Approximately two weeks after the procedure, the patient began to experience a number of symptoms, including extreme anxiety, numbness, tingling, joint pain, brain fog, memory loss, confusion, vision problems, food allergies, difficulty walking, breathing issues, muscle atrophy and hormonal issues. 9594634 Skin rashes, heart palpitations. She also reports headaches, brain fog, joint pain, body aches, chronic fatigue, dry eyes, weight loss, digestive system issues, sore feet, and increased recovery period from any surgery. I scheduled an explant for 12/02/20. Link. 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. 5. for Recall. No patient contact information was provided. Adrenal fatigue. Then, my ana, c-reactive protein and other tests were elevated. Explanting asap. 9584309 3502700/81317001515 Ekg done due to breathing difficulty and swollen ankles. It was reported that a female patient was implanted with mentor smooth saline breast implants in 2002. 9576297 I had 29 of the 50 symptoms listed, i then found a group of over 50,000 women who were all suffering just like i was. Link. Lot Numbers: In 2008 she was diagnosed with anaplastic large cell lymphoma. Lot Numbers: 13 December 2022 Listen In October 2019, the TGA took steps to improve the safety of breast implant products in Australia. No family history, no alcohol induced cardiomyopathy. Link. Patient outcome has since improved, with lingering food allergies, gut issues and mold/chemical sensitivity. 9583792 The customer requested that no further contact be initiated by mentor for more information. 9543991 Medical Device Recall of MENTOR Smooth Round Saline DV Breast Implants Page 1 of 6 Event #7209. As a nurse practitioner and having a physician as a husband we realized immediately that it was likely an autoimmune condition. Lot Numbers: 9563942 Today, the U.S. Food and Drug Administration issued warning letters to two breast implant manufacturers for failure to comply with their requirements, under their premarket approval orders, to conduct post-approval studies to assess the long-term safety and risks of their silicone gel-filled breast implants. He sent me on a chase for medical records 23 years old. 9596802 On (b)(6) 2016, the patient was diagnosed with bilateral stage ie alcl (cd30 positive, alk negative) via aspiration cytology. 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. 9540920 , ive been miserable for years and just dont know how to feel better. 9568917 9541785 After my breast augmentation, i started to get intense neck and shoulder pain along with numbness in my hands and fingers. It is reported that a patient had both mentor implants sal smooth rnd diap 350cc (catalog#3501655; lot# : 5547192-088) removed due to severe nipple pain, body was rejecting implants. I had the mentor saline implants 14 years ago. 9552229 Now i am researching how to get them properly removed. Dr. Justin Sacks at Johns Hopkins. 9617819 9533840 9570473 The FDA advises women with BIA-ALCL to have their implants removed. 9554347 They are getting better? Not only do implants cause immune system cancer as recently released by your administration, but it begins with a snowfall effect of damage to the immune system. I was diagnosed with ibs in 2012 and started experiencing generalized muscle pain and increased fatigue. Lot Numbers: This report is for the one of the two implant. Pain, i underwent ultrasounds and blood tests again, no findings. By that time the patient was on the table. 9578299 Do you think that made a difference in the muscle deformity? Is this silicone? 9558225 9592327 I wish the FDA would have better monitoring as these medical devices should require full disclosure in order to have a patients informed consent. 9541225 I had a full hysterectomy six months after getting the implants. This is no coincidence, and women are getting more sick every day that passes with breast implant illness. I contacted mentor to ask about my warranty and was helped by a supervisor named (b)(4). In 15 months, i saw 6 different drs and had multiple blood tests done. Doctors were baffled because lab testing was normal for some time. I waited 10 years to have implants because I was afraid after going through a bi-lateral mastectomy. 9533290 Lot Numbers: Explanted (b)(6). The date above is around the time that i had my mentor saline breast implants put in. 9544819 Therefore, all known case details are provided and no additional information is available. 3502325/81317001409 Any problems with tissue expanders being left in for a few years. Their immune systems are overreactive to everything. 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). Got my implants removed after 8 years in 2015 and 75 percent of the symptoms went away. 9590273 Link. 9535131 9629494 As a pt and an rn, i felt that was not given accountability by mentor due to the findings that came out after my initial implantation. I believe this is all due to my saline mentor implants. 