mentor implants recall list
They lie and dismiss my issues. I went to the hospital a countless amount of times, always leaving with no answers. This needs to be recognized by the FDA and the only way for something to be done is for everyone to report it. We expect these manufacturers to meet the pre-specified study requirements in order to ensure the collection of long-term data that can be used to inform long-term patient safety. I was able to coach my daughters basketball team this year for the first time ever. 9573064 9535776 9591673 3501650/81317001256 Doesnt matter I want to feel healthy . 9541788 9550486 Recall Status 1: Terminated 3 on June 13, 2017: Recall Number: Z-2070-2017: . Link. 9587067 Shortness of breath, night sweats and hot flashes, nausea, lightheadedness, brain fog, poor concentration. 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. As of (b)(6) 2016, the patient is alive and has no evidence of alcl. I lost my hope until i realized that the root of all of my problems started when i got breast implants. 9528840 9545543 At any rate, i explanted (b)(6) 2017. Mentor saline implants in 2001. Her right implant was still red and swollen after treatment so she had implants explanted. The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates. Its been a year now and i thank god i have another chance at life. United States. I have paid so much money to deductibles, medicine, out of pocket, you name it. 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. MENTOR Smooth Round Saline DV Implant 350-2175/00081317001348 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. 9551037 He did no physical exam, but did say that he had never seen (b)(6) pay for removal. 9576296 9530727 9567889 And continue to get sick today. I am bedridden and in a state of intractable pain. Breast implants stole 12 years of my life and i am so upset that they are allowed to be put in a womans body. 9546473 I was a fit, active, mother of four, very health conscious and began noticing debilitating fatigue and joint pain. Mentor sent an Recall Notification letter dated March 27, 2017 was sent to . 9528015 9608792 There was no previous history of autoimmune disease. I am slowly working back into exercising and my eyes are much less sensitive to light. The patient reported that her blood is screaming disease and infection. Lot Numbers: 9539275 Cause 2. 9534355 Link. They all said it was most likely lupus and left it at that. Link. 9584036 Fda confirms all are bad, then recall any implants and make mentor, dow corning, allergan, etc pay for full explanation of all implants, including capsule and repair damage done to womens bodies. As soon as i got them out, a year ago, the color returned to my face and the joint pain mostly disappeared. 9554347 I have been dangerously ill for five years now after getting the implants. 18yrs with Saline Mentor. Mentor combo gel silicone/saline mammary prosthesis x 2, above muscle did not feel well, developed a severe capsular contracture. 9545545 9576297 I had mentor smooth round moderate profile saline implants placed in 2013. Adrenal fatigue. 9595427 My ana was positive right before explant (b)(6)2017. Ive had chronic infections since these were placed. 9597482 Lot Numbers: 9542799 9597740 9559881 For instance, FDA staff have coordinated with the American Society of Plastic Surgeons and the Plastic Surgeons Foundation to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (BIA-ALCL) Etiology and Epidemiology (PROFILE), which collects real world data regarding patients who have a confirmed diagnosis of BIA-ALCL. 9553670 Since focusing on nutrition to reduce inflammation, i have lost at least 5 pounds and this is only the beginning to my recovery. It was advised that once the issue was identified, the implant was sent to the back. I am concerned i will not get the proper treatment to get well. 3502550/81317001485 9596093 9553339 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. 9556176 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. It is despicable. I have actually been sick since 2004, but your calendar only goes back to 2007. I am bedridden at (b)(6). Link. After having the implants started having problems with angioedema, idiopathic anaphylaxis, edema, hives. Link. Two prescriptions later and the symptoms never went away. It stated that the implant did come in contact with patient. 9577401 Mentor designed a range of base widths, projection, and volume to enhance your ability to individualize results and provide her with natural, soft-feeling breasts. On (b)(6) i had neck fusion. No relief after surgery. Hypo/hyper adrenal symptoms, estrogen/progesterone imbalance or diminishing hormones, low libido, slow healing of cuts, and scrapes, easy bruising, throat clearing, cough, difficulty swallowing, choking, reflux, metallic tastes, vertigo, gastrointestinal, and digestive issues. 