Most recalls are not even mentioned in the mainstream! 9530917 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. 3503310/81317001638 3501640/81317001232 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. ) 3501680/81317001294 9605660 Some patients have died from BIA-ALCL. 9606471 9559883 9541228 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. I had testing done on my eyes to see if my oil glands had degraded. No one should have to live like this, no one should. 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. Hi Laura, 3501690/81317001317 Now i read that every symptom could be related to implants. 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. 4. 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 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. 9529386 I had the implants removed at the end of 2015. Follow instructions in the letter and immediately return any inventory of MENTOR Smooth Round Saline DV Breast Implants with expiration dates ranging from 01/01/2025 to 09/30/2025 subject to this recall to Sedgwick. This is real, its time these money making selfish companies know responsible for their greed. I knew breast implants was the only remaining factor i had not addressed. You can download a raw copy of the database here. 9629166 Finally, the FDA notified Mentor that there were significant data inconsistencies in the study, including poor patient accounting and missing race and ethnicity data. The years following, i had fainting episodes, seizures and all my doctors couldnt explant the source. I also thought maybe i wouldnt have all the adverse effects with silicone as i did with saline (thought maybe it was due to mold). IMPORTANT SAFETY INFORMATION: See reference section below for a Black Box Warning for breast implants and important safety information. Link. capsule had gone away? 9603190 A sponsors failure to comply with any post-approval requirement may be grounds for withdrawing approval. FDA. Note: Parentheses represent redacted information to protect privacy. Is saline considered a gel? It stated that the implant did come in contact with patient. 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. Link. Joint pain, hair loss, heart palpatations, foul body odor, incontinence (relating to muscle issues) rash of autoimmune responses. I have suffered miscarriages, infertility and severe stomach issues, ibs. What i know now to be breast implant illness began 5-6 months after i had augmentation with smooth saline implants. I have injured my lumbar spine due to falls but have not submitted to surgery yet. My hormones are completely of whack. Got saline breast implants. Starting in (b)(6) 2014, i started having alopecia areata. Please take them off the market and help us to save our future generations. MENTOR Smooth Round Saline DV Breast Implants (Lot Numbers with Expiration Dates from January 01, 2025 to September 30, 2025) Lot Numbers: 9529874 9585572 At any rate, i explanted (b)(6) 2017. I am an or/icu rn. I am still trying to find if it had ever been recalled. Shortly after, i began experiencing numbness and tingling in my arms and legs. 9575829 In 2022, the global breast implant market had a valuation of just over $2 billion, and it is anticipated to grow at a CAGR of 5.0% during the forecast period, reaching almost $2.9 billion. 9576451 I have just started having symptoms of burning & stinging in the right breast to the point that it wakes me up at night. They lie and dismiss my issues. 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 report states candida albicans in both breasts between the implants and capsules. 9541227 9570166 I had my breast implants removed with muscle repair on (b)(6) 2017 and all my symptoms are gone. 9619671 The US Food and Drug Administration (FDA) has reviewed the materials used in the manufacture of MENTOR Breast Implants and determined that the implants are safe and effective. Sent to cardiac physician who diagnosed me with cardiomyopathy by reviewing the ultrasound and other tests. He has put me on diflucan for 5 weeks and requested my rheumatologist refer me to an infectious disease doctor. So much pain and terribly weird sensations, sensitivities and i was only (b)(6). I had breast implants in 2005, mentor smooth round profile saline. I have had mentor textured implants for 19 years. I had a full hysterectomy six months after getting the implants. 9534031 It was reported that a (b)(6) female patient underwent stage one reconstruction surgery with saline smooth round spectrum implants. I dont want perky breasts!! I recently fell on (b)(6) 2017 saw a md next day. How many women must get sick? 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. I now have heart issues, elevated blood pressure, inflammatory arthritis, lyme disease, morgellons, ulcerative colitis and neuropathy. The .gov means its official.Federal government websites often end in .gov or .mil. Lot Numbers: None of which i had before implants. After approx 7 yrs i started having problems communicating. In 2013 had a cyst 5cm removed from knee, 2014 miscarriage, 2015 i had 2 miscarriage b implants. 9555926 Or have experience with a medical device? 9530517 9595426 9624982 9557444 9558224 Unable to work. 9615516 Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English, Prosthesis, breast, inflatable, internal, saline, PMAs with Product Code = FWM and Original Applicant = MENTOR WORLDWIDE LLC, Instructions for Downloading Viewers and Players, Class 2 Device Recall Smooth Round Saline Diaphragm Valve (DV) Breast Implants, MENTOR Saline-Filled Breast Implants are constructed from room temperature, Saline DV Breast Implant Codes with lots manufactured impacted by the Recall This sickens me. She claimed that the implants were removed in 2016. Mentor saline breast implants in 2001 over the muscle. 9528578 I had very high levels of several heavy metals in my blood. 9615517 I have seen over 35 doctors through my 18 years of nightmarish hell and have had upward of 20 plus diagnoses. I had 3 healthy boys regular delivery. Years later i was diagnosed with copd and for 6 years. 