9590029 9624985 There was no patient contact. Mentor MemoryGel Silicone Breast Implants: Scroll down for a list of symptoms women have reported to the FDA and for reports of mastectomy and reconstruction cases, fungus, body parts removed, manufacturer issues, BIA-ALCL, other cancers, and pre and post approval study follow-up. 3502450/81317001454 9602500 After implants, my hormone levels plummeted (ive been to specialist who could not help me) and they were 100% healthy a month before implants. 9529384 I met with two surgeons which confirmed breast implant illness for me and i then scheduled my surgery for (b)(6) 2018. I have also had surgeries for those joint problems. 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. Recall Monitor is not endorsed by, or is an official product of the Government of Canada. 9598143 According to the company, "a small number of devices, due to an issue involving specific . 3502400/81317001430 9578301 In 2011 at the age of (b)(6) i had a breast augmentation using mentor 3500cc smooth saline implants. The patient didnt experience systemic symptoms such as fever, night sweat, or weight loss. As part of the Medical Device Safety Action Plan, the FDA committed to streamlining and modernizing how the agency implements postmarket actions to address device safety issues to make responses to risks more timely and effective, including taking actions against manufacturers when their postmarket studies are non-compliant with any study requirements. 9549489 9599496 The correlation makes sense to me. In (b)(6) 2017, enbloc i have heavy metal in my body, mercury and other chemicals that are in the shell of the implant. 9606471 9610033 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. 9614774 Mentor Saline Breast Implants IMPLANT SERIAL NUMBER RECALL Products can fail, either instantly or over the years. Get personalized SMS or Email notifications about recall alerts that matter by subscribing to Recall Monitor. Therefore, explanted in (b)(6) 2018. Breast implant illness is a real condition and needs to be explored further and of public health concern. 9568918 Within 6 months i developed autoimmune disorder; candida cystic acne, unexplained weight gain, cold sores, toe nail fungus, brain fog. 9528840 Which did continue after this surgery. I ended up going to a gastroenterologist and was diagnosed with ibs. There is hope!!!!! Rashes and sensitivities to any lotions, perfumes. Shortly after, i began experiencing numbness and tingling in my arms and legs. Severe pain in breasts started in 2016 along with drastic weight loss. 9611604 Thank you friend, hope youre feeling better! those that do are lucky. Link. 9622909 With joint pain, numbness in feet and hands. 9537339 Link. Retrieval study to collect visual examination, physical, and histological dat on explanted implants to determine the mode of failure of implants. 3502225/81317001362 Lymphoma was ruled out fortunately, ps discussed recent findings of this type of implant and stated that he did not use them. 9595693 I also developed asthma, and allergies to foods that were never an issue before. Implanted with mentor textured implants in 1996. Don't be at the mercy of a late news segment or a social share. Six months after receiving the implants, the patient underwent a full hysterectomy, as the physicians thought that perhaps her issues were hormonal in nature. MENTOR Smooth Round Saline DV Implant 350-1615/00081317001188 9535387 Skin wound healing problems, bleeding disorder called von willebrands and severe allergic reactions, which caused me to be on life support and no other cause. 9603191 How do I tell? 9546176 Gloves were changed, and procedure was completed with a new implant. Chief resident dr. (b)(6) verified breast deflation, but did not allow an appt, that is coveted by (b)(6). 9555927 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. After approx 7 yrs i started having problems communicating. Severe gut pains, bone pains, swelling in hands, stiffness in legs. Lot Numbers: 3501640/81317001232 9534353 9546471 6. So much pain and terribly weird sensations, sensitivities and i was only (b)(6). 9589073 PVCs months after & hyperthyroidism, hair thinning, anxiety ALL few months after saline smooth implants. 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. 9541786 The fda under the rules of conditions for approval, made mentor do a more aggressive search using the 411 databases. There was no previous history of autoimmune disease. But my right breast has for the last few years been inflamed and has drainage. 1. 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. Optional: Upload attachment(Allowed file types: jpg, gif, png, pdf, maximum file size: 8MB. 9614988 3503330/81317001645 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. 9612275 Some insurance companies with assist i having them removed if there is a rupture or they were implanted for reconstruction due to cancer, but i could not find a plastic surgeon that would take them out with insurance paying. 9617818 Im scheduled for lumpectomy and also explant. 9561863 Chairman, Board of Directors and Chief Executive Officer. 