This past year has been the worst so far and i just explanted without replacing the implants because i am 100% certain they have been poisoning me and i am disgusted how the medical industry does not take these type of complaints seriously. I had a breast augmentation on (b)(6) 2015. Link. It was reported that one female was implanted with mentor silicone breast implants in 2006. (Unknown if it is Mentor saline or silicone). 1 MENTOR Breast Implants are backed I noticed it has a Ribble in it, and it has a bubble, the bubble caves in when touched. I suffered from chills, hallucinations, elevated blood pressure, fatigue and diarrhea. Symptoms: fatigue, endocrine issues, depression, panic attacks, insomnia, joint pain and cognitive dysfunction. 350-2350 my first ones were removed via the area incision and now i have an incision in the inframammary location. They ranged from fairly benign to increasingly more serious and problematic. CL)),3dais8#(@&w[M+zK$UCS6xf ;dsfV_Z{7ayS5& uRSbhdwp[YIf!q$QajFj'Ifn{%B[O->jt/ *k`=+~(l:71s Within 3 months, my health took a sharp decline with life threatening arrhythmia issues which required cardiac ablation and meds. I feel my breasts are ruined forever now. Implants placed under a mentor trial in 2004, in 2005 i had revision surgery all the right implant capsulized within six months. Manufacturer Reason. (Unknown if it is Mentor saline or silicone). Link. 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. Mentor reports this event with an abundance of caution. I went from saline smooth implants to textured cohesive gel implants. In doing my research, i trusted the fdas recommendation that these were very safe implants. Link. I was in a car accident in 2014. Immediately and every day since my surgery 3 weeks ago, ive had all of the same symptoms reappeared but even worse. My last hope was to check these out via breast mri. It was reported that a (b)(6) female patient with history of breast prosthesis implantations was diagnosed with left breast cancer. I am hoping i will get better after explanting. im so frustrated and depressed about the last 12 years of feeling horrible and i wish i never decided to get new implants. Don't let time and effort get in the way of taking advantage of getting what you need or are owed. I was unable to leave my house unaided from (b)(6) due to this illness. Mentor made a decision to file a fda medwatch report based on the above information; however, currently, there is no solid evidence in the literature to suggest that breast implant rupture alter the risk of breast malignancies. Important information: i have continued to get sicker and sicker and sicker without answers with this yuck that im dealing with. Irvine, Calif., (January 13, 2021) - Mentor Worldwide LLC, the number one global brand in breast aesthetics, and part of . Link. Here are my symptoms: hormones are imbalanced (out of wack), hypothyroid. I would say to anyone thinking about breast implants DONT!!! Date of explant is scheduled for (b)(6) 2017. Manufacturer site is unknown. I began using a cane, then a walker, and eventually had to be pushed in a wheelchair. Contact the manufacturer if you require additional information. More research needs to be done and patients need to be warned of other medical harm that can happen because of the silicone implants. Extreme swelling throughout my body had to use a lymphatic drainage machine 2xs per day for 75 minutes. Ongoing unexplained upper respiratory infections (went to sinus specialist and despite numerous tests she could not find cause), body rash, large itchy painful welts on my breasts, heart palpitations, anxiety and depression, joint pain, ringing in my ears, etc. I also have become intolerant to smells and chemicals. Most of the missing silicone was never accounted for, though. Another said i was an interesting case as tests for memory mostly showed fairly bad short term memory. A bilateral breast mri was done on (b)(6) 2017 due to recent diagnosis of left breast cancer (exact date of diagnosis is unknown) the mri was done to assess extent of disease and for possible contralateral disease. 11. She was scheduled to remove implants the following month. Multiple attempts have been made to obtain clarification on catalog, lot number and manufacture site of the devices that were used during this procedure. Unknown if it is Mentor saline or silicone: Mastitis, swelling, nodules and varius other illness. I feel like a virtual shell of the person that i once was. Upload photographic evidence of your purchase and the product if you still have it. 2 Damaged/faulty implants have ruined my health and many aspects of my life. Vitamin deficiency and i take weekly high dosages of vitamin d (50,000) and daily vit d (8,000) and im barely in the normal range. Rheumatoid arthritis sjogrens barretts esophagus with hiatal hernia achalasia, hypertensive les graves disease, severe brain god, severe back pain and behind my left breast, and the worst one of all is this yuck that is trapped in my throat that many women from the breast implant illness site seem to have but mine is extreme i cough up lots of mucus and its debilitating. