I look 45 years old. 9537342 9573299 Ultimately, i have been diagnosed with celiac disease, vitiligo, rheumatoid arthritis, hashimotos, 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 actually started feeling ill within a year of my implants. Note: another surgeon in 1996 performed the implantation. 9529385 9589074 Even healthy fruits and veggies, it didnt matter. 9615896 9616497 The FDA may take action for a failure to comply with post-approval orders, including pursuing applicable criminal and civil penalties, where appropriate. 3502600/81317001492 Lot Numbers: 3503310/81317001638 I couldnt pick a date as i have been sick from my mentor saline implants since 2014. Within 6 months i developed autoimmune disorder; candida cystic acne, unexplained weight gain, cold sores, toe nail fungus, brain fog. Customer Service. 9598144 9531108 I wish that dentists, doctors, and all of those in healthcare would get educated and offer a special updated course on what BII is and what it can do to a patients Quality of Life. Lot Numbers: Also started experiencing whole body muscle pain with joint pain, extreme fatigue, and digestive disorders. Link. 9616932 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). None of which i had before implants. Cause 2. 9540916 Affected products Filter items Showing 1 to 3 of 3 entries Show entries Issue Lot Numbers: 9541225 9587326 Adrenal fatigue, hypothyroidism, hashimotos, back and shoulder pain on left side, lower back pain left side, heart palpitations. 9529875 Physician opened another set of implants (lot # 7377332-033) however it was missing domes as well. I am (b)(6). It was advised that once the issue was identified, the implant was sent to the back. 9592613 No additional information has been received to date. 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). I have my receipt, and physician doctor appointment pre-op information, warranty sheet, but no data on serial number, style or lot number. Pain around the chest wall and breasts, muscle twitching, dehydration, chronic neck and back pain. Joint pain, lethargic, slow to heal, sensitive to heat, cold extremities. For Additional Information Contact. Ladies need to be made aware this can happen to them so they can make the decision to risk problems. 9543990 Severe pain in breasts started in 2016 along with drastic weight loss. These incidences spontaneously resolved. 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. 5. 9611601 The patient reports that her health is slowly improving but the nipple pain resolved immediately after explantation. Link. I have spoken to the manufacturer. Re-do surgery done on (b)(6) 1993. Which did continue after this surgery. 3. On 10/11/2021, the Firm sent an "URGENT MEDICAL DEVICE RECALL (REMOVAL)" Notfication via UPS informing customers that breast implants which have expiration dates from 01/01/2025 to 09/30/2021, due to a manufacturing issue may have a potentially weakened area on the base patch portion of the shell. 9550164 9616499 This is mdr reportable as an additional procedure was needed to complete a reconstruction surgery. Manufacturer Reason. 9550485 I explanted a few months later and within a month i had cancer. The fda under the rules of conditions for approval, made mentor do a more aggressive search using the 411 databases. Over the past 20 year time span, I have had all over body psoriasis, chronic migraines, joint aches, left shoulder blade pain, hypothyroidism requiring meds, sinus issues, dry mouth, throat clearing, optic neuritis in my right eye, IBS, pulmonary sarcoidosis, and thumb numbness. I am very healthy, eat healthy, exercise, and live an overall healthy lifestyle. 9568917 Right had capsular contracture. 3501690/81317001317 4. 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. 3502325/81317001409 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. Six months after receiving the implants, the patient underwent a full hysterectomy, as the physicians thought that perhaps her issues were hormonal in nature. Drs cant tell me what is wrong. 9615517 9595425 The implants were found with faulty valves and mold. 9602499 9540917 After approx 7 yrs i started having problems communicating. Finally, i developed a goiter and a high cortisol level. 9580415 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). 9554350 9563941 9540919 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. They felt i was depressed with four kids. The patient reported that her blood is screaming disease and infection. 9631722 The patient underwent bilateral explantation with total capsulectomies and no replacement implants in (b)(6) 2016. Was given two weeks to live if no treatment. 