mentor memory gel implants recall
As time continues to pass, more symptoms seem to be showing up. Urine test show protein, my legs, ankles and feet are swelling, still experiencing pain in left wound, hard round know has formed in the center, some swelling remains, as does pain. Link. 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. 12. Knee/joint pain. I got so sick so fast and did not know why. Please take these off the market. 800-235-5731. Lowered immune system, and i get sick (strep throat, colds) and i never used to, slow clearing of colds. Link. Patient felt symptom-free almost immediately after removing implants. Then depression and daily anxiety became an issue. Last night I already started the ball rolling to see an EN BLOC explant removal expert surgeon closest to me and by the grace and mercy of God i found one! Had breast implants put in and have had failing health since. They were hard as a rock from the beginning and extremely uncomfortable throughout and especially toward the end. Large Study:The follow-up rate was 20.1% at 7 yearsand the final report is on year 9 in 2015. Ringing in my ears daily. Rushed to surgery for third time. My personal aide and the nurse have stopped coming now as i am finally showing signs of recovery. Customer Service. Link. Another said i was an interesting case as tests for memory mostly showed fairly bad short term memory. At least make every day doctors like rheumatologists aware that this is happening, and what can happen if they dont treat it right away. Cant handle the sun anymore, can no longer jog/run. The following section provides links to the approved labeling and the progress of expected labeling supplements. My upper body muscles ache, and i continue to have difficulty sleeping. it looks like thats what i am coughing up sometimes like i said its extremely sticky. 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. Mentor reports this event with an abundance of caution. (Unknown if it is Mentor saline or silicone). The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. I have been ill since having silicone implants fibromyalgia, sleep disorder, pain in neck, shoulders, hips, legs, feet, and back. I started having serious difficulty breathing at all times, and especially when laying down at night. I have been extremely sick about 1 year after surgery. I had reconstruction due to breast cancer with mentor memory gel silicone implants 300cc. However, there was nothing changed in my lifestyle or diet to being on any of these changes. I have gone through all my savings trying to get better! Hair was falling out, constantly getting sick with sinus issues cold, cough, infections, strep, sore throat, brain fog, tired, low libido. Within a year of receiving mentor silicone high profile breast implants my health had declined tremendously. Link. Tingling hands and feet, cold hands and feet, tempt, intolerance, light sensitivity and noise sensitivity. It started with pain, fatigue, numbness, concentration, and memory loss, which has now triggered an autoimmune response and high levels of toxicity in my body. The new labeling approved on October 27, 2021 follows from the labeling recommendations described in the FDAs September 2020 guidance. Note: If you need help accessing information in different file formats, see Link. Since then i had a lot of health issues, most of them have been of autoimmune reactions involving: vascular system, neurological (brain fog, numbness in limbs), asthma, heart palpitations, extreme fatigue, hormonal issues, sensitivity to chemicals, allergies. The patient felt discomfort which she had not previously experienced. At present, i cannot sit for long, tire easily and cannot drive far. 350-3330 I still have most symptoms, but many have improved at least slightly. Consumers are regularly alerted to product recalls thanks in part to the Consumer Product Safety Act. endstream endobj 308 0 obj <>stream First, the FDA issued orders restricting the sale and distribution of breast implants to help ensure that patients considering breast implants are provided with adequate risk information so that they can make fully informed decisions. 350-3460. I decided to try silicone this time because they are supposed to be softer and i figured they would not press on my chest and make it hard to breathe. 350-2300. Link. The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates. Surgical assistant informed me after surgery that i had a ruptured implant, that it was a sticky, gooey mess, and that the doctor has never seen anything like it before. I have a lot of health issues because of them. Bruise easily. Updated silicone gel-filled breast implant rupture screening recommendations. Menstrual period only twice or so a year (started in 2008 after implants). 350-1645 the Large Study) have been restructured into multiple smaller studies (Case Control Studies, MemoryGel and Shape Combined Study, Re-Op study). Mastectomy reconstruction revision for deformed reconstructed left breast. FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements (3/19/19). Failure to file a claim due to frustration with the recall process, a lack of time, or a lack of understanding of the necessary steps to make a claim will no longer be an issue with the recall assistance of DoNotPay. DoNotPay will send your implant recall request to the manufacturing company on your behalf, asking for a refund or replacement. Choose whether you have the capacity to return the item or not. Cultures were done, idc was called in and i had pseudomonas aeruginosa and serratia marcescens. I had a 3-d mammogram and everything looked fine. Started feeling ill within a year, by year 3 i was so sick my labs pointed to lupus or sjogrens. 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^% She had both breast implants removed on (b)(6) 2016 and gained self-esteem ever since. 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 Rheumatologist said i am at high risk for lymphoma. In doing my research, i trusted the fdas recommendation that these were very safe implants. These were conditions of FDA approval and were required by theApproval Order. WRONG!!!! Contact the relevant medical authorities who conducted the surgery and request an updated Mentor breast implant recall information. Mentor Worldwide Historical Implant Data 1985 May 2018. Per the customer, the plastic wrapping the implant boxes was also damaged. 350-2200. I have elevated bilirubin levels from toxic overload and have been diagnosed with gilberts syndrome. Weight gain, heavy and abnormal menstrual cycles, heart palpitations, chronic diarrhea, muscle cramping/frequent charlie horses, frequent swollen and sore lymph nodes usually under arms sometimes neck, sensitive eyes, enlarged thyroid, allergies for the first time in my life, pain where the ribs meet the sternum. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. So, i had the surgery to replace them and it was an absolute breeze! The sale and distribution of Mentor Breast Implant Devices are restricted to users and/or user facilities that provide information to patients about the risks and benefits of the device prior to its use in the form and . Link. The patient had the implants surgically removed on (b)(6) 2017, at which time the surgeon noted that the implants were leaking. The packaging appeared to have pinholes or bites, as well as black dots that could have been bug droppings. I am having a had reaction to my mentor silicone memory gel implants that were placed under the muscle three years ago. This began to get out of hand this (b)(6) and i began to research to figure out what was going on. Please help me before i lose my life. More research needs to be done and patients need to be warned of other medical harm that can happen because of the silicone implants. Mentor Silicone Gel-Filled Breast Implants are devices with shells constructed from silicone elastomer. Link. I had developed severe food allergies and a few other symptoms about a year prior to the rupture, but thought nothing of it. Link. Six months after implants got (b)(6), along with unexplained weight loss, reoccurring shingles, and fatigue. 1* Choose from a wide range of sizes and profiles including Moderate Classic, Moderate Plus, High, and Ultra High. Had many blood test and i have all of the results. This final guidance contains recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants. The plastic surgeon at (b)(6), removed the implant material by opening up what was left of the capsules rather than using the en bloc method, which is now standard. Link. I was implanted with mentor memory gel silicone breast implants. Tell us about your purchase, including the product name, brand, store you purchased the item from, price, and date of purchase. Auto immune disease, hands were swollen, red, and itchy. Informed Decision Study: Overall, this study seemed self-serving to the physicians who are ironically the ones conducting the study on their patients. I felt like i was dying. It was reported via mw 5065152 that a female patient underwent a bilateral breast augmentation surgery in (b)(6) of 2013. No further information is known regarding the patients medical history, status, hospitalizations, medical or surgical interventions that were performed. Memory problems, disturbing enough to affect me emotionally as well. Since the removal of the implants, i have had 2 addl reconstruction surgeries including a latissimus flap. I am disgusted how they use the fda as a scapegoat to dismiss womens health issues with breast implants, and i am also disgusted how the fda blindly approved something with over 25 toxic chemicals to be placed inside a womens body. Over time since implants. 'D))2eYhkE1yj{Y0\. Skin rashes only getting worse and slight fibromyalgia diagnosed by dr. (b)(6). Patient was diagnosed with left implant rupture around (b)(6) 2015 and got implant removed on (b)(6) 2015. 350-1635 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. 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. I have mentor breast implants that were placed in (b)(6)2007. dizziness (light headedness). When i told the rheumatologist on (b)(6), that i had an implant and that i had made an appointment to see my plastic surgeon the very next day she said, you are right to mention this to me. (Unknown if it is Mentor saline or silicone). 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. DoNotPay is an ever-expanding AI program to assist with a variety of online records or license requests, applications, disputes, claims, recalls, and more. Updated labeling to communicate long-term study results may not be available for all implants in this table. /f&b2jy|/ZS [=s A lower risk of complication is rupture. Have heavy metal toxicity and silicone has been found in my lymphnodes of my left armpit and chest wall. SQ*ONlG7[Gqt9`)/kKJ`%KP\gmht(1IsNeX|J-J|beLYh7uq&%#y6i/UsBA{GxZB5-8nWW!A`y]4M6AbQb&'g*-i!czb@68CsbD6UHpVq hx/Mebx- s. Through our Product Recalls, all you have to do is tell us about the product you purchased and provide receipts/other evidence, and we'll contact the company on your behalf. From 2014-2015, some studies (e.g. Within 3 months, my health took a sharp decline with life threatening arrhythmia issues which required cardiac ablation and meds. Shortly after, i began to experience a myriad of unexplained symptoms including anxiety, thyroid levels off, debilitating fatigue, dry eyes, blurred vision, brain fog, dizziness, etc. This study was revised/replaced into small cohort studies on 10/01/2014. 350-1610 No reports of rupture or other product issues. The implants are scheduled to be removed on (b)(6). SALINE-FILLED MAMMARY PROSTHESES WITH DIAPHRAGM VALVE. Link. Multiple symptoms continue. I started seeking help starting with my gyn doctor who diagnosed hypothyroid at my yearly visit. Here is some of the information you should first gather to file a claim associated with your Mentor saline implant recall. In fact, since implantation i do not have a taste of alcohol and have become sick whenever i have tried to drink even in moderation. 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. The health consequences of a ruptured silicone gel breast implant have not been fully established. I explanted the implants on (b)(6) 2017 and shortly after, developed a hematoma (in the area the silicone had to be scraped away from around my collar bone) which burst, leading to a second surgery. The fatigue is devastating. Each implant is filled with Mentor's cohesive gel, which holds together uniformly and retains a natural give that better resembles breast tissue. The implants were silicone made by mentor 600cc. No improvement with nsaids (multiple tried). I have heart issues, fatigue, high metal to city that can lead to significant cardiac issues. Stomach issues: burning in lower abdomen, reflux heart races, chest pains, (stabbing pain , both sides). I eventually had to remove the left fallopian tube and both ovaries due to the severe pain. The FDA issued final guidance, Breast Implants - Certain Labeling Recommendations to Improve Patient Communication in September 2020. hb```l@(0>.JO;%.mP'cGGE[GCKGGG>aS4FeX#aD{9L'0baZ\C@Ib @w?Vf . I was sent home and within 2 days i began hemorrhaging from left breast. They were smooth, round, and saline, 270 on one side and 300 on the other. Ive been to the doctor many times complaining about the lymph gland being swollen and getting dismissed repeatedly, i could really use to use some advice or support. I have mentor breast implants for reconstruction from cancer 2015. During this procedure, the surgeon noted that the right breast was discolored (brown). 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