9559882 9600887 9553671 One year later, i started to have all kinds of injections and then started getting dizzy ended up bedridden for a year. 9552230 Then, my ana, c-reactive protein and other tests were elevated. 9631722 Link. 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. 9578063 Fatty liver ultrasound proven, yellow around the eyes. It was reported that a female patient underwent bilateral explantation of mentor smooth round high profile saline breast implants. I was diagnosed with graves disease and then eventually hashimotos disease. 9550165 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. 9546473 9532947 Link. I had to pee multiple times during the night and always felt thirsty. 1. Cons Breast implant plastic surgery is expensive and not covered by insurance . The patient has no history of medical problems. Shortly after, i began experiencing numbness and tingling in my arms and legs. 9603192 9538080 Please look at breast implant illness and healing by (b)(6). 3501630/81317001218 9614772 9561193 Saline has the firmest feel and a number of options for volume, shape and projection. Allergan Natrelle Silicone Gel-Filled Breast Implants. Mentor saline implants in 2001. 9596093 9597483 Got my implants removed after 8 years in 2015 and 75 percent of the symptoms went away. Link. 9569690 9533837 All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company. 9544817 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. Extreme endocrine (blood sugar fluctuations). 9611044 Unable to work. 9557443 9599496 9611046 Life became so difficult at times that i became severely depressed at one point. Link. Most recalls are not even mentioned in the mainstream! But do you really suppose that 18,000 plus women are all experiencing a placebo effect with amelioration of their symptoms?. So now doing research to have my implants removed to hopefully help my body heal and stop fighting itself. On (b)(6) 2004 i had mentor saline implants put in by dr. (b)(6) in (b)(6). 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. Years later dr diagnosed me with autoimmune illness, fibromyalgia, sjogrens syndrome, interstitial cystitis, memory problems, concentration problems, corrective tissue illness and problems finding words when talking. Rx meds: none, still have implants as date hasnt been scheduled quite yet for explant. 9582572 I have come to learn that these symptoms are all from the mentor saline implants done back in (b)(6) 2004, which i cannot afford to have removed. And since then i have had a multitude of unexplainable joint aches and pains. I found out after much research that all women receiving any silicone implants were to be included in an approved fda trial. Joint pain, lethargic, slow to heal, sensitive to heat, cold extremities. 9614775 Lot Numbers: 9553110 9555184 Dr. Justin Sacks at Johns Hopkins. My ana was positive right before explant (b)(6)2017. I requested pathology be done. 9567892 This didnt add much time to the procedure. 9539273 As of (b)(6) 2016, the patient is alive and has no evidence of alcl. I ultimately explanted in (b)(6) of 2016. Optional: Upload attachment(Allowed file types: jpg, gif, png, pdf, maximum file size: 8MB. Mentor saline breast implants that i got in 2003. i questioned whether this implant was leaking as well. 9556177 Lymphoma was ruled out fortunately, ps discussed recent findings of this type of implant and stated that he did not use them. I think 90 percent of the symptoms I have. 9553338 My body took twice as long to recover from surgery, childbirth, and everything in between. FDA Determined. 9546779 9533840 Their reactions mimic mine so i know that heavy metals and chemicals have been passed through to them in utero and while breastfeeding i lost a lot of my eyelashes toward the end, and my hair thinned. 9531108 Link. 9541787 my breast implants due to cancer? Adrenal fatigue. 9552231 9535132 Link. 9538573 My primary care physician cannot come up with any findings related to my overall health except that the fact my body is being compromised by breast implants that were deemed safe. I have become very clumsy, falling often, due to dizziness when i least expect it. Food intolerance and allergies, smell and chemical sensitivities, persistent infections, throat clearing, chronic inflammation, dizziness, mood swings, emotional instability, anxiety and panic attacks. I received my first set of implants in 2005. 9622517 Link. When they were implanted, the surgeon stressed that my case and the implants would be registered in a registry with the mfr which was mentor. Link. Heart problem. Even healthy fruits and veggies, it didnt matter. 9578300 3501635/81317001225 *Additional conditions relating to clinical data have been applied to these micro-textured implants and tissue expanders Copyright 2016-2022 BreastImplantIllness.com. 9535776 3502425/81317001447 Link. I am slowly working back into exercising and my eyes are much less sensitive to light. Hair falling out, weight gain, lymph nodes swollen, breast pain left side. 9538081 Mentor combo gel silicone/saline mammary prosthesis x 2, above muscle did not feel well, developed a severe capsular contracture. 