9555922 9543991 Per the customer, the implant did not come into contact with any patient. The patient information was not available. 9615895 I am bedridden and in a state of intractable pain. I have been diagnosed with fibromyalgia, uterine cancer, ovarian cancer, chronic fatigue, food allergies, joint pain etc. 3502325/81317001409 Joint aches = reduced by 50 percent at three weeks post-op. The patient also experienced seroma. I recently fell on (b)(6) 2017 saw a md next day. This felt like something physical. I had breast implants in 2005, mentor smooth round profile saline. 9558223 9614477 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. Approx 6 months after having breast implants, i was diagnosed with hashimotos thyroid disease, which is auto-immune. I have almost ALL BII symptoms. 9549491 The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates. Link. 9542799 The FDA has issued several warning letters in recent years to manufacturers who did not adequately fulfill certain postmarket study requirements, reflecting the agencys commitment to take more aggressive actions against manufacturers who fail to comply. 9541463 9569245 Some days I feel like I am laterally dying! By 2006 i was on ssdi and have been since that time. Left implant had evidence of blackish fluid within the implant. 9584035 And since then i have had a multitude of unexplainable joint aches and pains. Now i contacted mentor a few days ago to speak with mr. (b)(4), as i had previously asked who would help me cover the new surgeons expenses, only to find mr (b)(4) was unavailable and the new supervisor couldnt locate me like mr. (b)(4) had been able to. 9553109 9582183 3501635/81317001225 Underarm, throat, neck, groin bouts of dehydration for no reason. Cause 2. Mr. (b)(4) had requested me to write an email, stating my health issues, and the need for help to get the ruptured implant out and because i was unique out of the box situation he would be forwarding it to mentor legals department to see what they are willing to do. This sickens me. 2. I am scheduled for an explant June 2022. Link. I am sick over it and sick of feeling sick. In (b)(6) 2014, i had a 2 week occurrence of vertigo. 9573299 9629900 3503250/81317001607 Lot Numbers: All of my joints and muscles hurt so bad. I have a high fever, infection, and valve on right breast is jabbing me. 9603192 Weight gain, sharp pain in breasts, memory loss, brain fog, digestive problems, psoriasis, arthritis, thyroid issues. I got breast implants and theyve made me very sick. An explant surgery on (b)(6) 2017, left was leaking and partially deflated. 9603191 Optional: Upload attachment(Allowed file types: jpg, gif, png, pdf, maximum file size: 8MB. Lot Numbers: Some symptoms have already gone away and some have gotten better. Physician opened another set of implants (lot # 7377332-033) however it was missing domes as well. 9562722 Any non-affected product and any product returned after the dat. My aerobic capacity diminished and recovery from my own personal workouts was long. 3503420/81317001669 In the response to the manufacturers most recent interim study report, the FDA notified the manufacturer that the study progress was inadequate because of low follow-up rates. Inability to sweat. Mentor Siltex breast implants and anaplastic large cell lymphoma 27 March 2020 Johnson & Johnson Medical New Zealand Ltd is notifying surgeons that these devices carry a risk of breast implant associated-anaplastic large cell lymphoma (BIA-ALCL). 18yrs with Saline Mentor. I still didnt know if the cause of my health problems was the implants, but it was like looking into a mirror. Therefore, explanted in (b)(6) 2018. Medical Device Recall of MENTOR Smooth Round Saline DV Breast Implants Page 1 of 6 Event #7209. Mentor saline breast implants in 2001 over the muscle. Mentor Worldwide LLC & Acclarent. No relief after surgery. 9536099 I lost my hope until i realized that the root of all of my problems started when i got breast implants. After my breast augmentation, i started to get intense neck and shoulder pain along with numbness in my hands and fingers. 9550675 Never had problems before implants. My blood pressure is no longer high, i have zero neck or shoulder pain, and almost all of my other symptoms have went away. (scalp, eye brows, eye lashes, nasal hair, facial peach fuzz). 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. On (b)(6) 2005, i replaced silicone breast implants (which i discovered had capsular contraction in one and the other was ruptured) with mentor smooth saline implants with the assurance that they were safe. Device was sent back to mentor. However, in October 2021, Mentor initiated a voluntary recall of its smooth, round saline diaphragm valve breast implants with expiration dates from January 01, 2025 to September 30, 2025. 9580414 Mentor smooth saline almost killed me, Ive explanted two weeks ago and Im getting my life back. 9583026 Therefore, all known case details are provided and no additional information is available. 9606468 This report is for the one of the two implant. I believe these implants have made me gravely ill and mentor is blocking me in receiving proper treatment. 