I have not been followed up with after my last post-up appointment in 2010. Link. I experienced horrific pain, consulted with pcp who ordered x-rays that showed no rupture. 7. This felt like something physical. As soon as 4 months after implantation i had an emergent visit to the er for vertigo persistent vomiting and dizziness. The hospital has denied the mammogram caused the rupture but both at the same time is so obvious. I do not smoke cigarettes, and rarely ever drink any alcohol. (Unknown if it is Mentor saline or silicone). Approx 7 years ago, i had a breast augmentation done, re-done actually. Conclusion on calcifications was bi-rads category: 0- incomplete: needs additional imaging evaluation. The new ones that suppose to be fda approved and safe ones. SQ*ONlG7[Gqt9`)/kKJ`%KP\gmht(1IsNeX|J-J|beLYh7uq&%#y6i/UsBA{GxZB5-8nWW!A`y]4M6AbQb&'g*-i!czb@68CsbD6UHpVq hx/Mebx- s. Have heavy metal toxicity and silicone has been found in my lymphnodes of my left armpit and chest wall. 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. Mentor strongly recommends that all patients receiving silicone gel-filled . Link. Tingling and numbness in face, hands, and feet. This generally occurs at the end of the ten-year post approval follow-up period for patients that received the implant during investigational studies and when new post-approval studies are completed. I was systemic. I was fine for the first two years. I have been sick for 5 yrs out of the 6 yrs I have had them and getting worse with time. Extreme hair loss that has created balding (alopecia) on my scalp. FDA Documents: Approval Date: November 17th, 2006 Recalls On October 27, 2021, the FDA took several new actions to strengthen breast implant risk communication and help those who are considering breast implants make informed decisions. 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 I have good days and bad days and my life has forever been impacted after having these poison bags put in my body. I just explained and am getting my health back. Breast pain near site of implants was dismissed and then appeased by suggestion to take both vitamin e and evening primrose oils (neither helped reduce pain/discomfort). My husband began to research that possible relationship. It is related to my breast implants in my opinion. I began using a cane, then a walker, and eventually had to be pushed in a wheelchair. Two major issues, deformity and a rare autoimmune disease seen in much older adults. I experience brain fog, trouble recalling words and im only(b)(6). Here are my symptoms: hormones are imbalanced (out of wack), hypothyroid. waiting for scheduled explant and lymphadenotomy when i will be hospitalized. The mammogram film showed the bursting of the implant. I suffered from chills, hallucinations, elevated blood pressure, fatigue and diarrhea. The new labeling approved on October 27, 2021 follows from the labeling recommendations described in the FDAs September 2020 guidance. 1 MENTOR Breast Implants are backed Extreme vitamin d deficiency. k-9(J((5*k?aT/SZ D z:Trx%(o8L?h{C5t*Q 13. I was a 34 B previously. 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. Skin issues were addressed with various creams/meds, none which resulted in improvement. 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. Over time since implants. 350-2250 350-2250. i am certain my breast implants are causing all of my health issues. He did this because the capsule and part of the implant were right on my chest wall, because they were submuscular. I had silicone implants put in (b)(6) 2014 and by (b)(6) 2015, i was getting sick. Abnormal blood test results since 2012. Link. 2 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. I got so sick so fast and did not know why. Spent a lot of money only to learn my implants made me sick i was diagnosed with fibromyalgia and hashimotos along with just guesses of what could be wrong. 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 . I am the poster child of healthy. I dont even know how to put it in words. I felt like i was dying. Dryness of mouth, hair, skin, and scalp sores, choking at night afraid, i wouldnt wake up. Dry hair, dry skin, dry mouth, and dry nails. HVmo6_qHDE(NqD0dJ!R[IY[>L(;uzgYf7Y>l2iLY2$H! 350-2200. I have chronic candida overgrowth hormone fluctuations, chronic fatigue, various gut issues, digestion problems. After doing research on my own and some common sense. Alcl stage and alcl treatment are unknown. 350-3380 I applied for social security disability and as approved. In the past few years i have been suffering from extreme pain in my right breast. Symptoms: fatigue, endocrine issues, depression, panic attacks, insomnia, joint pain and cognitive dysfunction. Link. Her face started to swell when she got cold. Rx meds: i guess i will list all that are prescribed many i have not able to take because sadly i cannot afford them anymore. Constant lower back pain (and right hip). The rheumatologist took blood tests and results showed i had an autoimmune disease known as scleroderma. I could no longer get out of bed and had to have assistance bathing and dressing. Link. Important information: i have been very diligent in following doctors protocols and have preferred diet and exercise over medication if at all possible. More than 10 numbers, contact manufacturer. Damaged/faulty implants have ruined my health and many aspects of my life. I come from a long line of healthy people who mostly live into their nineties. If I had been told that any of these possibilties, I never would have had them put in!!!!! 