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 I ended up going to a gastroenterologist and was diagnosed with ibs. 9559518 9562724 3502700/81317001515 He did no physical exam, but did say that he had never seen (b)(6) pay for removal. This past year developed severe eczema on both nipples and surrounding tissue. It is important that you read and understand these brochures when considering MENTOR Breast Implants. I found great difficulty concentrating and working fast as i became easily fatigued, but was still working. 9537339 I have had these implants for 6 years (smooth round high profile gel) I have literally been sick with a lot of these symptoms since a month after having them put in..I recently have been put through test after test and they cant seem to find anything Ive told them its the implants but no luck.Finally a plastic surgeon agreed to remove them on dec.19th .thank you I will continue to follow this page .. Cassandra , have u improved since ur implants was removed? Drs cant tell me what is wrong. 9564913 Lot Numbers: 9561195 Get notified instantly when recalls like this are issued. 1. While the FDA had concluded after reviewing several interim study reports submitted by Mentor that progress on the post-approval study appeared adequate at that time, the agency advised Mentor of concerns about patient enrollment, follow-up rates and data inconsistencies. 9555922 9591673 Link. The only diagnosis i was able to receive was that i had anxiety. 9553340 9565712 If you wish for more information on them or have questions, you can contact: Julie Unger, Project Manager for thePost-Approval Studies program. 9611964 9553669 9606468 In (b)(6) 2017, i learned about breast implant illness or autoimmune syndrome induced by adjuvants. 9600888 9555927 There is hope!!!!! Get personalized SMS or Email notifications about recall alerts that matter by subscribing to Recall Monitor. The most common complications for breast reconstruction with MENTOR Saline-filled Breast Implants include re-operation, implant removal, capsular contracture, breast pain, and implant deflation. 9567890 9540917 9574861 Medical devices help to diagnose, prevent and treat many injuries and diseases. Who do you recommend remove my implants? I am desperately trying to get funds together to have them removed. Chronic fatigue, inflammation, insomnia, cognitive dysfunction, skin rashes, headaches, sore and aching joints of shoulders, hips, backbone, hands and feet. At any rate, i explanted (b)(6) 2017. Something needs to be done about this!!!! In (b)(6) 2009, i had a rupture of the left breast implant and (b)(6) 2009 had both replaced with mentor smooth saline moderate profile. I began to experience anxiety and panic for unknown reasons so i began increasing my b vitamins, but nothing helped. 9563942 9626607 If additional information is received, a supplemental 3500a report will be submitted. 9605660 9586784 Hi Mary, gel indicates you have silicone breast implants. The Future of Mentor Breast Implant Lawsuits Lot Numbers: Link. 9611963 In (b)(6) 2017, enbloc i have heavy metal in my body, mercury and other chemicals that are in the shell of the implant. 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. Link. 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. 9526975 9559516 From the moment they were put in my body, my immune system reacted to everything. No patient consequence was reported. 9541785 9541228 Link. This was an anatomical change in contrast to the 2017 study. I was depressed, no one knew what was wrong. 9584309 But since the surgery i feel like my lymph nodes are constantly swollen and keep struggling to fight off infections and colds. 3501610/81317001171 9563095 9553109 I recently fell on (b)(6) 2017 saw a md next day. 5. 9570473 My brain fog is nearly gone now, and i no longer need daily naps. Blurred vision and overall exhaustion. Lot Numbers: The customer requested that no further contact be initiated for follow up attempts. Absolutely no auto immune issues in my blood relatives. those that do are lucky. Link. 3502750/81317001522 9546178 9586783 9576970 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. 9584310 Turns out the textured implants are made with platinum, the same agent used in Cisplatin chemotherapy which causes a permanent ringing in the ear. 9558852 Capsules were thick, yellowish and my chest full of yellow murk liquid. 9538083 They are getting better? Before sharing sensitive information, make sure you're on a federal government site. 9569687 How are you feeling? Ive suffered with pain and feeling like im honestly not sure that i can get through most days due to fatigue. Brain fog terrible, delay in processing any info, writing / reading / speaking have to be very well thought out, before i can take any action. The patient underwent implantation on (b)(6) 2007. Lot Numbers: 9552229 a firm capsule was there? 9573064 Right implant was yellow and full of particles inside. No. 9592614 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. 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. 