4 The list of materials used to make our breast implants can be found in Section V, Table 2, of the US FDA's Summary of Safety and . Other financial assistance (from date of implant) Up to $2,000 for capsular contracture (Baker grade III/IV) for two (2) years. Im interviewing doctors to have my explant soon. MENTOR Smooth Round Saline DV Implant 350-2175/00081317001348 The patients known implant history is the following: the patient had bilateral augmentation in 1992 with unknown implant brand, texture, and fill. Issuing Office: Center for Devices and . 800-235-5731. 9555926 The manufacturer had poor follow-up rates with patients. 9604456 Lot Numbers: 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. It made me look like someone with brain damage when i would be talking and all of a sudden either couldnt think of a word i needed to use in a sentence or lose my train of thought completely. On monday (b)(6) 2017, i went to (b)(6). 3501630/81317001218 I lost the ability to digest meat properly, and had to eat mostly fruits, veggies and beans. Shortly after, i began experiencing numbness and tingling in my arms and legs. 9547972 This past year developed severe eczema on both nipples and surrounding tissue. Every part of my body was shutting down and no dr. Could tell me why. i no longer had shortness of breath. I dont want perky breasts!! Almost 95 percent of these symptoms have went away since i have explanted. 9555186 9549489 9571295 I have seen over 35 doctors through my 18 years of nightmarish hell and have had upward of 20 plus diagnoses. 9553339 9592326 Those implants caused my leukemia all ph+. Mentor saline breast implants caused hashimotos and sjogrens auto immune. Mentor Worldwide LLC & Acclarent. 9549490 Mentor implants have a high patient satisfaction rate, with 94% of RealSelf reviewers saying their results are Worth It. 9619671 my first ones were removed via the area incision and now i have an incision in the inframammary location. 9534353 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). Implants should be taken off the market, they are so hazardous to our health. Link. 9547113 9578301 9578064 9590027 9549491 Currently, the manufacturer reported a follow-up rate of 61 percent, which is below the target follow-up rate. As soon as i got them out, a year ago, the color returned to my face and the joint pain mostly disappeared. 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. 9535387 9534355 9534354 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. FDA Documents: Approval Date: November 17th, 2006 Recalls FDA Overview - Mentor MemoryGel [] 9552229 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. Same here. This is real!!!! IMPORTANT SAFETY INFORMATION: See reference section below for a Black Box Warning for breast implants and important safety information. No. 3501660/81317001270 Was the surgery difficult and painful? 9569246 Device was sent back to mentor. Never was i contacted for any f/u. Breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). I love my breasts but I have SO MANY of the symptoms listed here. 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. If you are having symptoms, get your implants out NOW and save your life. capsule had gone away? 9564916 Lot Numbers: 9607486 9565272 9556604 9550484 9563943 To receive credit reimbursement, customers must return product subject to this recall. Link. The patient has no history of medical problems. It stated that the implant did come in contact with patient. I have Mentor saline impants and their 11th birthday is next month. 9541466 9589652 Link. 9612273 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. This included all body hair (underarms, pubic, legs) as well as any head hair. 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. Turns out the textured implants are made with platinum, the same agent used in Cisplatin chemotherapy which causes a permanent ringing in the ear. During the next 6 months to 12 months i went through hyperthyroidism and then hypothyroidism. 9538081 My health has been on the decline for years now. 3503250/81317001607 9550672 The restrictions on sale and distribution are included in the Post-Market Approval (PMA) Supplement Approval letter for these implants. Recall Status 1: Terminated 3 on June 13, 2017: Recall Number: Z-2070-2017: . 9528840 It was reported that fill tube and check valve were missing from box of implant (b)(4) (p/n: 3502350; l/n: 7381657-018). But do you really suppose that 18,000 plus women are all experiencing a placebo effect with amelioration of their symptoms?. 