9553670 Which led to an ablation attempt and eventually ended with hysterectomy last year. It was reported that the inside of the valve and the outside of the implant had mold. On (b)(6) 2017, i had the mentor implants removed and no implant replacement. 9594299 9553671 They lie and dismiss my issues. I have no family history of auto-immune disease. I had an mri conducted with and without contrast and saw an ms specialist who was not concerned that i had ms. Mentor Saline implants. Mentor sent an Recall Notification letter dated March 27, 2017 was sent to . Link. 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. Lot Numbers: I believe i have bii (breast implant illness). There should be some kind of warning about the dangers of breast implants. Low white blood count. 3503310/81317001638 I was told by my surgeon that since silicone was banned that i would need special approval to get these implants. 9571294 9583793 I know something is going on, but because doctors have deemed me a mystery, I dont want to see anyone. From the moment they were put in my body, my immune system reacted to everything. But do you really suppose that 18,000 plus women are all experiencing a placebo effect with amelioration of their symptoms?. I found out after much research that all women receiving any silicone implants were to be included in an approved fda trial. Lot Numbers: 9538571 Not just that, but i hope women can know how severe it can be and how often it is occurring. 9592325 I developed reoccurring breast cellulitis due to 10 year old saline breast implants. If you have a chance, please also fill out a MedWatch Voluntary Reporting Form to the FDA with your symptoms and history progression similar to these reports submitted above so it can be documented with the FDA and then likely be submitted to Mentor. 9546175 The . Link. 9558850 Swollen armpit lymph nodes daily, mammogram clear. 9583025 (b)(6) rn, bsn, ccrn, bs. Released from hospital only to go back in 3 days later with worsened symptoms. Lot Numbers: The implants were 5 y/o when my son was born. Link. Lot Numbers: 9553109 Link. This is not ok!!!!! 9602499 Other problems have been, brain fog, sad, allergies consistently, heavy periods at age (b)(6) and had to have cryoablation, cystic breasts with one biopsy (neg) and several aspirations of cysts, and finally the most recent, feeling of helplessness because of all my aching joints. Recall Status 1: Terminated 3 on June 13, 2017: Recall Number: Z-2070-2017: . 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. Among many symptoms that make me feel like im dying a slow death. Im going in this month for toxins testing. 9598142 9532948 Lot Numbers: I think my immune system started deteriorating in 2010, however, being so physically fit, the symptoms were masked until 2013. Now i read that every symptom could be related to implants. At 105 pounds, she had A-cup . Patient had implants in for 10 yrs. The research person on the phone was very dismissive and said that such records were not kept. My health has been on the decline for years now. The patient also experienced seroma. 3503230/81317001591 9538573 Rx meds: none, still have implants as date hasnt been scheduled quite yet for explant. 9580873 I had mentor smooth saline with silicon shell breast implants implanted in (b)(6) 1999. 3501685/81317001300 9538083 I couldnt eat anything without instantly bloating. I have become very clumsy, falling often, due to dizziness when i least expect it. 9531109 9543357 Lot Numbers: It resolved with detoxing and i have residual lung scarring but no asthma or copd. 9594296 I have been feeling terrible for at least the last ten years or more. 9590274 9565714 I had 3 healthy boys regular delivery. 9584308 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. 9570166 Per the customer, the implant did not come into contact with any patient. Lot Numbers: 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. 9550673 FDA Determined. Link. 9611048 The patient underwent explantation with replacement on (b)(6) 2016 when the surgeon noticed mold in the valve area of both implants :it was described as dark green, brown and black and it was reported that some particles were also in the patient. 9619316 He believed i had sleep apnea. I have explanted and i no longer take any psych meds. It is important that you read and understand these brochures when considering MENTOR Breast Implants. United States 9616933 9550487 Extreme endocrine (blood sugar fluctuations). 9608404 This is mdr reportable as an additional procedure was needed to complete a reconstruction surgery. 9606468 Link. Over the 12 years i had them in my body. A focus-group study to obtain immediate feedback on the patient informed decision brochure from both augmentation and reconstruction patients. My life has been ruined! 9602766 9529876 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. 3501670/81317001287 9590027 So i am reporting my situation. Hair falling out, weight gain, lymph nodes swollen, breast pain left side. 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. 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. Capsular contracture and fungal growth were diagnosed in both breasts/implants upon explantation. 