over it and sick of feeling sick. 9596092 I grew up very athletic, so this was like dying. 9616497 I will tell my story, and would never recommend breast implants to anyone. Ref 350-7504BC. 9538080 No other information was available about the patient. I ended up going to a gastroenterologist and was diagnosed with ibs. Depression, asthma, hard time breathing at times. 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. 9574860 Link. 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 reported that the patient was diagnosed with bia alcl after using mentor saline implants. I am scheduled for an explant June 2022. 9569247 Always cite the International Consortium of Investigative Journalists when using this data. God Bless everyone, its nice to know Im not crazy! Mentor Saline implants in 1998. Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. 9575830 The patients known implant history is the following: the patient had bilateral augmentation in 1992 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. 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