Skin issues were addressed with various creams/meds, none which resulted in improvement. (Unknown if it is Mentor saline or silicone). The patient sought treatment from several physicians, who concluded that the implants were responsible for patients condition. Her face started to swell when she got cold. All rights reserved. My body couldnt sweat couldnt get rid of toxins. Wrong! 350-2250 I was healthy and active prior to breast implants. MENTOR MemoryGel Breast Implants, MENTOR MemoryShape Breast Implants, and MENTOR Saline-filled Breast Implants are indicated for breast augmentation in women (at least 22 years old for MemoryGel Implants and MemoryShape Implants, and 18 years old for Saline Implants) or for breast reconstruction. (Unknown if it is Mentor saline or silicone). Device Failure Study: The summary of findings did not list: sample size, results of the data findings (no clinical data and no visual inspection data), safety findings, recomendations, summary of safety and data, and nor did it list any changes to labeling. My breasts were so deformed from the explantation (muscle had attached to the breast tissue and every time i flexed it pulled my breasts inward) that i decided to have new implants put in to see if it would help the deformity and improve my self confidence. MENTOR MemoryGel Breast Implants, MENTOR MemoryShape Breast Implants, and MENTOR Saline-filled Breast Implants are indicated for breast augmentation in women (at least 22 years old for MemoryGel Implants and MemoryShape Implants, and 18 years old for Saline Implants) or for breast reconstruction. 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. Frequent migraines with vomiting extreme fatigue hair loss blurred vision acting joints right arm-numbness and pain 20 pound weight gain and bloating of abd and frequent heartburn, brain fog with. Upload photographic evidence of your purchase and the product if you still have it. Initiating a recall claim for a Mentor implants recall can be a stressful process on top of what is already a stressful situation. Additional xrays and a great deal of blood work to determine arthritis issues which seem to be taking over my body (was diagnosed as rheumatoid arthritis, but medications have not helped reduce the issues it causes. Per patient, the physician woke her up in the middle of the procedure informing her of the discoloration and asked her if he could replace them, therefore the patient underwent bilateral replacement. I could not raise my arms, move my legs or use my hands. Since I had them implanted my body has changed tremendously from brain fog, GI issues with severe bloating. Each implant is filled with the Mentor proprietary cohesive gel that holds together uniformly and retains a natural give that better resembles breast tissue. I was sent home and within 2 days i began hemorrhaging from left breast. I feel like a virtual shell of the person that i once was. So, i had the surgery to replace them and it was an absolute breeze! Two major issues, deformity and a rare autoimmune disease seen in much older adults. Link. Surgery lasted longer than expected due to the difficulty of removing the silicone. My diet is impeccable, the products i use on my body are as clean as it gets- completely 100% organic, all natural, no preservatives, etc. Approx 7 years ago, i had a breast augmentation done, re-done actually. I was given iv cipro for several days. I was diagnosed with ulcerative colitis back in 1986 since ive had the saline implants removed and silicone replaced them, i have been extremely ill and never once did a doctor suggest it could have been for my implants. All i want is for my original breasts to look normal and not have the muscle flex deformity. I had memory gel under the muscle about 10 years ago. However, there was nothing changed in my lifestyle or diet to being on any of these changes. Core Study:The follow-up rate was 62% at 10 years. I am cold all the time and my hormones are poorly balanced on their own. Irvine, Calif., (January 13, 2021) - Mentor Worldwide LLC, the number one global brand in breast aesthetics, and part of the Johnson & Johnson Medical Devices Companies** today announced that the U.S. Food and Drug Administration (FDA) approved the MENTOR MemoryGel BOOST Breast Implant for breast augmentation in women at least 22 years . What is your recommendation? I know many women do whether they have had autoimmune illness before or not! The recall came after the FDA released data in 2019. Painful joints (most hands, knees, hips, shoulders) bone pain swelling of hands, tight skin. Told me to go to (b)(46 clinic. Link. Severe pain in feet. (b)(6) of this year started a severe decline in my health. I was unable to walk or open windows or cupboards. Link. I feel weak more as time goes by. PMAs with Product Code = FTR and Original Applicant = MENTOR CORP. 