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. After revision surgery, the patient experienced delay of wound healing and had two scar revision operations. Tell us about your purchase, including the product name, brand, store you purchased the item from, price, and date of purchase. They were very ripply as well. I have chronic candida overgrowth hormone fluctuations, chronic fatigue, various gut issues, digestion problems. Over the past 3 years i have slowly begun to improve. waiting for scheduled explant and lymphadenotomy when i will be hospitalized. Extreme chronic fatigue, atypical connective tissue disease, breathing problems laying down. So i am reporting my situation. I am the poster child of healthy. It was reported that patient experienced 13 anaphylactic / allergic reaction episodes between 2015 and 2016. PMAs with Product Code = FTR and Original Applicant = MENTOR CORP. Apparently mentor did not get the message about a ban on implants. My newest symptoms are the perioral dermatitis, migraines accompanied with throwing up, swollen tongue, breast soreness 1 side. I have good days and bad days and my life has forever been impacted after having these poison bags put in my body. My first symptoms in early 2000 with migraines. 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 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. I would not recommend implants to anyone. However, no further information has been made available. Tingling hands and feet, cold hands and feet, tempt, intolerance, light sensitivity and noise sensitivity. As of(b)(6) i no longer was able to work. I would give anything to have my life back. How to Setup a Mentor Breast Implant Serial Number Recall. Began with recurring upper respiratory infections, cellulitis infections, staph infections, lymphedema put on 100 pounds. I began suffering with a poor immune system, memory loss, brain fog, fatigue, insomnia, neuropathy, high blood pressure, migraines, eye sight and hearing and had to have tubes put into my ears and could not get out of bed most days. I know many women do whether they have had autoimmune illness before or not! 350-2225. There is no specific information regarding any diagnoses or symptoms. Stomach issues: burning in lower abdomen, reflux heart races, chest pains, (stabbing pain , both sides). Manufacturer requested implant and packaging directly from or team to investigate. She was diagnosed with rheumatoid arthritis one year later. Link. Right implant was found with thick fibrous capsule as well as intracapsular leak upon removal. Had breast augmentation in (b)(6) 2013. 350-3330 Sometimes cant even have a bra touch it. The patient also reported breast pain which appeared in 2016 along with lump in her breast. 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. Patient decision checklist, which must be reviewed with the prospective patient by the health care provider to help ensure the patient understands the risks, benefits and other information about the breast implant device. (D4T(']RNk7J 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. Dense breast tissue was confirmed by ultrasound. Manufacturer Address Mentor Texas, LP., 3025 Skyway Cir N, Irving TX 75038-3524 Manufacturer Parent Company (2017) Johnson & Johnson Source USFDA Worsened over a period of 5-7 years post implant. Link. One of the first signs that something was wrong was in early (b)(6) 2009. It is related to my breast implants in my opinion. Besides developing multiple food sensitivities, i have also developed an extreme sensitivity to mold and chemical exposure. This study wasto be conducted in Denmark, Germany, and the UK. FDA Recall. Medtronic and adrenal issues. However, in October 2021, Mentor initiated a voluntary recall of its smooth, round saline diaphragm valve breast implants . 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. Recent study shows patients and surgeons both preferred the MENTOR MemoryGel BOOST Breast Implant as feeling more like a natural breast versus another leading brand. Its not worth it. 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. 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. Once left breast was opened, implant was ruptured and silicone had settled into the fascia going completely underneath my arm pit and almost to my back. I started having sensitivity to foods which i never had before and the foods cause pvcs. Then depression and daily anxiety became an issue. It is also possible that you will not recoup the associated costs until after you have paid for the procedures and check-ups in advance. Now i am homeless. I had mentor cohesive gel implants placed. Immediately, my breathing was cured! Updated labeling to communicate long-term study results may not be available for all implants in this table. Six months after that surgery the left capsulized; however, surgery was not safe at the time. I could no longer get out of bed and had to have assistance bathing and dressing. a few months later things went downhill fast! I have mentor cohesive gel breast implants and experienced symptoms almost immediately. I had informed the technician that i had them. Link. Link. 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. Reoccurring infection like uti, bv that are persistent and often do not go away with one round of antibiotics, and bladder pain. 350-2325 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 memory loss and difficulty focusing anxiety and flat affect cold intolerance esp hands and feet. I have 35 symptoms of Breast Implant Illness. I lost 20lbs of muscle during this above-noted period, as my arm, leg and rear muscles atrophied, resulting in me being totally debilitated. Not even a year later i am so ill and in pain i need three surgeries which will not reverse all thats happened. Implant provides the natural feel patients desire with increased form stability to shape the breast. Something was wrong was in early ( b ) ( 6 ) 2013 have become to! 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