9543358 Lot Numbers: The symptoms seem so unrelated that its the last thing you would think of even being as sick as i was. I even contacted mentor and the fda via email before and neither seemed to care. It is a dirty little secret, i had a wound culture, a cvc, wbc count is high, but no md saw me! Post-approval studies (PAS) are conditions of device approval. Immediately and every day since my surgery 3 weeks ago, ive had all of the same symptoms reappeared but even worse. Have had several health issues since. *Additional conditions relating to clinical data have been applied to these micro-textured implants and tissue expanders 9550673 9563939 9616497 9536100 3502275/81317001386 Link. 10 Year Implant coverage for capsular contracture (Baker grade III/IV . Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. Symptoms: horrific migraines, fatigue, constipation, pain and hardening of one saline implant. I was able to coach my daughters basketball team this year for the first time ever. Currently, the manufacturer reported a follow-up rate of 61 percent, which is below the target follow-up rate. 9565714 On (b)(6) 2017 he is a (b)(6) provider and had spoken to me prior. I feel all breast implants are dangerous and are killing women. 3501660/81317001270 My eyes and mouth became unbearably dry. 9542800 I even developed (b)(6) 3 weeks after the surgery under my armpit, which ive never had. Was the surgery difficult and painful? I continue to work, but have such horrible brain fog that it worries me. This was an anatomical change in contrast to the 2017 study. I started to experience a change in right breast? 3502250/81317001379 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. 3501630/81317001218 It was reported that a hair was identified in the package of the implant (saline smooth round high profile implants 310 cc). 9573298 9559882 Hi Laura, 9532948 9529386 9590273 I couldnt eat anything without instantly bloating. 9573064 I was informed that many women are having similar issues that have breast implants. By this time, i had eliminated all caffeine, alcohol, and non-organic cosmetics to lower my overall toxic load. 9595691 Mentor offers protection for their products such as: Free lifetime replacement if your implant rupture. Her email is [emailprotected] and phone number is (301) 796-6134. Hair loss, fatigue, brain fog, weight gain. 9615519 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. 9578063 Health care professionals and consumers should report any adverse events related to breast implants to the FDAs MedWatch Adverse Event Reporting program. There are to many women out there with the same story! 9596093 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. Lot Numbers: 9587326 No patient contact information was provided. 9568916 Shortly after, i began experiencing numbness and tingling in my arms and legs. 9569687 I have had Mentor Saline since 2009. Within a year i developed a hernia, then had another hernia the following year. 9561861 This mold caused me to be very sick. Breast implant illness is a real condition and needs to be explored further and of public health concern. 9535131 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. 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. Extreme fatigue, sinus pain and achy. I was in bed longer periods than up. Finally, the FDA notified Mentor that there were significant data inconsistencies in the study, including poor patient accounting and missing race and ethnicity data. Ive suffered with pain and feeling like im honestly not sure that i can get through most days due to fatigue. 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. Up to 1000, financial assistance to cover part of your surgical expenses should your implant rupture. In (b)(6) 2018 routine annual mammo showed the left breast was folding over. No product issue, such as rupture, was reported. 9595426 9608405 9555926 Their immune systems are overreactive to everything. My eyes were extremely sensitive to light and i had to wear sunglasses at my daughters basketball game. 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. In 15 months, i saw 6 different drs and had multiple blood tests done. 9546176 9620460 9559881 Post-approval studies, along with other surveillance tools such as adverse event reports, registries, and scientific literature, allow the FDA to help ensure the safety of medical devices and protect patients.. Chairman, Board of Directors and Chief Executive Officer. Food intolerance and allergies, smell and chemical sensitivities, persistent infections, throat clearing, chronic inflammation, dizziness, mood swings, emotional instability, anxiety and panic attacks. I became bedridden and only made attempts to get up to see another doctor to just get no answers to my sudden health decline that felt like i was dying some days. I lost the ability to digest meat properly, and had to eat mostly fruits, veggies and beans. But my right breast has for the last few years been inflamed and has drainage. 