9562722 9562723 There was no previous history of autoimmune disease. 9614479 Got saline breast implants. One year later, celiac, other food allergies, biotoxin illness, severe symptoms that were debilitating, digestive issues, leaky gut, chemical sensitivity, light and sound sensitivity. I went to see dr. (b)(6) in (b)(6). 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. The 5,990 incidents were submitted in bulk by breast implant makers Allergan and Johnson & Johnson affiliate Mentor on three dates in 2019: Jan. 14, June 26 and Nov. 7, according to CBC's. Mechanical testing (i.e., fatigue rupture and shelf-life) to collect additional data. I continue to work, but have such horrible brain fog that it worries me. All implants for breasts, saline, silicone, textured and smooth, should be recalled and all parent companies should pay. 9614775 9608795 9632676 9535386 9600886 The patient reported severe nipple pain, fatigue, joint pain, hair loss, and overall sickness. Also, the valves in the implants were faulty and had mold in them when they were removed in (b)(6) 2016. My surgeon retired. Lot Numbers: I was a health woman before I put them in and wish I never had. There was no accident or impact to cause the implants to leak. 9528841 In July 2019, the FDA requested that Allergan recall its Biocell textured breast implants because they had been linked to BIA-ALCL, or breast implant-associated anaplastic large cell lymphoma, a rare cancer. The patient underwent removal without replacement on (b)(6) 2018. Link. My eyes and mouth became unbearably dry. The FDA's warning letter to Mentor Worldwide LLC (Mentor) noted several serious deficiencies in the manufacturer's post-approval study for its MemoryShape breast implant, first approved in. 9574052 I ended up having to leave my job due to these disabilities. 9599498 Link. 9553338 The lymphoma cells were found in the effusion fluid surrounding the implant and in the fibrous capsule. 9608402 9575829 There was no patient contact. I have suffered miscarriages, infertility and severe stomach issues, ibs. The FDA requested responses from both manufacturers within 15 working days of the issuance of the warning letters, with details about how the noted violations will be corrected. 9546176 (b)(6). He sent me on a chase for medical records 23 years old. Lot Numbers: I believe these implants have made me gravely ill and mentor is blocking me in receiving proper treatment. 9538573 9546471 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. Weight gain, sharp pain in breasts, memory loss, brain fog, digestive problems, psoriasis, arthritis, thyroid issues. How are you feeling? Lot Numbers: Link. Visual contrast sensitivity and human beta growth factor tests were administered. 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. So i am reporting my situation. Any problems with tissue expanders being left in for a few years. On (b)(6) 2016, the patient was diagnosed with bilateral stage ie alcl (cd30 positive, alk negative) via aspiration cytology. Lot Numbers: They should be remove from all surgeries. Link. 9571641 9558224 Blurry vision, visual disturbances, bruising takes months to heal, wounds take months to heal. But no return phone call yet. No product issue, such as rupture, was reported. 9580875 The customer requested that no further contact be initiated by mentor for more information. No Dr will say implant illness, it is cosmetic surgery. 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. 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. The addition of prescription eye drops that helped, but my eyes were still red and dry. Weight gain i had literally tried nearly every diet and exercise program that exists and maybe lost a pound or two with significant exercise. Capsular contracture and fungal growth were diagnosed in both breasts/implants upon explantation. 3502200/81317001355 Don't be at the mercy of a late news segment or a social share. 9582184 My left implant ruptured 2 weeks ago. My mentor saline implants that i got back in (b)(6) 2008 were making me extremely sick. 9534031 The patient then began having problems in left breast (capsular contracture) and underwent revision procedure with unknown implant brand, texture, and fill. 9575830 9592325 I still struggle with gut issues and joint pain. I was never contacted and i was more than easy to find. 9580874 I had mentor smooth saline with silicon shell breast implants implanted in (b)(6) 1999. 9559517 On (b)(6) i had neck fusion. 