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. 9583026 I am still trying to find if it had ever been recalled. 9577401 Please do something. 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. 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. 9587326 10 Year Implant coverage for capsular contracture (Baker grade III/IV . FDA Documents: Approval Date: May 10th, 2000 Medical Device Recall Search Link. There is no invasion beyond the fibrous capsule into breast parenchyma. I have seen many doctors during these last years and no one ever could find a source. 6. Since explanting, all of my health issues are gone. 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. 800-235-5731. 9551039 I was near death and couldnt figure out what happened. 9567250 But no return phone call yet. 9595691 9584310 9565713 9576684 Lot Numbers: I will explant next week to get my life back. Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. 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. Link. Two prescriptions later and the symptoms never went away. Also, i had 2 revisions to discover the implants were on nerves. 3503250/81317001607 Link. January 2020 kidney stones removed, blood work pretty good other than low iron still, then in November 2020 high liver enzymes and 2021 diagnosed with autoimmune hepatitis. 9576970 9559881 I had them removed (b)(6) 2017 and have experienced major healing. No patient consequence was reported. 9565270 The patient did not receive chemotherapy or radiation therapy. Premature aging, vision disturbances, digestive issues. Link. 9553340 Mentors failure to address these concerns and comply with its post-approval study requirements is a violation of the firms pre-market approval order. 9578065 9615518 Does anyone have any experience with breast pain? 9582183 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. Feel like Im slowly dying. Link. Blurred vision and overall exhaustion. Its been a year now and i thank god i have another chance at life. I stopped making any strength or cardio goals and also gained about 25 pounds slowly over the following 3-4 years. 9556177 Researching now to have my implants removed. 9550672 This needs to be recognized by the FDA and the only way for something to be done is for everyone to report it. The patient then began having problems in left breast (capsular contracture) and underwent revision procedure with unknown implant brand, texture, and fill. 3503500/81317001683 MENTOR Saline-Filled Breast Implants are inflated to the desired size with sterile isotonic saline before implantation, as well as postimplantation. I had my breast implants removed with muscle repair on (b)(6) 2017 and all my symptoms are gone. 9572393 9569248 Lot Numbers: However the delay caused a potential risk to the patient. I see your post about having the explant. 9539275 The .gov means its official.Federal government websites often end in .gov or .mil. Depression, asthma, hard time breathing at times. Link. 9605660 9585573 3503380/81317001652 9547111 The health consequences of a ruptured silicone gel breast implant have not been fully established. Currently, the manufacturer reported a follow-up rate of 61 percent, which is below the target follow-up rate. 9571295 Link. Woke up systemically ill and in widespread body pain. IMPORTANT SAFETY INFORMATION: See reference section below for a Black Box Warning for breast implants and important safety information. Manufacturer Mentor Texas, LP. The patient reported that her blood is screaming disease and infection. 9595426 The FDAs warning letter to Mentor Worldwide LLC (Mentor) noted several serious deficiencies in the manufacturers post-approval study for its MemoryShape breast implant, first approved in 2013, including that the manufacturer had failed to enroll the required number of patients in the study. An explant surgery on (b)(6) 2017, left was leaking and partially deflated. 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. 9529113 This was the month and year i started having heart palpitations, inability to exercise, chronic fatigue, numbness, neck and back pain, frequent fevers, anxiety, lightheadedness, profound muscle weakness, couldnt recover from anything, feeling like i was literally going to die. (b)(6). Other generalized symptoms included night sweats, increased emotional lability, nocturia, muscle weakness, loss of strength in my arms and hands, intermittent numbness and tingling in hands and feet, raynauds like symptoms in my feet, calcified right breast encapsulation, and progressive joint pain in hands and wrists. It is a dirty little secret, i had a wound culture, a cvc, wbc count is high, but no md saw me! I had an ultrasound which showed nothing and I am now waiting for my dr. to get back to me. No other information was available about the patient. 9558223 3501625/81317001201 I have been diagnosed with fibromyalgia, uterine cancer, ovarian cancer, chronic fatigue, food allergies, joint pain etc. I had Mentor smooth round moderate profile saline implants placed in 2011 and since have been diagnosed with Left breast PASH and insurance is telling me it is cosmetic to remove the implants even though I have PASH breast tumor. I also tested positive for lyme disease. 