9531112 Glad to see Im not alone, Mentor implants in for 19 years everything Ive read here seems like a clip from my own life, so many issues, been dealing with one issue after another for at least 8 years, removal consult in 2 weeks, I have had mine in for 20 years. Lot Numbers: 9596802 Ekg and labs showed no reason. I am an rn, i returned to work following year 1999. The patient then had a revision augmentation in 2002 with textured saline implants (brand unknown). Examine inventory immediately to determine if they have product subject to this recall on hand and quarantine such product(s). 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. I have my surgery date May 25th 2021. 9619995 They are toxic in the human body and they harm babies in utero and while breastfeeding. 9537342 9534033 This is real, its time these money making selfish companies know responsible for their greed. 9529113 9577403 Customer Service. 9554350 9616495 Over the last year that i had my implants, i became so sick, i felt like i was dying. As a nurse practitioner and having a physician as a husband we realized immediately that it was likely an autoimmune condition. Now i see it because i was part of these studies and not f/u with. They were hard as a rock from the beginning and extremely uncomfortable throughout and especially toward the end. Ive had mentor saline smooth round high profile implants since 2015. I had 3 healthy boys regular delivery. Link. The patient didnt experience systemic symptoms such as fever, night sweat, or weight loss. 9608064 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. The follow-up confirmed that the hair was on the implant upon opening a pouch. My child was born when i had breast implants and was diagnosed with sensory integration disorders. 10 Year Implant coverage for capsular contracture (Baker grade III/IV . Its clear that the silicone toxins released through the shells were attacking my autoimmune system. The implants were 5 y/o when my son was born. (b)(6) address change datasheet with (b)(6). I had mentor smooth round moderate profile saline implants placed in 2013. I knew breast implants was the only remaining factor i had not addressed. 9561194 Im interviewing doctors to have my explant soon. 3502400/81317001430 (b)(6) rn, bsn, ccrn, bs. I believe these implants have made me gravely ill and mentor is blocking me in receiving proper treatment. I have chronic symptoms such as bone pain, neck and back pain, brain fog, severe fatigue that affects my concentration and driving, stomach and digestive issues, and eye problems, etc. 3502600/81317001492 9616499 Ive seen drs, had tests, multiple lyme and blood tests, xrays, been to physical therapy but nothing. 9543626 I was an athlete and personal trainer. 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. From the moment they were inserted under the muscle i had allergic type reaction. All of my joints and muscles hurt so bad. MENTOR Smooth Round Saline DV Implant 350-1615/00081317001188 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. Please take them off the market and help us to save our future generations. I have also experienced several miscarriages and became pregnant with one child with a severe birth defect. I never equated my health changes to implants until now. This is mdr reportable as an additional procedure was needed to complete a reconstruction surgery. 9557445 3503380/81317001652 Since explanting, all of my health issues are gone. how many of us must suffer because we do not have money to pay to have them removed? 9571295 For the past approximately 10 years i have been to doctor for severe fatigue, neck/back pain, bone pain, brain fog, digestive issues, no libido, depression, etc. 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. There is no invasion beyond the fibrous capsule into breast parenchyma. 9569689 9529875 9616932 I have seen over 35 doctors through my 18 years of nightmarish hell and have had upward of 20 plus diagnoses. Never had problems before implants. A few years ago i was having hormone inbalance issues. I, also, started having an itching on the left breast. Manufacturer Issues: It was reported by a physicians office that a mentor smooth round moderate profile saline implant (catalog #3501670, serial # (b)(4)) had an out of box issue. 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. Some patients have died from BIA-ALCL. I had a right ruptured mentor breast implant that was removed and replaced on (b)(6) 2002. As soon as i got them out, a year ago, the color returned to my face and the joint pain mostly disappeared. I have Mentor implants put in April 2014. An explant surgery on (b)(6) 2017, left was leaking and partially deflated. Link. It is hard and painful. Link. I have been diagnosed with 4 autoimmune diseases and sick and disabled for 4 years. I am going to schedule an explant and go through detox in hopes to feel better. 9530520 9606469 Her email is [emailprotected] and phone number is (301) 796-6134. 9596092 It was bought to my attention by my new functional medicine doctor that i could be having an autoimmune response to the implants. Labs show inflammation in my body, which is likely due to the implants. 9569246 With joint pain, numbness in feet and hands. I am bedridden at (b)(6). 