3501630/81317001218 9584310 9550675 Product Code/UDI GTIN Code: 9550672 i got implants. Something needs to be done about this!!!! One doctor said he felt i may have fibromyalgia and another said maybe the beginning of osteo-arthritis. 9563943 In 2011 at the age of (b)(6) i had a breast augmentation using mentor 3500cc smooth saline implants. 9563941 Copyright 2016-2022 BreastImplantIllness.com. Link. 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. My implants were put in in 2008 and were Mentor Saline Implants. Bruising on body, brain fog, joint muscle chronic pain, body swollen, use walker or cane. Mentor Siltex breast implants and anaplastic large cell lymphoma 27 March 2020 Johnson & Johnson Medical New Zealand Ltd is notifying surgeons that these devices carry a risk of breast implant associated-anaplastic large cell lymphoma (BIA-ALCL). They all said it was most likely lupus and left it at that. The FDA issued warning letters to Mentor Worldwide LLC of Irvine, California, and Sientra, Inc. of Santa Barbara, California. 9546472 On (b)(6) i had neck fusion. This is mdr reportable as an additional procedure was needed to complete a reconstruction surgery. By this time, i had eliminated all caffeine, alcohol, and non-organic cosmetics to lower my overall toxic load. 9555184 9570471 Currently, the manufacturer reported a follow-up rate of 61 percent, which is below the target follow-up rate. 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. 9582573 Antecubital trigger thumb release, frozen shoulder release, chiropractic manipulation for several back problem etc. 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. Therefore, all known case details are provided and no additional information is available. 3503210/81317001584 9533292 I am concerned i will not get the proper treatment to get well. Lot Numbers: Explanted (b)(6). Link. 9566958 3503310/81317001638 9622909 9542801 9570470 I had 3 healthy boys regular delivery. Ive had mentor saline smooth round high profile implants since 2015. 3501645/81317001249 9538081 Link. 9580414 I broke my foot, balance off, and felt horrible. The patient then had a revision augmentation in 2002 with textured saline implants (brand unknown). Device was sent back to mentor. I had a saline breast implant rupture (b)(6). On (b)(6) 2017 he is a (b)(6) provider and had spoken to me prior. Up to $3,500. 9550486 I am an or/icu rn. I recently fell on (b)(6) 2017 saw a md next day. By sunday (b)(6) left implant was deflated, there was bruising of breasts from traumatic fall. Painful periods and excessive bleeding. Mentor Worldwide LLC) passed preemption in part(s) and are proceeding to jury trial. July 29, 2019. 9568916 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. 9602765 I was diagnosed with ibs in 2012 and started experiencing generalized muscle pain and increased fatigue. 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. 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. 9629494 I guess its best to contact my plastic surgeon? 9608403 I have my receipt, and physician doctor appointment pre-op information, warranty sheet, but no data on serial number, style or lot number. I was never contacted and i was more than easy to find. He is wonderful and said I was having a reaction to the implants, and that they needed to come out immediately. 9528580 Ive suffered with pain and feeling like im honestly not sure that i can get through most days due to fatigue. 9603192 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. 3502300/81317001393 Trying to figure out what to do. I have chronic joint pain, fatigue, anxiety, migraines, hair loss, and many other issues. 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. Testing was done immediately as well as steroid treatment and then other immune modulating drugs. 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. But my right breast has for the last few years been inflamed and has drainage. A search has been done in the FDA post-approval study database for P990075 but no search results appeared. 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). 9570166 I got my implants in 2010. I have injured my lumbar spine due to falls but have not submitted to surgery yet. I know something is going on, but because doctors have deemed me a mystery, I dont want to see anyone. 9610033 9528841 I have a lot of these symptoms. By 2004 i found it impossible to work at all, i was only (b)(6). I was a part of the (b)(6). 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. 9549491 I found a new surgeon and had them taken out immediately. 9565270 9546780 9611045 9553669 9558852 My blood pressure is no longer high, i have zero neck or shoulder pain, and almost all of my other symptoms have went away. This case is still ongoing as of November 2019. Symptoms: horrific migraines, fatigue, constipation, pain and hardening of one saline implant. Link. During the next 6 months to 12 months i went through hyperthyroidism and then hypothyroidism. 9614989 Link. 9592612 9537340 9610034 On (b)(6) 2017, i had the mentor implants removed and no implant replacement. He said no, it was because he used the textured mentor breast implants (they are in the shape of a tear drop) as he thought they looked better than the smooth ones. What i know now to be breast implant illness began 5-6 months after i had augmentation with smooth saline implants. Rx meds: none, still have implants as date hasnt been scheduled quite yet for explant. I look 45 years old. 3502475/81317001461 Medical Device Recall of MENTOR Smooth Round Saline DV Breast Implants Page 1 of 6 Event #7209. Link. 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. The FDAs warning letter to Sientra, Inc. (Sientra) noted a serious deficiency in the manufacturers post-approval study for its Silicone Gel Breast Implants, first approved in 2013. Years later i was diagnosed with copd and for 6 years. I have explanted and i no longer take any psych meds. 9597741 No patient consequence was reported. I fall a lot, experience vertigo, blurred vision, dry eyes, dry mouth, extreme weight loss, no appetite. But do you really suppose that 18,000 plus women are all experiencing a placebo effect with amelioration of their symptoms?. 