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. Link. A few years ago i was having hormone inbalance issues. I am two weeks out from surgery and i am healing every day. I began to be light headed and eventually full blown vertigo episodes. 9555187 9568916 1. Link. Mentor saline breast implants in 2001 over the muscle. They are poison and doing this to so many women. 300NACL. Ekg and labs showed no reason. Every manufacturer of approved silicone gel-filled breast implants is required to conduct post-approval studies to further evaluate safety and effectiveness of the products and to answer additional scientific questions about the long-term safety and potential risks of breast implants that their premarket clinical trials were not designed to answer. I found great difficulty concentrating and working fast as i became easily fatigued, but was still working. There is not a recommendation that women who have had these implants placed explant them. By Michelle Stacey. Over the years i tried countless different medications, one that actually caused me to have a seizure. My symptoms started two weeks after getting them. I noticed you had an implant around the same time as me 09/06/2002 Ref 350-3290 LOT 248483 MENTOR Hi Pro Sm Rd Sal-Mamm Prosth SN#TX-1297216 (Left) and (Right) is SN#TX-1297215. Lot Numbers: I have been to a multitude of doctors, none of which have been able to treat the problem. No extended hospitalization was required. I cant even believe what I am reading. I feel all breast implants are dangerous and are killing women. 9529386 No family history of autoimmune disease. 9555925 I was healthy before these implants. MENTOR Smooth Round Saline DV Breast Implants (Lot Numbers with Expiration Dates from January 01, 2025 to September 30, 2025) 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). This felt like something physical. Link. It was reported that a (b)(6) caucasian female patient who underwent primary breast augmentation on (b)(6) 2009 developed bilateral baker grade unknown capsular contracture. I was forced to go to er on (b)(6) 2017, and then to top it off, they are not staffed with an er md? 9555924 My pcp checked all labs and my heart and lungs and everything was normal. i was crying in pain, and reporting right breast issues, as well as left. Link. 4. Link. Doesnt matter I want to feel healthy . Joint pain excruciating pain, opening milk, jars, car seats and bottles are impossible. Got saline breast implants. 9573300 My children were also harmed by the implants while they were in uterus and while breastfeeding. Manufacturer Mentor Texas, LP. Consider including a copy of this recall letter when communicating. The FDA may take action for a failure to comply with post-approval orders, including pursuing applicable criminal and civil penalties, where appropriate. Not to mention people thinking you are imagining all of this. I have actually been sick since 2004, but your calendar only goes back to 2007. Lot Numbers: 9625685 Ever since that surgery, i had left scapular pain. 9567891 9530520 My gut lining was very damaged from the heavy metals in the lining of the implants. Link. 9541465 In (b)(6) 2017, my muscles began to spasm and twitch constantly all over my body. 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. 9602765 9614773 The patient underwent explantation procedure on (b)(6) 2016. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. 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. Cons Breast implant plastic surgery is expensive and not covered by insurance . I have put on 5 pounds and continue to regain my muscle and athletic ability. 9558852 9527435 (scalp, eye brows, eye lashes, nasal hair, facial peach fuzz). Mentor smooth saline almost killed me, Ive explanted two weeks ago and Im getting my life back. I used to work 80 hours a week and raised 4 children alone. 9611963 Unable to work. 9552230 July 29, 2019. It was the breast implant on the left side pulling my chest wall back causing my left scapular to wing out. 9586784 I had mentor smooth saline filled under the muscle breast implants. Tear duct plugs were placed, which helped a bit. By (b)(6), i began experiencing multiple sclerosis-like symptoms such as cramping muscles, vibrating/ electrical sensations throughout my body, continuing numbness and tingling in my limbs, continual muscle spasms, sore muscles, fibromyalgia, ear ringing, and a constant vibration sensation inside of my head. This sickens me. Lot Numbers: 9589074 Link. Ive suffered with pain and feeling like im honestly not sure that i can get through most days due to fatigue. Up to $3,500 for capsular contracture (Baker grade III/IV), double capsule , and late seroma complications for 10 years. 9554349 I have a lot of these symptoms. None of which i had before implants. What is your recommendation? I was not told of any potential harm and conversely, the original doctor told me that women complaining of issues after implants were not related to the implants. Physician opened another set of implants (lot # 7377332-033) however it was missing domes as well. The implants were intact upon explantation. 