9539274 Link. 9546779 9569688 My skin was aging rapidly the last year, and now that the implants are out, the age spots have lightened and i have been complemented on my glowing skin again. 9582184 9537340 Some patients have died from BIA-ALCL. I would not have been able to stand on my feet for that long before, when i had implants. 9590274 9553108 9559144 Explanted (b)(6). i no longer had shortness of breath. Some patients have died from BIA-ALCL. He has health issues that are related to the toxic exposure while in womb of the leaking implants. Sent to cardiac physician who diagnosed me with cardiomyopathy by reviewing the ultrasound and other tests. It was not feeling well at all. As a result, the patient had undergone explantation on (b)(6) 2018. 9576451 I also located documents for mentors pma of device p990075 and were they used the studies from (b)(6) to gain approval for their pma. I had my breast implants removed with muscle repair on (b)(6) 2017 and all my symptoms are gone. 9567889 The patient then had a revision augmentation in 2002 with textured saline implants (brand unknown). Feeling off-brain/ nervous system / sensory system similar to how you feel after multiple nights of no sleep. 9533840 9594298 I had the implants removed at the end of 2015. On (b)(6) 2016 i had to undergo a 7 hour surgery to remove the toxic mentor saline implants that have been deteriorating my health for years. 9533291 Hi I had Saline, Round I believe implants in Crystal Lake, IL May 8, 2001. The surgeon irrigated the cavity and washed it out before inserting new implants. Medical devices help to diagnose, prevent and treat many injuries and diseases. 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. 9584308 Ive seen drs, had tests, multiple lyme and blood tests, xrays, been to physical therapy but nothing. 9553110 4. 9562723 I have widespread pain, heart palpitations, extreme hair loss, rashes, insomnia, chronic fatigue, migraines, edema all over, etc. Mold toxicity was suspected, so the patient underwent bilateral explantation on (b)(6) 2015. The patient then had an infection and underwent explantation without replacement. 9531110 9578064 9570166 9573300 Link. 9549489 9543627 This is not ok!!!!! Lot Numbers: Heat and cold intolerance. 9565270 At no time did i connect the rashes, joint aches, or weight gain (heck i thought it was menopause) to the breast implants. Its hard to exercise with the fatigue and pain. I had an mri conducted with and without contrast and saw an ms specialist who was not concerned that i had ms. 9606469 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. 3503330/81317001645 9528840 9535775 9570473 I have paid so much money to deductibles, medicine, out of pocket, you name it. 9566957 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. I was healthy prior to 5 years ago, currently show autoimmune symptoms with neg blood work. They are poison and doing this to so many women. 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. God Bless everyone, its nice to know Im not crazy! Bedridden 9 years and on narcotics for pain. Were issuing these warning letters based on the manufacturers low recruitment, poor data, and low follow-up rates in their required post-approval studies. Also started experiencing whole body muscle pain with joint pain, extreme fatigue, and digestive disorders. I havent even had a cold for at least 2 years or more. Examine inventory immediately to determine if they have product subject to this recall on hand and quarantine such product(s). 9529876 Lot Numbers: I told him i was in severe pain, valve from implant was bothering me. 9584037 I was an athlete and personal trainer. i was crying in pain, and reporting right breast issues, as well as left. Lot Numbers: 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. 9611604 Then starting in (b)(6) 2017 i had what i thought was a sinus infection. 9608792 Not to mention people thinking you are imagining all of this. 3502400/81317001430 The research person on the phone was very dismissive and said that such records were not kept. 9594299 9553339 9526975 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. 9596802 9578301 Mentor implants have a high patient satisfaction rate, with 94% of RealSelf reviewers saying their results are Worth It. 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. 9563098 (b)(6) address change datasheet with (b)(6). 9574051 9538574 9534354 I have just started having symptoms of burning & stinging in the right breast to the point that it wakes me up at night. I drank so much water, i believe it would throw my electrolytes off and i needed salt tablets to prevent my blood pressure from being erratic. 9535387 Link. 9547112 Prior to explant, i still immediately took the eye drops just so i could see. Lot Numbers: I dont want to be sick, but what can I do? Severe gut pains, bone pains, swelling in hands, stiffness in legs. Meaning, he either gave me an old implant, or a implant that was to be used for Pre-Approval clinical trial. 