9532946 The list below outlines the current status of breast implant devices and will be updated as needed. 9563942 It stated that the implant did come in contact with patient. My eyes and mouth became unbearably dry. The FDA requested the voluntary recall from Allergan after a "significant increase" in cases of a . I cannot even enter (b)(6). I had the implants removed at the end of 2015. I have had years of extensive testing done. Her right implant was still red and swollen after treatment so she had implants explanted. 3502700/81317001515 9555926 I have breast implant illness and will be having the implants explanted very soon. of Irving Texas initiated a recall of their MemoryGel breast implants on July 01, 2016, due to a labeling mix-up Consignees were notified by mail and a follow-up visit by a sales representative Recall terminated December 9, 2016 Symptoms and Side Effects of Defective Breast Implants Any non-affected product and any product returned after the dat. 9550487 I had my Mentor implants placed in 2004 and my health deteriorated after that. Saw an ent and was told i needed to get my deviated septum fixed and thats why i was so tired and had sinus pain. Before sharing sensitive information, make sure you're on a federal government site. 9612274 9589651 Lot Numbers: Link. I take vitamins and try to eat healthy. I had so much pain that it hurt just to be alive. I was a fit, active, mother of four, very health conscious and began noticing debilitating fatigue and joint pain. United States. 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. 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. 3502275/81317001386 Shortness of breath, frequent urination, numbness/tingling sensations in upper and lower limbs, ear ringing, sudden food intolerance and allergies, vertigo. Manufacturer Mentor Texas, LP. Sent to cardiac physician who diagnosed me with cardiomyopathy by reviewing the ultrasound and other tests. Ive seen drs, had tests, multiple lyme and blood tests, xrays, been to physical therapy but nothing. Capsules were thick, yellowish and my chest full of yellow murk liquid. 9582184 No doctor will address issues, none not even physical. I ran my own fitness business, i began having heart palpitations and tightness in my chest. 9547113 9535776 Received mentor silicone breast implants on (b)(6) 2013. I gradually lost the ability to exercise. 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. Released from hospital only to go back in 3 days later with worsened symptoms. 9557444 9602766 Researching now to have my implants removed. I have experienced several problems with my thyroid, heart, severe headaches, etc. I cant wait for my healing to continue and get my life back. Got my implants removed after 8 years in 2015 and 75 percent of the symptoms went away. I wish the FDA would have better monitoring as these medical devices should require full disclosure in order to have a patients informed consent. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. I have a lung issue going onbrochastosis and 800-235-5731. MENTOR Smooth Round Saline DV Implant 350-1697/00081317001331 9596092 Before this surgery, i suffered from insomnia, fatigue, joint pain, back pain, brain fog, hair loss, dry skin, acne, difficulty breathing and others. 9576454 9611963 I even developed (b)(6) 3 weeks after the surgery under my armpit, which ive never had. for Recall. 9534353 By 2007, my health issues had progressed with increased fatigue, emotional lability, gastrointestinal problems, and increased breast pain. a firm capsule was there? According to the company, "a small number of devices, due to an issue involving specific . 9558223 Turns out the textured implants are made with platinum, the same agent used in Cisplatin chemotherapy which causes a permanent ringing in the ear. Lot Numbers: I hadnt changed my address in years. It was reported that the inside of the valve and the outside of the implant had mold. 9571639 9597482 9629166 Visual contrast sensitivity and human beta growth factor tests were administered. 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. 9580873 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. 9541465 The valves on the implants were left in and should have been removed after 6 months post-op. I lost my hope until i realized that the root of all of my problems started when i got breast implants. 9606468 I have a weak immune system, i get cold sores now, recently had an anaphylactic reaction, the list is endless. 9533838 I made several call backs, no assistance. It is hard and painful. Among many symptoms that make me feel like im dying a slow death. Cannot use or smell perfume or scented anything, laundry soaps, hand soaps, dish soaps, body lotion, sprays, candles, shampoo / conditioner, deodorant, cleaning supplies. I also did genetic testing and i am now 4 times fold for celiac, cancer and 90% likely to have breast cancer. 9557442 9563098 9555186 Woke up systemically ill and in widespread body pain. my breast implants due to cancer? 9546175 He has health issues that are related to the toxic exposure while in womb of the leaking implants. In 2002 i began having health problems. I cant take it anymore. 9563940 3502225/81317001362 Based on a decade of research into the safety and efficacy of breast implants, our Mentor Core Study 3 provides evidence to support the unsurpassed design of MENTOR MemoryShape Breast Implants. The FDA needs to know what is going on. Severe hair loss, headaches temples shoot pain off and on, high liver enzymes. It was reported that a female patient underwent bilateral explantation of mentor smooth round high profile saline breast implants. Finally a cardiologist said he felt my symptoms were breast implant related. 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