9562723 Patient had implants in for 10 yrs. Explanted (b)(6). Ibs, osteoporosis, told i have lupus and ra, but negative blood work. About 23 years ago i was implanted with (b)(4) saline breast implants. The FDA requested the voluntary recall from Allergan after a "significant increase" in cases of a . You can access this data free of charge via Recall Monitor, or through the Healthy Canadians website. 9559141 9528580 Doesnt matter I want to feel healthy . 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. 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. In 2008 she was diagnosed with anaplastic large cell lymphoma. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. 9605660 9567891 This has been going on since Monday. I had mentor saline breast implants augmented under the muscle in (b)(6) 2006 at the age of (b)(6). 9575830 It was reported that a (b)(6) female patient underwent stage one reconstruction surgery with saline smooth round spectrum implants. 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. I survived by using lists in everyday life. Link. 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. My pcp checked all labs and my heart and lungs and everything was normal. I am having the implants removed on (b)(6). At no time did i connect the rashes, joint aches, or weight gain (heck i thought it was menopause) to the breast implants. In 1997, i had mentors spectrum (saline filled) with silicone rubber shell adjustable put in for a corrective procedure. Breast implants stole 12 years of my life and i am so upset that they are allowed to be put in a womans body. For 10 years my body battled the toxins, biofilm, heavy metals from the implants and finally gave out trying. 9569689 I am 72 y.o. 9537340 Capsular contracture and fungal growth were diagnosed in both breasts/implants upon explantation. 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. I went to see dr. (b)(6) in (b)(6). 9574860 Immediately, my breathing was cured! Severe gut pains, bone pains, swelling in hands, stiffness in legs. Despite being in total shock that this male muslim doctor decided to go against my choice of implants, within a few days I began to have major symptoms. Cons Breast implant plastic surgery is expensive and not covered by insurance . My body ached on a daily basis. Before sharing sensitive information, make sure you're on a federal government site. Irvine, CA 92618. Link. 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. 9532948 The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates. Her right implant was still red and swollen after treatment so she had implants explanted. The FDAs actions today are part of the agencys ongoing commitment to its public health mission of ensuring patient access to safe and effective medical devices. 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. a nurse since (b)(6), i find this deeply disturbing. Eczema on about 50 percent of my body as well. 9534033 I had them removed (b)(6) 2017 and have experienced major healing. By that time the patient was on the table. Shortness of breath, night sweats and hot flashes, nausea, lightheadedness, brain fog, poor concentration. I never equated my health changes to implants until now. 9614478 The implants were 5 y/o when my son was born. The patient then had an infection and underwent explantation without replacement. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. 1. 7. Joint pain excruciating pain, opening milk, jars, car seats and bottles are impossible. 9528841 9539276 Over the last year that i had my implants, i became so sick, i felt like i was dying. Link. Breast implant illness is a real condition and needs to be explored further and of public health concern. Cause 2. 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. 9629166 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. Lot Numbers: I am an rn, i returned to work following year 1999. The patients known implant history is the following: the patient had bilateral augmentation in 1992 with unknown implant brand, texture, and fill. Ever since that surgery, i had left scapular pain. 9585571 We want to hear from you. They felt i was depressed with four kids. 9620460 They are getting better? 9547112 (b)(6). Never was i contacted for any f/u. 9571641 9536100 I have also had surgeries for those joint problems. 9556605 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. in 2000 i got mentor spectrum adjustable implants; 5 years ago i started getting sick. I then began having issues with female health, cysts during ovulation, fibrous dense breast tissue that eventually also led to cysts. 9591675 Lot Numbers: 9619995 FDA Documents: Approval Date: November 17th, 2006 Recalls FDA Overview - Mentor MemoryGel [] The root cause of the patients symptoms are unclear. Ive suffered with pain and feeling like im honestly not sure that i can get through most days due to fatigue. 9550486 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 even forgot to take my morning eye drops yesterday because they were moist and didnt hurt. Link. Explanting asap. 9565272 But my right breast has for the last few years been inflamed and has drainage. I contacted mentor to ask about my warranty and was helped by a supervisor named (b)(4). 9587328 I stopped making any strength or cardio goals and also gained about 25 pounds slowly over the following 3-4 years. Im trying to pick a doctor now. I cant take it anymore. After some research i found all of my symptoms are that of breast implant illness. 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 its not pulling the breast tissue when i flex. 3502550/81317001485 9553111 3502600/81317001492 The manufacturer had poor follow-up rates with patients. 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. Plastic surgeons refuse to do it even though (b)(6) providers, they refused to remove capsule, they want money upfront. 6. 9535132 Affected products Filter items Showing 1 to 3 of 3 entries Show entries Issue 9537342 Woke up systemically ill and in widespread body pain. 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. 9614775 9576451 Hi Mary, gel indicates you have silicone breast implants. Hashimotos thyroiditis, rheumatoid arthritis, scleroderma, lupus, sjogrens syndrome, nonspecific connective tissue disease, multiple sclerosis, symptoms of or diagnosis or bia-alcl lymphoma. 9587065 I began to experience anxiety and panic for unknown reasons so i began increasing my b vitamins, but nothing helped. Bruising on body, brain fog, joint muscle chronic pain, body swollen, use walker or cane. 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. Some days I feel like I am laterally dying! No additional information has been received to date. 9553671 9564914 Link. Any news on this condition and Some symptoms have already gone away and some have gotten better. Any time i used any joint, whether it was my wrist on my shoulder, it would hurt for the next 5 days. I am very healthy, eat healthy, exercise, and live an overall healthy lifestyle. 9541786 Got saline breast implants. 9617818 9583793 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. Allergies to adhesive-localized thyroid issues cannot regulate it and i never had this problem before. I had a saline breast implant rupture (b)(6). Lot Numbers: 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. Im feeling lost & consumed with chronic pain. I would not have been able to stand on my feet for that long before, when i had implants. 3502200/81317001355 It was advised that once the issue was identified, the implant was sent to the back. 9596091 It was reported that fill tube and check valve were missing from box of implant (b)(4) (p/n: 3502350; l/n: 7381657-018). 9589073 Implants should be taken off the market, they are so hazardous to our health. 9629900 My sickness started about a year later. 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. 9569687 After implants, my hormone levels plummeted (ive been to specialist who could not help me) and they were 100% healthy a month before implants. Link. It resolved with detoxing and i have residual lung scarring but no asthma or copd. The destruction they cause is not ok. 9580414 Per the contact, there was no significant procedural delay, and the procedure was completed with a fill valve that the hospital had available. Within a year i developed a hernia, then had another hernia the following year. I was a health woman before I put them in and wish I never had. Link. 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. 9530916 As an adult performer, my breasts are part of my livelihood and I am so scared now. The patient has no history of medical problems. 9536099 Link. There was no previous history of autoimmune disease. Especially the last year. Among many symptoms that make me feel like im dying a slow death. 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. The pains chronic and worse now that Ive decided to stop the use of Fentanyl (late Jan. 2018). In (b)(6) 2018, i came across a website about breast implant illness. 9576296 9561861 Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Canada, Spain, UK, Germany, France, Korea, Australia, Taiwan, Belgium, Ireland, Turkey, and Singapore. Swollen, use walker or cane underwent explantation without replacement pain excruciating pain opening... Or cardio goals and also gained about 25 pounds slowly Over the last few years been and. 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