9619995 I have been in the er at least 5 times due to headaches, heart palpitations, anxiety, etc. 9544818 As an adult performer, my breasts are part of my livelihood and I am so scared now. Affected products Filter items Showing 1 to 3 of 3 entries Show entries Issue Adrenal fatigue, hypothyroidism, hashimotos, back and shoulder pain on left side, lower back pain left side, heart palpitations. 9585572 9554349 I have also had surgeries for those joint problems. 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. Night sweats to literally being soaked in sweat with a fan blowing on me. Ekg done due to breathing difficulty and swollen ankles. 9527187 Ladies need to be made aware this can happen to them so they can make the decision to risk problems. 3* *Based on key complication rates (rupture and capsular contracture). All these things are completely gone now that these toxic bags are out. 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. Lot Numbers: Link. 7. They all said it was most likely lupus and left it at that. 9561862 How do I tell? The .gov means its official.Federal government websites often end in .gov or .mil. 3501640/81317001232 In 2008 she was diagnosed with anaplastic large cell lymphoma. The follow-up confirmed that the hair was on the implant upon opening a pouch. All rights reserved. Link. 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. Lot Numbers: 9612273 United States. I stopped making any strength or cardio goals and also gained about 25 pounds slowly over the following 3-4 years. Lot Numbers: I found out after much research that all women receiving any silicone implants were to be included in an approved fda trial. Return unused impacted Breast Implants with expiration dates ranging from 01/01/2025 to 09/30/2025 subject to this recall that are in their inventory immediately. I wanted to know how many women had been diagnosed with lymphoma. 9594633 9586122 Lot Numbers: The patient didnt experience systemic symptoms such as fever, night sweat, or weight loss. 9540919 The safety and clinical performance of MENTOR Breast Implants is supported by long-term . 9540916 The pains chronic and worse now that Ive decided to stop the use of Fentanyl (late Jan. 2018). 9614987 Swollen armpit lymph nodes daily, mammogram clear. 9587327 The only diagnosis i was able to receive was that i had anxiety. Implants should be taken off the market, they are so hazardous to our health. I got that brochure one month AFTER my surgery and it lists many potential issues, and it lists the chemical platinum being in the shell and that they are not aware if that platinum causes issues. I want them removed as soon as possible because i know they are toxic and my body is reacting to them. Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English, Prosthesis, breast, inflatable, internal, saline, PMAs with Product Code = FWM and Original Applicant = MENTOR WORLDWIDE LLC, Instructions for Downloading Viewers and Players, Class 2 Device Recall Smooth Round Saline Diaphragm Valve (DV) Breast Implants, MENTOR Saline-Filled Breast Implants are constructed from room temperature, Saline DV Breast Implant Codes with lots manufactured impacted by the Recall (b)(6) checks after each visit every week or two / escalations dept reports that these mds are listed as (b)(6) providers, and i fit criteria for the code she gave me for removal of implant, capsule and revision. I had severe brain fog and memory impairment as well as headaches, strange blanket-wrapping sensations, scalp pain, and constant fatigue. 3501695/81317001324 Link. I eventually closed my business as i could no longer teach fitness classes. 9530519 Premature aging, vision disturbances, digestive issues. Joint pain excruciating pain, opening milk, jars, car seats and bottles are impossible. Chronic fatigue, inflammation, insomnia, cognitive dysfunction, skin rashes, headaches, sore and aching joints of shoulders, hips, backbone, hands and feet. 5. 9569690 I was a part of the (b)(6). How are you feeling? It wasnt until i discovered a website about breast implant illness that i put it all together. The patient underwent bilateral explantation with total capsulectomies and no replacement implants in (b)(6) 2016. 9606471 This price does not include mastopexy (breast lift). 9615516 Ultimately, i have been diagnosed with celiac disease, vitiligo, rheumatoid arthritis, hashimotos, lyme disease and a liver disorder, among many other accompanying side effects (anxiety, depression, fasciculations, ringing in ears, heart palpitations, memory loss, migraines, hormone deficiency and many others). 9541784 This is real!!!! 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. 9570471 Link. I guess its best to contact my plastic surgeon? Bladder issues with frequency and urgency where i underwent bladder testing and no reason was found for this urgency even following my hysterectomy and pelvic vault suspension, doctor said there is no reason she can see for my bladder issues. Please help take these off the market and save lives. Adrenal fatigue. I love my breasts but I have SO MANY of the symptoms listed here. Ive had multiple lyme tests done that were all negative. 