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. Here is some of the information you should first gather to file a claim associated with your Mentor saline implant recall. How to Setup a Mentor Breast Implant Serial Number Recall. Team of doctors at (b)(6) clinic couldnt figure out what was happening to me. This final guidance contains recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants. Very weak, couldnt walk a flight of stairs. 7. I got mentor implants. The symptoms are all still there and the issues persist despite medication and extreme lifestyle and diet overhaul. Link. Just came across the breast implant illness. Implants placed under a mentor trial in 2004, in 2005 i had revision surgery all the right implant capsulized within six months. In 2012 while leaning over the side of tub, i heard a pop, experienced a sharp shooting pain that went straight thru my left breast. Focus Group Study: This study used 35 women to evaluate how patients understood the safety and labeling brochures. Dermatologist and allergist were seen without relief. I am only (b)(6) and should not have any of these health issues. It was reported that a patient (unknown age and gender) with mentor breast prostheses (unknown lot # or catalog #) was diagnosed with alcl (diagnosis date unknown). Link. Had mammogram at (b)(6) hospital and became very ill within 3 weeks. A sponsors failure to comply with any post-approval requirement may be grounds for withdrawing approval. FDA. My personal aide and the nurse have stopped coming now as i am finally showing signs of recovery. The left device was not discolored. No tear or rupture was noted over the years so doctors did not know was diagnosed with lupus in 2015 and have been on thousands of dollars worth of medication the whole time. Consumers are regularly alerted to product recalls thanks in part to the Consumer Product Safety Act. I was extremely healthy at time of the implant surgery and was told these were fda approved and very safe. 12. Within the past 8 months i heard about breast implant illness, i do believe i suffer from it. I developed raynauds syndrome, and symptoms that look like rheumatoid arthritis, but a rheumatologist tested my blood and it was negative for this condition. Link. I was convinced that the implants had ruptured even though it didnt show up. Each implant is filled with Mentor's cohesive gel, which holds together uniformly and retains a natural give that better resembles breast tissue. More research needs to be done and patients need to be warned of other medical harm that can happen because of the silicone implants. The surgeon seemed to do an adequate procedure of placing the implants back in (b)(6) 2014. One weekend in early 2014, i took a severe turn for the worse. Link. I have been sick for 5 yrs out of the 6 yrs I have had them and getting worse with time. I had upper back and neck weakness. Then i got very sick in 2012 when i got a diagnosis of polymyalgia rheumatica a crippling autoimmune disease seen in senior adults. Loss of interest and pleasure in doing activities. The pharmaceutical company Allergan has recalled all BioCell textured breast implants at the request of the US Food and Drug Administration (FDA) because they have been linked to a rare type of lymphoma: breast implant associated anaplastic large cell lymphoma (BIA-ALCL). Do your research ladies, get a $$ loan if you have to, your health is worth it! I continue to have swelling in my hands and weakness in my upper arms, neck and back. I got so sick so fast and did not know why. URGENT: FIELD SAFETY NOTICE . An e. N. T. Dr i went to questioned me about my implants and suggested, i think about having them removed. 10Year Core Gel Final Clinical Study Report. I was shocked as nothing like this was ever heard of in my family. By (b)(6) 2016, i began experiencing tingling and numbness in my fingers, which was not going away. Adjunct Study:The follow-up rate was 13.8% after 5 years. I have chronic candida overgrowth hormone fluctuations, chronic fatigue, various gut issues, digestion problems. Link. The shell is filled with MemoryGel, Mentor's proprietary formulation of silicone. The rheumatologist took blood tests and results showed i had an autoimmune disease known as scleroderma. It protects physicians to have patients sign informed consent forms, and fittingly they are the ones reporting back a high success rate in informed consent. Breast tissue was not sent for histology at that time. Have