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. Anyone, who enters my world must be fragrance free or i get an automatic headache. Thank you. 9594634 I cannot believe what I have just read all of my health conditions are listed in these posts. 9552232 On (b)(6) 2017 he is a (b)(6) provider and had spoken to me prior. Ever since that surgery, i had left scapular pain. Health product recall MENTOR Saline Breast Implants Brand (s) Last updated 2022-03-10 Summary Product MENTOR Saline Breast Implants Issue Medical devices - Premature failure What to do Contact the manufacturer if you require additional information. Premature aging, weight problems, inflammation, poor sleep and insomnia, dry eyes, decline in vision, vision disturbances, hypo/hyper thyroid symptoms. 9563095 that was produced by Mentor Texas, LP.. A correction or removal action taken by a manufacturer to address a problem with a medical device. Capsular contracture and fungal growth were diagnosed in both breasts/implants upon explantation. Breast Implant Ingredients. A focus-group study to obtain immediate feedback on the patient informed decision brochure from both augmentation and reconstruction patients. I started to experience a change in right breast? 9553111 I have widespread pain, heart palpitations, extreme hair loss, rashes, insomnia, chronic fatigue, migraines, edema all over, etc. Now i read that every symptom could be related to implants. I was an athlete and personal trainer. So much pain and terribly weird sensations, sensitivities and i was only (b)(6). Does anyone have any experience with breast pain? 9610034 Body odor every hole chemical sensitivity. 9546175 9576451 His concern is that this has traveled to my blood. the patient underwent testing but everything returned negative for disease. 9615898 The patient information was not available. 9576452 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. 9547111 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. It was reported that the inside of the valve and the outside of the implant had mold. I also did genetic testing and i am now 4 times fold for celiac, cancer and 90% likely to have breast cancer. I believe i was left out because the investigators used by mentor were not following up with pts as they should have and i think submitting false f/u reports. Affected products Filter items Showing 1 to 3 of 3 entries Show entries Issue 3501640/81317001232 Also, the valves in the implants were faulty and had mold in them when they were removed in (b)(6) 2016. How many years did you have them in??? 9556175 9586122 9582573 9570167 9570169 I had testing done on my eyes to see if my oil glands had degraded. 9620460 Fatty liver ultrasound proven, yellow around the eyes. She claimed that the implants were removed in 2016. The FDA remains committed to thoughtful, scientific, transparent, public dialogue concerning breast implant safety and effectiveness. I was a health woman before I put them in and wish I never had. Link. Link. 9561864 Link. I have Mentor implants put in April 2014. 9600886 9590274 9544816 Link. Patient was required extended hospitalization. 9612273 My doctor said there is nothing that can be done to prevent or fix the deformity once the implants are removed. 9573299 9530918 9559517 Redness was noted on the left breast, and bilateral pain/burning was experienced approximately 5 years post-procedure. 9629494 9552229 Its three weeks post-explant and im down 7 pounds with a completely sedentary existence while recovering from surgery. With joint pain, numbness in feet and hands. Lot Numbers: But no return phone call yet. Right implant was yellow and full of particles inside. In 2013 had a cyst 5cm removed from knee, 2014 miscarriage, 2015 i had 2 miscarriage b implants. My youngest adult son of three children told me there are many women reporting these issues. 9615516 Any problems with tissue expanders being left in for a few years. Note: Parentheses represent redacted information to protect privacy. 9568915 9528017 I was tested for a multitude of disease such as lyme, eb, anemia, ms, als, etc. Didnt feel as strong at the gym wrote it off as low iron. My feet were constantly sore and i had to replace my arch supports every 30-60 days because it was like walking on bones, my foot doctor said my bottoms of my feet were the thinnest he had ever seen. They have many allergies and sensitivities and have similar reactions to things that i have reactions to. I have spoken to the manufacturer. The FDA requested the voluntary recall from Allergan after a "significant increase" in cases of a . The customer requested that no further contact be initiated for follow up attempts. 9543626 He has health issues that are related to the toxic exposure while in womb of the leaking implants. 9529112 Dr. Justin Sacks at Johns Hopkins. 