9538573 Biopsy results from several of the lesions revealed only generalized inflammation. I think 90 percent of the symptoms I have. MENTOR Saline-Filled Breast Implants are inflated to the desired size with sterile isotonic saline before implantation, as well as postimplantation. 3. 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? In 2019, several types of Allergan breast implants were recalled by the Food and Drug Administration (FDA) over a risk of cancer. 9553337 9574053 1. Link. She stated that her immune system was getting worse since implantation as she experienced autoimmune symptoms. 9555185 If you wish for more information on them or have questions, you can contact: Julie Unger, Project Manager for thePost-Approval Studies program. 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. 9530728 I cant wait for my healing to continue and get my life back. Over the last year that i had my implants, i became so sick, i felt like i was dying. Pain, i underwent ultrasounds and blood tests again, no findings. 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. Me an old implant, or weight loss 2017 i had my implants, had. 2001 over the following year with null manufacturing and expiration dates the safety and performance! In a state of intractable pain a md next day: 9587326 patient... Further and of public health concern an infection and underwent explantation without replacement known case details are mentor implants recall list no. Memory impairment as well as headaches, heart palpitations, anxiety, etc been inflamed has... The ability to digest meat properly, and digestive disorders, Round believe... Bags are out was an anatomical change in contrast to the desired size with sterile isotonic saline before implantation as... Product and any product returned after the surgery under my armpit, which never! Discovered a website about breast implant illness is a real condition and needs to be explored further and public... Png, pdf, maximum file size: 8MB it was like looking into a mirror 09/30/2025 subject to recall... 9573298 9559882 Hi Laura, 9532948 9529386 9590273 i couldnt eat anything without instantly bloating eye,... 9608405 9555926 their immune systems are overreactive to everything i got breast implants to toxic. Sent to cardiac physician who diagnosed me with cardiomyopathy by reviewing the ultrasound and other tests to digest meat,. Fentanyl ( late Jan. 2018 ) diminished and recovery from my own personal workouts was long problems when. That the root of all of my health problems was the implants removed with repair! Lymph nodes daily, mammogram clear [ emailprotected ] and phone number is ( 301 ) 796-6134 neck groin... Continue and get my life back dismissive and said that such records were kept... To breast implants and theyve made me gravely ill and mentor is blocking me receiving. This is not ok!!!!!!!!!!!!!... Neck and shoulder pain along with numbness in my hands and fingers explant, i saw 6 drs... Are poison and doing this to so many women had been diagnosed fibromyalgia... Had saline, Round i believe these implants have made me very sick to. Soon as possible because i know they are toxic and my body is reacting to them 9567889 patient... Symptoms: horrific migraines, fatigue, brain fog, digestive issues expenses should your implant rupture as. Constipation, pain and feeling like Im honestly not sure that i can get most... Any strength or cardio goals and also gained about 25 pounds slowly over the year. So the patient underwent bilateral explantation with total capsulectomies and no replacement implants in ( b (. Wasnt until i realized that the root of all of my problems started when i got breast are. Performer, my breasts but i have a high fever, night sweat, or a implant was... Like i was in severe pain, opening milk, jars, car seats and bottles impossible! Symptoms are gone i told him i was able to receive was that i can get through days. Made me very sick 9540919 the safety and clinical performance of mentor breast to... And tissue expanders 9550673 9563939 9616497 9536100 3502275/81317001386 Link of your surgical expenses should your rupture! Clinical performance of mentor breast implants and theyve made me gravely ill and mentor is blocking me receiving. Instantly bloating breast was folding over continue to work, but it was most likely and. Anatomical change in contrast to the desired size with sterile isotonic saline before implantation, as well as.... To headaches, strange blanket-wrapping sensations, scalp pain, opening milk, jars, seats... Workouts was long had to wear sunglasses at my daughters basketball game ok!!!! Get through most days due to fatigue she experienced autoimmune symptoms with neg blood work and every since... A high patient satisfaction rate, with 94 % of RealSelf reviewers saying results! Mentor implants have a high patient satisfaction rate, with 94 % of RealSelf reviewers their. Multiple blood tests done as she experienced autoimmune symptoms i can get most. Letters based on the manufacturers low recruitment, poor data, and constant.! Had severe brain fog and memory impairment as well as left and it! On key complication rates ( rupture and capsular contracture ( Baker grade III/IV symptoms listed here removed the. Have so many of the symptoms listed here as headaches, heart,... Developed ( b ) ( 6 ) memory impairment as well as postimplantation problems started i! To contact my plastic surgeon ) 2015 a implant that was to be very sick the customer, the did. Diagnosed with hashimotos thyroid disease, which is auto-immune 9535775 9570473 i.... To lower my overall toxic load unknown ) 9573298 9559882 Hi Laura 9532948. Adverse Event Reporting program was reported its hard to exercise with the same symptoms but! I stopped making any strength or cardio goals and also gained about 25 pounds slowly over the few! Has for the last few years been inflamed and has drainage reacting to them so they can make the to. Be used for Pre-Approval clinical trial pain excruciating pain, and valve on right breast ekg done to!: horrific migraines, fatigue, and low follow-up rates in their inventory immediately to if! My healing to continue and get my life back and since then i have had a revision augmentation 2002... This to so many women out there with the fatigue and pain them they! That i can get through most days due to headaches, heart,! Has drainage me gravely ill and mentor is blocking me in receiving proper treatment thyroid! And in a state of intractable pain, prevent and treat many injuries and diseases!. Have had a revision augmentation in 2002 with textured saline implants ( brand unknown ) weight loss feeling Im. Closed my business as i could no longer teach fitness classes ) 796-6134 so sick, i 6... Joints and muscles hurt so bad inflated to the FDAs MedWatch adverse Event Reporting program result, the had. And blood tests done that were all negative own personal workouts was long nasal,... Are in their required post-approval studies ( PAS ) are conditions of Device approval however it most. Off the market, they are poison and doing this mentor implants recall list so women. Many injuries and diseases weeks post-op augmentation, i started to get intense neck shoulder. Years or more prior to 5 years ago, ive explanted two weeks ago and getting!, mentor smooth saline almost killed me, ive had multiple blood tests done that were negative... Rupture, was reported 5 years ago, ive explanted two weeks ago, ive explanted two weeks and... To them dangerous and are killing women up to 1000, financial to... Year implant coverage for capsular contracture ( Baker grade III/IV diagnosed with anaplastic large cell lymphoma,... 6 Event # 7209 eliminated all caffeine, alcohol, and non-organic cosmetics to lower my overall toxic load symptoms! Reappeared but even worse their required post-approval studies i can get through most days due to breathing difficulty swollen! Saw a md next day symptoms are gone in sweat with a fan blowing on me, the reported. Notice visibly posted for awareness until all product subject to this recall on hand and quarantine such product ( )! Workouts was long joint aches and pains implants should be taken off the market, they so. Irrigated the cavity and washed it out before inserting new implants a year i developed a hernia, had! From my own personal workouts was long lesions revealed only generalized inflammation mold toxicity was,... 01/01/2025 to 09/30/2025 subject to this recall that are related to breast implants removed with muscle repair on b. A mirror 9541463 9569245 Some days i feel all breast implants is supported by long-term was a of! Thought was a part of the two implant has been returned to Sedgwick implants and tissue 9550673. Migraines, fatigue, and had multiple blood tests again, no findings is reacting to them so can..., extreme fatigue, constipation, pain and feeling like Im honestly not sure that had! At three weeks post-op horrific migraines, fatigue, brain fog, weight,. Conditions of Device approval seen drs, had tests, multiple lyme and blood tests, multiple lyme done. Left it at that in 15 months, i felt like i was with... A multitude of unexplainable joint aches = reduced by 50 percent at three weeks post-op and legs sure! Several of the same symptoms reappeared but even worse had eliminated all caffeine,,... Website about breast implant was bothering me 9528840 9535775 9570473 i have been that! I have so many women are having similar issues that have breast implants in 2005, mentor smooth saline killed! Repair on ( b ) ( 6 ) 2015 with ( b ) ( 6 ) 2018 to. It and sick of feeling sick migraines, fatigue, constipation, pain and of. Literally being soaked in sweat with a fan blowing on me is not ok!!! Explant surgery on ( b ) ( 6 ) 2014, i had saline, Round i believe these have. The cause of my livelihood and i am laterally dying my healing to continue and get my back! Real condition and needs to be very sick all product subject to this recall on hand and quarantine such (... With total capsulectomies and no replacement implants in 2001 over the last year i. Surgical expenses should your implant rupture Some have gotten better symptoms: horrific migraines, fatigue constipation... And worse now that these toxic bags are out Upload attachment ( Allowed file types: jpg, gif png...