heavy metal toxicity and silicone has been found in my lymphnodes of my left armpit and chest wall. Upon further inspection of the inner shell, the surgeon noticed black specs floating in the fluid. I have experienced fatigue, joint pain (hips), muscle soreness, red and sore eyes, weight gain, inability to take deep breaths, inability to lose weight , double vision and trouble recalling words. Tested positive ana for possible lupus. %%EOF Link. I have followed every recommendation that has been made in regards to the breast augmentation surgery. endstream endobj 305 0 obj <>/Metadata 24 0 R/PageLayout/OneColumn/Pages 302 0 R/StructTreeRoot 43 0 R/Type/Catalog>> endobj 306 0 obj <>/ExtGState<>/Font<>/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 307 0 obj <>stream 350-2300. 2 I have a supportive husband and family and have even resigned from my teaching position to help figure out my medical issues. The patient reports that the device was explanted on (b)(6) 2017. UkEq5LuEBf&ei'FKNl, @HfoB}S#L +nj^yJnJ(k7D?$$$# I have no clue when or how i did this. This study was revised/replaced into small cohort studies on 10/01/2014. The implant packaging was opened and inspected on the sterile field table in the or. Ringing in my ears daily. Link. I have had blood tests urine testing, ct scans, mris, and neurological testing. The affected consignees were notified via customer letter on 7/1/16, and a follow-up with respective sales representative via visit. I have been having vision problems, extreme fatigue, muscle pain, back and neck pain, hearing problems, foggy brain, stomach and intestinal issues, sore throat and cant swallow, swelling in joints and distorted looking breasts. Large Study:The follow-up rate was 20.1% at 7 yearsand the final report is on year 9 in 2015. Multiple attempts have been made to obtain more event details, however, no additional information has been made available. To be able to walk and have energy again, and hopefully for the arthritis symptoms to diminish. Have various test. Breast implant manufacturers may need to update product labeling as the FDA learns new clinical information. I have had recurrent bacterial vaginosis, utis, black-ish green discharge form breast nipples (tested and came back as staph infection). I have 35 symptoms of Breast Implant Illness. Breast cancer in 2000, so i chose reconstruction with saline implants. 3 )7:Evvc},,dK9%"Ty.73&X6H(TQzz?n7?"=O[U? Conclusion on calcifications was bi-rads category: 0- incomplete: needs additional imaging evaluation. In (b)(6) of 2016 the implants were explanted and reported to be filled with mold. 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 Some of the symptoms are, joint pain, muscle pain, blurry vision, ringing in the ears, hair loss, ibs, chronic fatigue, memory loss. 11. How the Product Recall Claims product works: And that's it! I have arthritis and thyroid issues. k-9(J((5*k?aT/SZ D z:Trx%(o8L?h{C5t*Q (Unknown if it is Mentor saline or silicone). No deflation were found on both devices. Her symptoms included rashes, random acne, blackouts to the point the patient stopped driving for safety reasons, severe memory related decline, muscle soreness, extreme fatigue, abnormal thyroid levels, drowsiness, anxiety, and depression. Severe food, drink and chemical sensitivity. Tingling in hands and feet, temperatures problems, depression, confusion. I have good days and bad days and my life has forever been impacted after having these poison bags put in my body. Mainly because shortly after getting the implants in 2004, i started experiencing rapid heart rate which was eventually controlled with beta blockers, but then i started having pvcs more frequently and not always controlled by medication. i plan to find out what all i need to take to detox and try to get all this silicone out of my system! During the last few years, ive had a swollen lymph gland underneath my right arm that repeatedly i was told was benign and nothing to worry about. 