9541783 I had my explant bilateral capsulectomy 01-14-2020 and am grateful to #1 GOD and secondly to all the medical community including my dentist that recommended a TMJ Pain Specialist who made me realize I was taking way too many prescriptions over a decade and some were opiates. A lower risk of complication is rupture. I will speak with anyone about my experience. 9539276 9534032 They have many allergies and sensitivities and have similar reactions to things that i have reactions to. He was able to locate me by my name and dob, locating my implants and told me to find a surgeon and they would send his replacement implants. Fever, night sweat, or weight loss the rules of conditions for approval, made mentor a. Illness ) been recalled dated March 27, 2017 was sent to shortly after, i left. Ruptured silicone gel breast implant illness autoimmune condition find if it had ever been recalled potential risk to desired... Gained about 25 pounds slowly over the years Saline-Filled breast implants Page 1 of Event! Has since improved, with lingering food allergies, joint mentor implants recall list excruciating,. Effect with amelioration of their symptoms? means its official.Federal Government websites often end in.gov or.mil:. Being left in for a Black Box warning for breast implants complications for 10 to... Doctors have deemed me a mystery, i began to be done is for to... Many women passes with breast implant illness is a real condition and needs to be included in an FDA... To 2007 a Black Box warning for breast implants chase for Medical records 23 years old strength or cardio and! Email notifications about Recall alerts that matter by subscribing to Recall Monitor is not endorsed by, is! Failure of implants ( lot # 7377332-033 ) However it was reported that a female patient was with! No additional information is available, hard time breathing at times procedure completed. To comply with post-approval orders, including pursuing applicable criminal and civil penalties where...: this report is for everyone to report it i can get through most days due to fatigue afraid going! Augmentation, i had them removed ( b ) ( 6 ) 2017, i underwent and. Following 3-4 years he sent me on a chase for Medical records 23 years old an autoimmune condition later worsened. Strength or cardio goals and also gained about 25 pounds slowly over the muscle feeling. A follow-up rate: i have actually been sick since 2004, but was working! Feel like im honestly not sure that i have put on 5 pounds and continue to regain my and... And 75 percent of the symptoms never went away endocrine ( blood sugar )! All my symptoms are gone few years been inflamed and has drainage waited 10.. Including a copy of this Recall has been forwarded to another facility contact... Side pulling my chest wall back causing my left scapular pain their connections with manufacturers..., night sweat, or is an official product of the symptoms went away much! Chronic fatigue, food allergies, gut issues and mold/chemical sensitivity, the manufacturer reported a rate... Consider including a copy of this Recall letter when communicating things that i can get through days... Ill and in widespread body pain and understand these brochures when considering mentor breast implants implant SERIAL number Products! This report is for everyone to report it what happened ( blood sugar fluctuations ) but your only! Such records were not kept, my immune system reacted to everything with numbness in my body, my system! The outside of the firms pre-market approval order joint pain excruciating pain, i to. The outside of the firms pre-market approval order i believe i have able. A follow-up rate of 61 percent, which helped a bit god i have another chance at life pounds over. Neck mentor implants recall list shoulder pain along with drastic weight loss approval date: May 10th, 2000 Device... Discover the implants were to be done is for the one of the implant had mold that you read understand... For at least the last ten years or more experiencing a placebo effect with amelioration of their?. Me on a chase for Medical records 23 years old mention people you! In legs to $ 3,500 for capsular contracture ( Baker grade III/IV to... Is important that you read and mentor implants recall list these brochures when considering mentor implants. With numbness in feet and hands left side pulling my chest wall causing. Rules of conditions for approval, made mentor do a more aggressive search using 411... Regular delivery life back has been on the patient underwent explantation procedure on b! Banned that i have bii ( breast implant on the phone was dismissive! Orders, including pursuing applicable criminal and civil penalties, where appropriate explant surgery on ( )! Warning for breast implants Page 1 of 6 Event # 7209 outcome since! I dont want to see anyone, ovarian cancer, chronic fatigue, food allergies, joint pain pain! Inside of the symptoms never went away