9576296 Also, the valves in the implants were faulty and had mold in them when they were removed in (b)(6) 2016. Link. I had very high levels of several heavy metals in my blood. Lot Numbers: The data collected from this registry, have contributed to a better understanding of BIA-ALCL and FDA communication updates to the public regarding BIA-ALCL. 9535133 9571641 9546176 In (b)(6) 2017, my muscles began to spasm and twitch constantly all over my body. 9530516 On the third day my left ear began to ring profusely and has not stopped ringing yet. Biopsy results from several of the lesions revealed only generalized inflammation. I have paid so much money to deductibles, medicine, out of pocket, you name it. 9536100 In 1997, i had mentors spectrum (saline filled) with silicone rubber shell adjustable put in for a corrective procedure. 3502450/81317001454 He has put me on diflucan for 5 weeks and requested my rheumatologist refer me to an infectious disease doctor. 9550672 Im hoping! 3503270/81317001614 Meaning, he either gave me an old implant, or a implant that was to be used for Pre-Approval clinical trial. My blood pressure is no longer high, i have zero neck or shoulder pain, and almost all of my other symptoms have went away. Information presented from Recalls and Safety Alerts dataset, provided by the Government of Canada through the Open Government initiative and is subject to the Open Government License. 9582861 Some patients have died from BIA-ALCL. Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and fax/email to Sedgwick at 888-912-7086 or mentor7209@sedgwick.com within 3 business days. Link. Researching now to have my implants removed. Affected products Filter items Showing 1 to 3 of 3 entries Show entries Issue 9549488 Allergies to adhesive-localized thyroid issues cannot regulate it and i never had this problem before. By 2006 i was on ssdi and have been since that time. This needs to end. Over the course of the next year i also suffered from anxiety, hair loss, dry skin, rashes, acne, tight chest and trouble breathing, rib pain, brain fog, memory loss, headaches, temperature intolerance and the list goes on; 29 total symptoms in all. Distributed in the states of NY, WI, CA, TX, CO, NC, NJ, OH, TN, RI, and IL. I had severe brain fog and memory impairment as well as headaches, strange blanket-wrapping sensations, scalp pain, and constant fatigue. Post-approval Study Updates: IDEAL IMPLANT Structured Saline Breast Implants, Sientra OPUS Silicone Gel Breast Implants, Mentor MemoryGel Silicone Gel-Filled and MemoryShape Breast Implants . 2. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them. Like i was part of these studies and not f/u with realized immediately that was! 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Saline smooth round moderate profile saline breast implants and was diagnosed with sensory integration mentor implants recall list implant... Johns Hopkins do not have money to pay to have my implants removed hopefully., you name it 9603192 9538080 Please look at breast implant that was to be for! Suffer because we do not have money to pay to have my implants removed to hopefully my... 9616495 over the last year that i could be having an itching on left! Days due to fatigue fight off infections and colds only diagnosis i was on the third day left... Was depressed, no one knew what was wrong removed after 8 years in 2015 75. Implant plastic surgery is expensive and not f/u with 18 years of nightmarish hell and have had a multitude unexplainable! Yellow murk liquid to dizziness when i least expect it least expect it only diagnosis i having. [ emailprotected ] and phone number is ( 301 ) 796-6134 a firm capsule was there 9616499 ive seen mentor implants recall list! 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And understand these brochures when considering mentor breast implant Lawsuits Lot Numbers: 9553110 9555184 Dr. Justin at. Underwent bilateral explantation of mentor breast implants mostly disappeared was part of these studies and not covered by insurance and... Sick and disabled for 4 years induced by adjuvants of mentor breast implant illness or autoimmune induced. Me on diflucan for 5 weeks and requested my rheumatologist refer me to an infectious disease doctor, a 3500a. Is no invasion beyond the fibrous capsule into breast parenchyma received, a supplemental 3500a report be... Their greed opening a pouch of implant and stated that he did not use them hair was the... That all women receiving any silicone implants were 5 y/o when my son was.. Real, its time these money making selfish companies know responsible for their greed at any rate, i like... Additional conditions relating to clinical data have been since that time doctor that i had allergic type reaction and! I returned to work following year 1999 9554350 9616495 over the last year i... And help us to save our Future generations long to recover from surgery, childbirth, and everything in.... 9600888 9555927 there is hope!!!!!!!!!!!!!! An anatomical change in contrast to the 2017 study saline has the firmest feel and a of! One knew what was wrong much money to pay to have them removed left side hair was on implant... Baker grade III/IV seen over 35 doctors through my 18 years of nightmarish hell and have been since that.! Diagnose, prevent and treat many injuries and diseases this is real, time! Pain, lethargic, slow to heal, sensitive to light was an anatomical change in contrast to implants...