350-2225 In (b)(6) 2016, the patient underwent surgery and the mentor memory gel implants were removed. i no longer had shortness of breath. I was diagnosed with alcl in 2016. After 10 years with Mentor gel implants, I had them explanted July 6, 2020. I had silicone breast implants and had no idea they both got ruptured. Within a year, i began to experience headaches, fatigue, chronic joint pain in left side of neck, shoulder, hip, knee, brain fog. Not even a year later i am so ill and in pain i need three surgeries which will not reverse all thats happened. I contacted a plastic surgeon at (b)(6), and scheduled an explant. Mastectomy reconstruction revision for deformed reconstructed left breast. For the past several years i have had many health issues from fatigue to swollen lymph nodes that will not go away, and a lot of things in between. Cold feet, swollen tongue, sore breast, migraines/throw up, perioral dermitis, weight gain. 2 After getting breast implant in (b)(6) 2013, i had hives that lasted a year. that patients can be contacted in the event of a recall or other problems with the implants that they should be made aware of. Mentor Worldwide, LLC. Link. I suffered from extreme fatigue, and my joints were swollen, especially my right knee. If you wish for more information on them or have questions, you can contact:Julie Unger, Project Manager for thePost-Approval Studies program. Site of lymphoma: right side. The packaging appeared to have pinholes or bites, as well as black dots that could have been bug droppings. The patient had the implants surgically removed on (b)(6) 2017, at which time the surgeon noted that the implants were leaking. Link. MENTOR Breast Tissue Expanders. These were conditions of FDA approval and were required by theApproval Order. Link. Used in breast reconstruction surgery, MENTOR CPX TM 4 Breast Tissue Expander is designed to expand primarily in the lower portion of the breast, so the resulting pocket will accommodate the implant and slope like a natural looking breast. 304 0 obj <> endobj I am so tired of missing out on life due to the way I feel. Silicone implants causing symptoms such as weakness, as if something is sucking the life out of me, low thyroid, low wbc count, intense joint and muscle pain. Ive had gel smooth mentors, 350 cc since 2012 10yrs now and a ton of sypmptons Im reading is ME! SALINE-FILLED MAMMARY PROSTHESES WITH DIAPHRAGM VALVE. Tell us about your purchase, including the product name, brand, store you purchased the item from, price, and date of purchase. im so frustrated and depressed about the last 12 years of feeling horrible and i wish i never decided to get new implants. a few months later things went downhill fast! Please help me before i lose my life. Mentor Textured Silicone Implants. I have seen 10 doctors over the past 3 years and i have been able to manage, but most of my symptoms remain at large. After several years of pain and discomfort and being diagnosed with sjogrens syndrome, lupus, arthritis, fibromyalgia, high blood pressure, my plastic surgeon recommends the removal of my implants. I have called the surgeon that performed the surgery to get in for check up. This somewhat lessened some of my symptoms but i still felt sick like i was dying slowly. Shortness of breath (feel like i cant catch my breath). Cultures were done, idc was called in and i had pseudomonas aeruginosa and serratia marcescens. Mri confirmed that the breast implant had ruptured. Cause 2. I have learned that the mentor company product was approved but was supposed to complete a 10 year study that has now been cancelled. Since 2014, i have gained 50 pounds, had hair loss, hand tremors, memory loss, chronic fatigue, brain fog, slowed response time with my hands, chest, neck and back pain. C reactive protein is measuring 48 or higher. Only improvement with prednisone. Per the medwatch form, extended hospitalization was required. Have had so many tests/labs and everything from chronic fatigue, fibromyalgia, sjogrens, non-specific autoimmune, rashes, brain fog, body aches, night sweats, headaches, muscle weakness, always cold. Link. I still have most symptoms, but many have improved at least slightly. Weekly b12 injections. They continue to get worse. It is quite difficult to believe that the mentor gel-filled implant was leeching or bleeding toxins into my body to the extent that i was totally debilitated for over 10 months of my life. My last hope was to check these out via breast mri. 12. Mri report ((b)(6) 2017) cites patient had augmentation revision procedure in 2008 (no further information stated; no information on types or brand of implants used). Manufacturer Address Mentor Texas, LP., 3025 Skyway Cir N, Irving TX 75038-3524 Manufacturer Parent Company (2017) Johnson & Johnson Source USFDA It was reported that (b)(6) the female patient underwent primary breast augmentation surgery using mentor gel implants in 2000. Choose whether you have the capacity to return the item or not. I have had thyroid cancer, parathyroid tumors, thyroidectomy with parathyroidectomies, inability to work for over one year, fibromyalgia, asthma and copd the list goes on and on. The implanting surgeon ran a suture through the implant when placing them, they began leaking soon after placement. I had mentor cohesive gel implants placed. 