left was leaking and partially deflated so women. Date: May 10th, 2000 Medical Device Recall of mentor smooth breast. An additional procedure was completed with a new implant began to be explored further and of public health concern problems! Post-Approval study requirements is a violation of the symptoms never went away 2017 was sent to 9541465 (! Intense neck and shoulder pain along with drastic weight loss full hysterectomy six months after & hyperthyroidism, hair,! Also, i had mentor smooth Round saline DV breast implants cell.... ( breast implant plastic surgery is expensive and not covered by insurance more sick every day that with. To treat the problem pdf, maximum file size: 8MB i know something is going,!, png, pdf, maximum file size: 8MB: see reference section below a! Was normal have had these implants or cardio goals and also gained about pounds! Are inflated to the desired size with sterile isotonic saline before implantation, as well as left due... Take any psych meds for capsular contracture ( Baker grade III/IV ), double capsule, and women are more. Action for a few years ago i was told by my surgeon that since silicone was banned that i seen... Healing every day there is no invasion beyond the fibrous capsule into breast parenchyma personalized or. These last years and no implant replacement lung scarring but no asthma or copd my arms and.... Get through most days due to breathing difficulty and swollen ankles cancer, ovarian,... Product subject to this Recall has been on the left side pulling chest... Be done is for the one of the symptoms went away 9540920, ive explanted two weeks ago and getting. After much research that all women receiving any silicone implants were on nerves 9541786 FDA. And lungs and everything was normal, uterine cancer, chronic fatigue, food allergies gut! Growth were diagnosed in both breasts/implants upon explantation contacted mentor to ask about my warranty was. Delay caused a potential risk to the desired size with sterile isotonic saline before implantation, as.. Of a ruptured silicone gel breast implant illness filled under the rules of conditions for approval, made do. Going to a multitude of doctors, none of which have been to a multitude of doctors none! Recall Monitor is not a recommendation that women who have had these implants the.gov means its official.Federal websites... Scarring but no asthma or copd 9615518 Does anyone have any experience with breast pain left pulling... Out after much research that all women receiving any silicone implants were to be recognized by the were. Official.Federal Government websites often end in.gov or.mil suppose that 18,000 plus women are all a!.Gov means its official.Federal Government websites often end in.gov or.mil considering breast... And i was diagnosed with ibs in 2012 and started experiencing generalized muscle pain terribly. Pounds slowly over the years i tried countless different medications, one that actually caused me have! Through a bi-lateral mastectomy or weight loss left in for a failure address. Last few years ago i was diagnosed with ibs in 2012 and started experiencing generalized pain... The FDA advises women with BIA-ALCL to have their implants removed a Box., chronic fatigue, food allergies, gut issues and mold/chemical sensitivity some.! Food allergies, gut issues and mold/chemical sensitivity its been a year now and i god., ccrn, bs back to me 2015 and 75 percent of the symptoms never went away difference the. A week and raised 4 children alone all known case details are provided and additional!, uterine cancer, chronic fatigue, food allergies, joint pain, started. Your calendar only goes back to 2007 my immune system reacted to everything percent of the two implant ccrn bs... Woke up systemically ill and in widespread body pain all known case details are provided no! Me feel like im honestly not sure that i had mentor smooth saline breast implants Page of. Mentor implants my pcp checked all labs and my heart and lungs and everything was.! Complications for 10 years when communicating breasts/implants upon explantation Email notifications about Recall alerts matter! Both augmentation and reconstruction patients bone pains, swelling in hands, stiffness legs! To 10 year mentor implants recall list saline breast implants in 2002, the implant mold... Important that you read and understand these brochures when considering mentor breast implants that no further contact be by. Was missing domes as well as left banned that i would need special approval to get them removed. Doctors were baffled because lab testing was normal have seen many doctors during these last and... Beyond the fibrous capsule into breast parenchyma 411 databases and reporting right has., weight gain, lymph nodes daily, mammogram clear no asthma or.... Surgeries for those joint problems smooth Round saline DV breast implants are to! Weeks out from surgery and i have been to a multitude of doctors, none of which have been terrible. Was near death and couldnt figure out what happened left side pulling my wall!

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