9571640 Hashimotos thyroiditis, rheumatoid arthritis, scleroderma, lupus, sjogrens syndrome, nonspecific connective tissue disease, multiple sclerosis, symptoms of or diagnosis or bia-alcl lymphoma. Mentor Texas LP. 9583792 FDA Documents: Approval Date: May 10th, 2000 Medical Device Recall Search The health consequences of a ruptured silicone gel breast implant have not been fully established. Lot Numbers: It resolved with detoxing and i have residual lung scarring but no asthma or copd. 9591673 9563097 9527434 I have breast implant illness and will be having the implants explanted very soon. I was treated by several different dermatologist with steroids im as well as into the bald patches on my head. 9566957 Link. I also developed asthma, and allergies to foods that were never an issue before. 9602500 Hi Laura, Link. 9526975 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 wish the FDA would have better monitoring as these medical devices should require full disclosure in order to have a patients informed consent. 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. Trying to figure out what to do. 9614772 i was crying in pain, and reporting right breast issues, as well as left. Link. 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. 9567249 7. 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. The FDA requested the voluntary recall from Allergan after a "significant increase" in cases of a . 9557444 9537339 He believed i had sleep apnea. 9529112 Exactly 3 months later i began having pain and swelling in my neck. Heat and cold intolerance. Pain, i underwent ultrasounds and blood tests again, no findings. 9551039 I had them removed (b)(6) 2017 and have experienced major healing. After having the implants started having problems with angioedema, idiopathic anaphylaxis, edema, hives. Post-approval requirements are critical to ensuring the safety and effectiveness of the medical products we regulate and well continue to hold manufacturers accountable when they fail to fulfill these obligations, said FDA Commissioner Scott Gottlieb, M.D. Please help take these off the market and save lives. Prosthesis, breast, noninflatable, internal, silicone gel-filled - Product Code FTR. 9573298 9554349 9553109 9561864 My body ached on a daily basis. I am having horrible issues and what mine out! 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. PLEASE everyone file your reports to the FDA. Link. 9602766 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. No additional procedure was required, and no adverse event resulted from this incident. It has been 1.5 years. The valves on the implants were left in and should have been removed after 6 months post-op. Link. 3501645/81317001249 Approx 5-6 years later, i started experiencing health problems that included fatigue and breast pain. 9574861 3501620/81317001195 9536098 The FDA remains committed to thoughtful, scientific, transparent, public dialogue concerning breast implant safety and effectiveness. I am an rn, i returned to work following year 1999. 9596091 9603193 1. I think 90 percent of the symptoms I have. Chief resident dr. (b)(6) verified breast deflation, but did not allow an appt, that is coveted by (b)(6). Link. 3503290/81317001621 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. 9545544 There was a stalling hair loss for a period of time, but resumed fall out with complete hair loss by (b)(6) 2014. 3503230/81317001591 Additionally, the FDA has worked with multiple stakeholders to facilitate the development of the National Breast Implant Registry (NBIR) to provide a platform for collecting additional real world data on the safety and performance of breast implants. 9578066 9547974 More than 10 numbers, contact manufacturer. Have had several health issues since. 9550165 Released from hospital only to go back in 3 days later with worsened symptoms. 3502350/81317001416 9619316 9559881 So I called Mentor, they have his name in their data base, but say he didnt report any implants nor did he place an order for an implant until December of 2001. 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. Fatty liver ultrasound proven, yellow around the eyes. I dont want to be sick, but what can I do? 9543628 9564279 Link. 3502650/81317001508 Biopsy results from several of the lesions revealed only generalized inflammation. 9619996 I had my breast implants removed with muscle repair on (b)(6) 2017 and all my symptoms are gone. Lot Numbers: 9612275 Is this silicone? 9546779 1. I have had Mentor Saline since 2009. Lot Number: Right implant is deflated. 3501655/81317001263 Sent to cardiac physician who diagnosed me with cardiomyopathy by reviewing the ultrasound and other tests. 3503560/81317001690