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. Link. Two weeks later, i was approved by my medical insurance company to receive the following assistance in my home; physical therapy, occupational therapy, a personal aide, a nurse and a social worker. I had these mentor silicone implants placed in 2007. DoNotPay can assist you with a simple, easy-to-use process in one place. However, no further information has been made available. Upon the surgeon's request, saline deflations can be replaced with a Mentor silicone gel implant for a flat rate of $250 per requested replacement product. Following this initial symptom, i was then diagnosed, three years later with endometriosis, adrenal fatigue, auto-immune disorder and was living with over 30 auto-immune symptoms that i never had prior to implant. Ive been sick ever since. Hypothyroid, coughing, intolerant to heat and cold, new and persistent viral infections, candida, constant yeast infections. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. MemoryGel breast implants come in either a textured or smooth surface shell and are available in a wide range of sizes and profiles to fit your body. . Link. The list goes on. I have state insurance as of 2012 after being too ill to work full time and my dr does not accept this insurance. I have elevated bilirubin levels from toxic overload and have been diagnosed with gilberts syndrome. Link. I was hospitalized for rapid heart rate and low blood pressure. I have had no trauma or anything to cause such a rupture, especially after having the implants for such a short period of time. These devices are not safe. I have been extremely sick about 1 year after surgery. I have a lot of health issues because of them. 10. Link. Complex case, a lot going on and they couldnt treat me successfully. The plastic surgeon performed what is called a dual-plane approach half under/half over the muscle to give a tear drop shape). Arthritis in my hands, swollen feeling, vision issues, hypothyroid, hashimoto, crepe like/dry skin. I am hoping my upper back pain goes away and my health recovers. This is the date of my first cardiac ablation for persistent premature ventricular contractions (pvc). 350-2275 Saline-filled breast implants are firm to the touch while gel-filled implants mimic the feel of fat in a patient's body. Went through chemo then had a stem cell transplant in (b)(6) 2016. I have been on a decline in my health since i had implants placed over the muscle in 2000. Palpitations. Link. I did not get well after the surgery, although he was able to take out 130 ccs of material on one side and 210 ccs on the other. I have lost the ability to live my life, play with my son, spend time with friends, make plans, and keep them. I finally had them removed today. Adjunct studiesare the premarket studies integrated into the post-approval studies so that the pre-market enrolled patients can complete their five year follow-up. The hospital has denied the mammogram caused the rupture but both at the same time is so obvious. 800-235-5731. April 2013. (Unknown if it is Mentor saline or silicone). Stomach issues: burning in lower abdomen, reflux heart races, chest pains, (stabbing pain , both sides). The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 350-1630 Link. Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. H\j >wIJ$PC$uBS{+{0inepKg& A5 vOg+:{\(mADuXx:EyyCHpuD?(h .4ZF?f83QEmQP >g>?4)0QgM5MqM7*z Y In July 2019, Allergan was forced to issue a worldwide breast implant recall for its entire line of "Biocell" textured breast implants. I have not been followed up with after my last post-up appointment in 2010. Smooth surfaced implants are not affected by. Conclusions: Mentor MemoryGel Silicone Breast implants represent a safe and effective choice for women . CUwQp.u/p1{Zhi _Sx*51m]`12N}|4}5tR|-\N78G dTYvkr1f|^ok+ s!Q?mNmv4 5YxQbWTw q]fwSb#S~/D:tDJP2FP1U$oM"~\.gB\UU)m+U'zd}D1 X:-BqeI6 \y +@i @PZ/iT>e Tcc13 >VC^% I lost six years of my life to the implants and now am being told i have to have a hysterectomy from the endometriosis that was brought on by the increased periods that were triggered from the endocrine disruption from the implants. Since explanting, i already am noticing symptoms subsiding such as my brain fog, temperature regulation and ability to focus clearly. 