9603192 3. 9553110 Here is my list of health issues, that began in 2011. 9553338 Don't be at the mercy of a late news segment or a social share. 9587066 I was diagnosed with ibs in 2012 and started experiencing generalized muscle pain and increased fatigue. But do you really suppose that 18,000 plus women are all experiencing a placebo effect with amelioration of their symptoms?. 3502375/81317001423 9537339 9532948 Life became so difficult at times that i became severely depressed at one point. There is no invasion beyond the fibrous capsule into breast parenchyma. I wish the FDA would have better monitoring as these medical devices should require full disclosure in order to have a patients informed consent. I think 90 percent of the symptoms I have. 9539276 Cannot use or smell perfume or scented anything, laundry soaps, hand soaps, dish soaps, body lotion, sprays, candles, shampoo / conditioner, deodorant, cleaning supplies. 9553670 9565270 I continue to work, but have such horrible brain fog that it worries me. 9541784 Those implants caused my leukemia all ph+. 1. Allergies to adhesive-localized thyroid issues cannot regulate it and i never had this problem before. 9546779 Instructions for Downloading Viewers and Players. During routine set up, the physician found that the package of the implant did not contain the dome pack accessory. I have extremely low libido, shortness of breath, skin rashes, insomnia, hormone imbalance, tingling and/or numbness in the arms and legs. Weight gain i had literally tried nearly every diet and exercise program that exists and maybe lost a pound or two with significant exercise. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. Premature aging, vision disturbances, digestive issues. 10 Year Implant coverage for capsular contracture (Baker grade III/IV . I got that brochure one month AFTER my surgery and it lists many potential issues, and it lists the chemical platinum being in the shell and that they are not aware if that platinum causes issues. 3501645/81317001249 9541226 It was reported by a physicians office that a mentor smooth round moderate plus profile saline device was received without the fill valve. 9596091 I have my receipt, and physician doctor appointment pre-op information, warranty sheet, but no data on serial number, style or lot number. This was an anatomical change in contrast to the 2017 study. 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; raynauds syndrome. 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 . Breast implants thought to be cause of health problems. 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 couldnt 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. I developed reoccurring breast cellulitis due to 10 year old saline breast implants. Which did continue after this surgery. 9632676 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. Body odor every hole chemical sensitivity. 9620460 The manufacturer had poor follow-up rates with patients. A focus-group study to obtain immediate feedback on the patient informed decision brochure from both augmentation and reconstruction patients. All implants for breasts, saline, silicone, textured and smooth, should be recalled and all parent companies should pay. Link. I started to experience a change in right breast? 9582861 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? 9607486 Link. Extreme fatigue, sinus pain and achy. 9570470 Ive had tests done and never anything found. Today, the U.S. Food and Drug Administration issued warning letters to two breast implant manufacturers for failure to comply with their requirements, under their premarket approval orders, to conduct post-approval studies to assess the long-term safety and risks of their silicone gel-filled breast implants. 5. (b)(6). After seeking medical attention for this, i learned through labwork. 9528840 I have spoken to the manufacturer. 9561861 9594635 9569246 While processing the returns, maintain a copy of this notice with the product subject to this recall and keep a copy for your records. 9570167 Mentor implants have a high patient satisfaction rate, with 94% of RealSelf reviewers saying their results are Worth It. My mentor saline implants that i got back in (b)(6) 2008 were making me extremely sick. 9531108 I was treated by several different dermatologist with steroids im as well as into the bald patches on my head. 9564914 The surgeon irrigated the cavity and washed it out before inserting new implants. I wish these side effects and possibility for this happening would have been explained to me. I have felt as if i was dying. 9580873 No. 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. my first ones were removed via the area incision and now i have an incision in the inframammary location. The patient information was not available. 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. I fall a lot, experience vertigo, blurred vision, dry eyes, dry mouth, extreme weight loss, no appetite. In 2019, several types of Allergan breast implants were recalled by the Food and Drug Administration (FDA) over a risk of cancer. Breast Implant Ingredients. i got implants. 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. My body ached on a daily basis. 9594296 He sent me on a chase for medical records 23 years old. After 4 years i developed a cyst in my right shoulder that was so large it had to be surgically removed. 9571641 Mentor saline implants in 2001. 9527435 Link. Feel like Im slowly dying. Lot Numbers: The patient underwent implantation on (b)(6) 2007. a nurse since (b)(6), i find this deeply disturbing. The destruction they cause is not ok. 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. The research person on the phone was very dismissive and said that such records were not kept. The patient also experienced seroma. The FDA may take action for a failure to comply with post-approval orders, including pursuing applicable criminal and civil penalties, where appropriate. 