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 have been diagnosed with sjogrens, myalgia, low c4 and anemia. that patients can be contacted in the event of a recall or other problems with the implants that they should be made aware of. I only left the house for doctor appointments. I finally found out that this is the brand I have for about 10 years nowI just thought I was having symptoms of getting old, until I heard about BII.now I realize that every thing that is wrong with me I have read about on BII sites..Now, what do I do? It has been a year of feeling acutely ill. Then in 2011, i was diagnosed with a rare blood cancer. I will continue to receive services from the occupational therapist and the social worker. Ringing in my ears daily. Many test to follow. This is the date of my first cardiac ablation for persistent premature ventricular contractions (pvc). Weight began to plummet, as did blood pressure and just all over general malaise. No improvement with nsaids (multiple tried). Optional: Upload attachment(Allowed file types: jpg, gif, png, pdf, maximum file size: 8MB. Mastitis, cellulitis of the breast. After (b)(6) of lab work, my dad mentioned seeing a news broadcast about toxic breast implants. . The patient felt discomfort which she had not previously experienced. Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. I continue to have swelling in my hands and weakness in my upper arms, neck and back. 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. I had to have a double mastectomy in 2009 with immediate breast implants. I know many, many(over (b)(6)) women suffering with this same situation. dizziness (light headedness). =h48(!_)L K=%.R0-&S t88/ I know many women do whether they have had autoimmune illness before or not! 11. I couldnt breathe, thought i have heart attack. Implants placed under a mentor trial in 2004, in 2005 i had revision surgery all the right implant capsulized within six months. Using DoNotPay for assistance in resolving recall issues other than breast implants is just as easy. Medtronic and adrenal issues. Polycythemia vera rubra. Upload photographic evidence of your purchase and the product if you still have it. Patient suffered pain on the left side for the past year and it was getting worse. Please take these off the market. Not even a year later i am so ill and in pain i need three surgeries which will not reverse all thats happened. Esophagus is where it is stuck, it takes hours to get these disgusting chunks out of my throat and its exhausting. No patient information (name, phone number, email, date of birth) was provided, therefore no follow up was completed, and there is no additional information available. The patient reported to have several undisclosed illnesses within months of getting the implants put in. Link. Cultures were done, idc was called in and i had pseudomonas aeruginosa and serratia marcescens. Extreme fatigue, loss of concentration, memory loss, along with brain fog, confusion and cognitive dysfunction. This somewhat lessened some of my symptoms but i still felt sick like i was dying slowly. 9\?~=4fY[[x|2=(;/QVUTr4( Per the customer, the plastic wrapping the implant boxes was also damaged. The implant was removed from the field and a new implant was used for the procedure. Even though i was under a trial study, mentor never contacted me and i dont think the surgeon reported as per the agreement i signed. Around 2005, i started having raynauds disease which always affects my nipple and toes when cold. Due to memory issues and based on disclosure of history only, one doctor diagnosed dementia. The changes i have had in my body in the past 15 months have been so drastic for me. These are mentor memory gell 450cc breast implants still in me. It was reported that memorygel siltex round ultra high 455c (p/n: 3545455; l/n: 7374907-027) had a piece of fiber on it and it did not appear sterile. I have constant infections. 350-3310 Before sharing sensitive information, make sure you're on a federal government site. Link. Posting Date. Shortness of breath (feel like i cant catch my breath). Sit back and relax while we do the work. Here is some of the information you should first gather to file a claim associated with your Mentor saline implant recall. Link. I have breast implants since 1993. Link. 5 years ago. Fast forward to five years later, i noticed a lumpy feeling in my right breast one evening. Skin rashes only getting worse and slight fibromyalgia diagnosed by dr. (b)(6). 350-3290 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. 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. Was sent to podiatrist and rheumatologist. Loss of appetite, weight loss. Rushed to surgery for third time. I can walk short distances with the use of a cane; i still have to use an electric scooter or be pushed in a wheelchair if i have to stand for long or go very far. 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