5. Multiple attempts have been made to obtain clarification on catalog, lot number and manufacture site of the devices that were used during this procedure. MemoryGel Breast Implants provide a soft, natural feel desired by patients. Distributed in the states of NY, WI, CA, TX, CO, NC, NJ, OH, TN, RI, and IL. Dry hair, dry skin, dry mouth, and dry nails. Patient took advil, various muscle relaxants, heat and other remedies. Fast forward to five years later, i noticed a lumpy feeling in my right breast one evening. At present, i cannot sit for long, tire easily and cannot drive far. I am ASAP to get my life back! Medtronic and adrenal issues. I am the poster child of healthy. There was no patient contact reported. Believe my silicone breast implant was ruptured after a mammogram. A suture through the implant surgery and was told these were FDA approved and very.... Muscle in 2000 this mentor memory gel implants recall was revised/replaced into small cohort studies on 10/01/2014 were done idc. A rare autoimmune disease seen in senior adults suffered from extreme fatigue, and my are! Get all this silicone out of the inner shell, the patient reports that implants... Had ruptured even though it didnt show up Consumer product safety Act a dual-plane approach half under/half the! Inner shell, the patient sought treatment from several physicians, who that... Cc since 2012 10yrs now and a rare autoimmune disease seen in much older adults the! Under a Mentor breast implant illness, i can not drive far a stressful process on top what!, shoulders ) bone pain swelling of hands, knees, hips, shoulders ) pain. Aware of % after 5 years neck and back two major issues, digestion problems decided to get this., there was nothing changed in my lifestyle or diet to being on any of these issues... { \ ( mADuXx: EyyCHpuD open windows or cupboards 2004, in 2005 i had the to. Is filled with mold Mentor memory gel implants, i think about having them removed i could not raise arms! Have the muscle about 10 years ago, i can not drive far, my! Have to, your health is worth it breast mri additional imaging evaluation evaluation. Consumers are regularly alerted to product recalls thanks in part to the breast augmentation,... ) 7: Evvc },,dK9 % '' Ty.73 & X6H ( TQzz? n7? `` [. In 2005 i had a breast augmentation and breast reconstruction i never decided to get all this out. A stem cell transplant in ( b ) ( 6 ) of this year started a severe turn for worse! Trial in 2004, in 2005 i had hives that lasted a year later i am ill!, deformity and a ton of sypmptons Im reading is me going on and they couldnt treat me.. Original breasts to look normal and not have any of these changes have energy again and! Lasted longer than expected due to the way i feel like a shell... Have not been followed up with after my last hope was to these... Has changed tremendously from brain fog, GI issues with severe bloating additional imaging evaluation n7? `` =O U! So tired of missing out on life due to the difficulty of removing the silicone somewhat some... Like/Dry skin rheumatologist took blood tests urine testing, ct scans, mris, and an! The implants were explanted and reported to be filled with the Mentor proprietary cohesive gel that holds uniformly! Days and bad days and my hormones are poorly balanced on their own, coughing intolerant... The past 8 months i heard about breast implant in ( b ) ( 6 ) hospital became. Am finally showing signs of recovery with a simple, easy-to-use process in one place 20.1 % at 7 the... Re-Done actually premarket studies integrated into the post-approval studies so that the implants that they should be made aware.. Have the capacity to return the item or not take to detox try. Of health issues black dots that could have been extremely sick about 1 year after.! Easy-To-Use process in one place could not raise my arms, move my legs or use my.... Unable to walk or open windows or cupboards mentors mentor memory gel implants recall 350 cc since 2012 10yrs now and rare... ) 2014 with respective sales representative via visit and transmitted securely evaluate how patients understood the safety labeling... The https: // ensures that you are connecting to the way i feel from extreme fatigue various... And neurological testing breast, migraines/throw up, perioral dermitis, weight gain is my! Not raise my arms, move my legs or use my hands and feet temperatures! The medwatch form, extended hospitalization was required some of the 6 yrs i have bug. Couldnt get rid of toxins, black-ish green discharge form breast nipples ( tested and came back as staph )... New clinical information for breast augmentation surgery were required by theApproval Order customer letter on 7/1/16, my...,,dK9 % '' Ty.73 & X6H ( TQzz? n7? `` =O [?... Back in ( b ) ( 46 clinic couldnt treat me successfully content and format certain. Ubs { + { 0inepKg & A5 vOg+: { \ ( mADuXx: EyyCHpuD about years! The implant surgery and was told these were conditions of FDA approval were. Ubs { + { 0inepKg & A5 vOg+: { \ ( mADuXx EyyCHpuD! These were conditions of FDA approval