9598143 9599497 9612272 3501685/81317001300 3502400/81317001430 Many of having symptoms even much worse then i. I have mentor smooth saline implants that were placed about 14 years ago. Heat and cold intolerance. I have suffered miscarriages, infertility and severe stomach issues, ibs. , ive been miserable for years and just dont know how to feel better. Saline has the firmest feel and a number of options for volume, shape and projection. The manufacturer had poor follow-up rates with patients. I couldnt eat anything without instantly bloating. I met with two surgeons which confirmed breast implant illness for me and i then scheduled my surgery for (b)(6) 2018. I have several autoimmune diseases and symptoms related to the implants. Optional: Upload attachment(Allowed file types: jpg, gif, png, pdf, maximum file size: 8MB. 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. Feeling off-brain/ nervous system / sensory system similar to how you feel after multiple nights of no sleep. This cancer occurs more commonly in patients with textured breast implants than smooth Implants, although rates are not well defined. 3* *Based on key complication rates (rupture and capsular contracture). 9611602 9535132 Trying to figure out what to do. This didnt add much time to the procedure. By 2004 i found it impossible to work at all, i was only (b)(6). Please help me get all of this out. 9549491 9559883 9586784 I have had numerous disabilities and health issues ever since ranging from thyroid issues, chronic fatigue, cognitive dysfunction, muscle pains and weaknesses. I used to work 80 hours a week and raised 4 children alone. 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. Joint pain, hair loss, heart palpatations, foul body odor, incontinence (relating to muscle issues) rash of autoimmune responses. Manufacturer Reason. The day after my surgery, I noticed my breasts were really hard and I asked the doctor if that was from the swelling. I was 100% healthy before the implants. After some research i found all of my symptoms are that of breast implant illness. 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. 9583791 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. We want to hear from you. Youll have up to two weeks of downtime while you heal. 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 now have heart issues, elevated blood pressure, inflammatory arthritis, lyme disease, morgellons, ulcerative colitis and neuropathy. 9550487 It was reported that a female patient was implanted with mentor smooth saline breast implants in 2002. 9603193 9612274 My pcp checked all labs and my heart and lungs and everything was normal. This request has not been addressed as i am on medicaid. 9530518 9571640 All patients enrolled in the premarket Saline Prospective Study (SPS) will be asked to enroll in this post-approval study. Instructions for Downloading Viewers and Players. I take vitamins and try to eat healthy. Get personalized SMS or Email notifications about recall alerts that matter by subscribing to Recall Monitor. they are able to live again? 9614989 In 2011 at the age of (b)(6) i had a breast augmentation using mentor 3500cc smooth saline implants. 9608795 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. He is wonderful and said I was having a reaction to the implants, and that they needed to come out immediately. 9550484 Post-approval studies (PAS) are conditions of device approval. Link. A sponsors failure to comply with any post-approval requirement may be grounds for withdrawing approval. FDA. Not to mention people thinking you are imagining all of this. Lot Numbers: 9611603 9537339 Starting in (b)(6) 2014, i started having alopecia areata. 9564914 Mentor saline breast implants that i got in 2003. The .gov means its official.Federal government websites often end in .gov or .mil. Implanted with mentor textured implants in 1996. 9594298 9540917 9542801 According to U.S. Food and Drug Administration, this recall involved a device in I was told that these were lifetime devices. The implants were intact upon explantation. I also tested positive for lyme disease. 3502275/81317001386 Depression, diagnosed in 1990 with ms 3 years after original silicone implants. Retrieval study to collect visual examination, physical, and histological dat on explanted implants to determine the mode of failure of implants. I have experienced several problems with my thyroid, heart, severe headaches, etc. I scheduled an explant for 12/02/20. Link. 9557442 Implantation of the MENTORBreast Implants, as well as any subsequent procedures, must be in accordance with current Mentor Product literature and accepted plastic surgical procedures by appropriately qualified licensed physicians for product to qualify for replacement under the Mentor Product Replacement Policy. 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