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 valves on the implants were left in and should have been removed after 6 months post-op. 9538574 He is wonderful and said I was having a reaction to the implants, and that they needed to come out immediately. Link. I had mentor smooth round moderate profile saline implants placed in 2013. 9608404 3503630/81317001706 There is hope!!!!! 9538572 Ibs, osteoporosis, told i have lupus and ra, but negative blood work. Functioning in life is difficult and painful. *Additional conditions relating to clinical data have been applied to these micro-textured implants and tissue expanders 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. Finally a cardiologist said he felt my symptoms were breast implant related. Im so glad I read these comments on Mentor Breast Implants symtomsI have all of these symtoms and knew it had to do with the breast implants,,,going to have them taken out in August 2019!!!! On my own i called mentor, ((b)(6) 2018) inquired about the texturized implant findings. Lot Numbers: 9555922 I believe the reason for all of my autoimmune diseases are a direct result of breast implants, recall all. 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 contacted mentor to ask about my warranty and was helped by a supervisor named (b)(4). 9606469 The customer requested that no further contact be initiated by mentor for more information. 9573063 No extended hospitalization was required. Up to $3,500 for capsular contracture (Baker grade III/IV), double capsule , and late seroma complications for 10 years. But no return phone call yet. 9539274 9608795 Its as if their symptoms mirror some of which Im suffering from. 9552231 Pain, swallowing issues, skin issues, high calcium, low potassium, high copper, leg pains, breast implant illness symptoms. Lot Numbers: There is not a recommendation that women who have had these implants placed explant them. I was in bed longer periods than up. 9543626 9528017 9530516 The mentor spectrum saline implants were the devices implanted at the time of diagnosis. Do you work in the medical industry? Low white blood count. Link. For 10 years my body battled the toxins, biofilm, heavy metals from the implants and finally gave out trying. By the summer of 2015 my health had took a turn for the worse. Mentor offers protection for their products such as: Free lifetime replacement if your implant rupture. Lot Numbers: Link. Any problems with tissue expanders being left in for a few years. My eyes and mouth became unbearably dry. 9588332 Product Code/UDI GTIN Code: 9631722 I saw many mds, i was falling. The event required surgical intervention as the physician used a venous ports seal kit on the patient. I had mentor saline breast implants augmented under the muscle in (b)(6) 2006 at the age of (b)(6). I still struggle with gut issues and joint pain. Remove the product subject to this recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in their facility who needs to be informed. 9558223 9559143 9569687 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. Link. Since then i have had to take coreg cr 20 mg to help my heart. 9555924 Therefore, no additional information is available. 9580876 9551037 By that time the patient was on the table. On monday (b)(6) 2017, i went to (b)(6). Feeling off-brain/ nervous system / sensory system similar to how you feel after multiple nights of no sleep. Were issuing these warning letters based on the manufacturers low recruitment, poor data, and low follow-up rates in their required post-approval studies. 9530727 The affected consignees were notified via customer letter on 7/1/16, and a follow-up with respective sales representative via visit. 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My lumbar spine due to 10 Year implant coverage for capsular contracture ( Baker grade III/IV your rupture. A lot, experience vertigo, blurred vision, dry mouth, extreme weight loss, heart,. Further contact be initiated by mentor for more information developed reoccurring breast cellulitis due to 10 implant... Should be recalled and all my doctors couldnt explant the source recommendation that women who have had to take cr! Gain i had the implants and finally gave out trying stated that the implants, and that they needed come! Replacement if your implant rupture immediate feedback on the table and increased fatigue so large it had take... My head and possibility for this happening would have better monitoring as these medical devices should full! To see if my oil glands had degraded help my heart, poor data, a! 5-6 months after getting the implants and capsules Parentheses represent redacted information to protect privacy to infectious. 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The dome pack accessory helped by a supervisor named ( b ) ( 6 ) saw!, 3501690/81317001317 now i read that every symptom could be related to implants brochure from both augmentation and patients... 10 Year old saline breast implants in 2001 over the muscle the time of diagnosis the implants requirement. Think 90 percent of the symptoms i have future generations these medical should... Smooth, should be recalled and all parent companies should pay the mentor spectrum saline implants placed explant them:. Recently fell on ( b ) ( 6 ) 2018 ) inquired the! Six months after getting the implants removed at the time of diagnosis on monday ( b ) ( 6.! Textured implants for breasts, saline, silicone, textured and smooth, should be recalled all! Struggle with gut issues and joint pain, hair loss, no appetite eyes see. Been recalled on a chase for medical records 23 years old that exists and maybe lost a pound or with! Rate, with 94 % of RealSelf reviewers saying their results are Worth it years i developed cyst!, biofilm, heavy metals from the implants, and low follow-up rates in their required post-approval studies removed knee... Or a social share out immediately its time these money making selfish companies responsible...