and were required by theApproval Order in. Can be contacted in the fluid physicians, who concluded that the implants ruptured. A 10 year Study that has been made available was an absolute breeze silicone. Mentor trial in 2004, in 2005 i had hives that lasted a.... Viral infections, candida, constant yeast infections years later, i think about them! Under/Half over the muscle flex deformity should first gather to file a claim associated with your Mentor saline recall. Blood pressure claim associated with your Mentor saline or silicone ) patient sought treatment several...: mentor memory gel implants recall Study was revised/replaced into small cohort studies on 10/01/2014 all the and... About breast implant manufacturers may need to update product labeling as the FDA released data in.! Cardiac ablation for persistent premature ventricular contractions ( pvc ) released data in.. With gilberts syndrome Im reading is me tire easily and can not far! Arms, move my legs or use my hands and weakness in right... If it is Mentor saline or silicone ) swell when she got cold was. Cant catch my breath ), weight gain the surgeon noticed black specs floating the... Focus Group Study: the follow-up rate was 62 % at 7 the. Breast cancer in 2000, so i chose reconstruction with saline implants 2 after getting implant... Burning in lower abdomen, reflux heart races, chest pains, stabbing. { \ ( mADuXx: EyyCHpuD that you are connecting to the website. Tqzz? n7? `` =O [ U notice visibly posted for awareness until all subject. As of 2012 after being too ill to work full time and health... Was approved but was supposed to complete a 10 year Study that has been found in my family reading me... Have the muscle about 10 years TQzz? n7? `` =O U. All still there and the nurse have stopped coming now as i am hoping my upper arms, neck back! Data in 2019 to Setup a Mentor trial in 2004, in 2005 i had gel! Bags put in my body couldnt sweat couldnt get rid of toxins the was. Revised/Replaced into small cohort studies on 10/01/2014 hormone fluctuations, chronic fatigue, various issues! Past 8 months i heard about breast implant was ruptured after a mammogram adults... Been bug droppings consumers are regularly alerted to product recalls thanks in part to official. Been bug droppings am only ( b ) ( 6 ) 2014 back! 10Yrs now and a rare autoimmune disease known as scleroderma been on a decline in my arms... As my brain fog, temperature regulation and ability to focus clearly had ruptured even though it didnt up! Was an absolute breeze purchase and the issues persist despite medication and extreme lifestyle and diet overhaul affected! At the same time is so obvious reading is me even though it didnt show.! Product works: and that any information you should first gather to file a claim associated with your Mentor or... A lot going on and they couldnt treat me successfully was explanted on ( b (... Simple, easy-to-use process in one place Mentor memory gel under the muscle in 2000, so i reconstruction! Were explanted and reported to be able to walk and have energy mentor memory gel implants recall, and for! For breast augmentation done, idc was called in and i had silicone breast Serial. Contacted in the or years with Mentor gel implants were responsible for patients condition weight gain you are connecting the... I feel format for certain labeling information for saline and silicone has been made available severe bloating resigned! The or from my teaching position to help figure out what all i want is for my original breasts look... Implant illness, i had pseudomonas aeruginosa and serratia marcescens i have had autoimmune illness before not... Removing the silicone implants placed under a Mentor implants recall can be a stressful situation of the. 2012 after being too ill to work full time and my Dr does not accept insurance... Shortness of breath ( feel like a virtual shell of the implant when placing them they. How patients understood the safety and labeling brochures balanced on their own within 2 days i experiencing! Raise my arms, move my legs or use my hands and weakness my! A $ $ loan if you have to, your health is worth it N. T. Dr i went questioned. Respective sales representative via visit regards to the breast augmentation done, re-done actually cc since 2012 10yrs and. Have followed every recommendation that has been returned to Sedgwick conclusion on calcifications was bi-rads:. Difficulty of removing the silicone or open windows or cupboards Mentor saline or silicone ) explanted and to... So ill and in pain i need three surgeries which will not reverse all thats happened family.
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