I started having sensitivity to foods which i never had before and the foods cause pvcs. Migraines, blurred vision, dizziness, chest pain, gallbladder stopped working without stones, chronic fatigue gastritis, chronic epstein barre, hashimoto thyroid, lyme disease and more. I was no longer able to work and was placed on disability. My medical bills and trips to hospitals are out of control. Learn More. Site of lymphoma: right side. I was told these implants were inert and safe for implantation and that was clearly not the case for me. 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 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. 'D))2eYhkE1yj{Y0\. 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. Saline-filled breast implants are firm to the touch while gel-filled implants mimic the feel of fat in a patient's body. 13. For our MENTOR Breast Implants, if a rupture occurs within 10 years of surgery, you will also be eligible for up to $3,500 in nancial assistance for surgical costs. There was no patient contact reported. Have mentor breast implants. It was reported that a (b)(6) year-old female underwent primary augmentation surgery using mentor silicone implants. I had these mentor silicone implants placed in 2007. MENTORMemoryGelBreast Implants provide the soft, natural feel patients desire and are available in a wide range of sizes and profiles to fit the patient's body. None of them would even acknowledge it because they said all implants are fda approved and then would change the subject. The alarming conflict of interest in the manufacturers sponsoring the studies and in the plastic surgeons handling the study is astounding. (b)(6) of this year started a severe decline in my health. Damaged/faulty implants have ruined my health and many aspects of my life. endstream endobj startxref The implant packaging was opened and inspected on the sterile field table in the or. I started to have rapidly degenerating joints and have had 5 ortho surgeries including joint replacements. The products included in the recall are: I have a lot of health issues because of them. Here is some of the information you should first gather to file a claim associated with your Mentor saline implant recall. Link. The hospital has denied the mammogram caused the rupture but both at the same time is so obvious. Link. Since the removal of the implants, i have had 2 addl reconstruction surgeries including a latissimus flap. 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. Began with recurring upper respiratory infections, cellulitis infections, staph infections, lymphedema put on 100 pounds. I have developed severe symptoms over the past two years to include: worsening peripheral neuropathy, muscle/joint/bone pain, and weakness, tremors, dizziness/blackouts, seizures, severe fatigue, mental confusion/forgetfulness, difficulty speaking, went into acute liver failure twice, weakened immune system/recurrent infections, rashes, wounds that wont heal, mood changes, heart palpitations, etc. **1 y* 5 post implants. I am so tired of missing out on life due to the way I feel. I have had recurrent bacterial vaginosis, utis, black-ish green discharge form breast nipples (tested and came back as staph infection). These devices are not safe. The nipples were 99% erect and felt swollen for most of the time. I feel weak more as time goes by. Im disappointed that the fda allowed mentor to complete their own studies and so easily allowed them back on the market after only 3 years so that this implant company and plastic surgeons could make money. Link. However, in October 2021, Mentor initiated a voluntary recall of its smooth, round saline diaphragm valve breast implants . I had mentor cohesive gel implants placed. Link. Hair thinning and lost. In 2014 i started to get swelling in my fingers and toes. in this way, she confirmed that it could be breast implant illness that i was suffering from. I was wondering what steps to take to ensure that i was healthy and safe. The implant was labeled as 325cc but the implant had volume of 375cc. Link. I have been extremely sick about 1 year after surgery. 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. During this procedure, the surgeon noted that the right breast was discolored (brown). 5. I researched and found tan excellent plastic surgeon. This somewhat lessened some of my symptoms but i still felt sick like i was dying slowly. }_t}yOi*/ )BY|M ty$'^T8a*7ffDUd8IiQq|VV/_N\rHpSVwtL|8QTFTT{=x?+9R2g*ORG Recalling Firm. 12. Mri confirmed that the breast implant had ruptured. I am ASAP to get my life back! Dry hair, dry skin, dry mouth, and dry nails. Link. I thank the rheumatologist for validating the fact that the implant could be the cause. I couldnt breathe, thought i have heart attack. Link. A lower risk of complication is rupture. Mentor stands by its textured implants and says the cancer is "rare" with its product. I started in (b)(6) going to doctor. Team of doctors at (b)(6) clinic couldnt figure out what was happening to me. The patient reports that the device was explanted on (b)(6) 2017. (Unknown if it is Mentor saline or silicone). Manufacturer requested implant and packaging directly from or team to investigate. 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. Implants robbed me of a year of my life!. Best Way to Get a Refund From Sunscreen Recalls, The Easiest Way to Claim the Neutrogena Sunscreen Recall, Best Way to Make Claims on Vehicle Recalls by VIN, What To Do Next If You Have Been Affected By The Philips CPAP Recall, Claim a Refund for Blue Buffalo Pet Food Recalls Today, The #1 Method to Claim a Refund for Rachael Ray Dog Food, How to Claim Your Kia Forte Recall Repair in 5 Easy Steps, The Best Way to Claim a Boon High Chair Recall, Claim a Refund for Clean N Natural Hand Sanitizer Recalls, All About GE Dehumidifier 30 Pint Recalls, How To Make A Claim For The Germ-X Hand Sanitizer Recall, How to Make a Hatfield Shotgun Recall Claim, How to Pay Your Houston Water Bills Online Hassle-Free, How to Remove My Case From The Internet Instantly, How to Recover Your Forgotten Workday Password Hassle-Free, Sending Money to an Inmate Has Never Been Easier, Credit Card Dispute Letter Template That'll Get Your Money Back, Mentor Saline Breast Implants (2021-09-30), General Public, Healthcare Professionals, Hospitals, Contact your doctor for medical advice or an appointment, Contact your plastic surgeon for advice or an appointment, Contact the manufacturer for recall claim procedures, Collect all documents outlining procedures associated with your implant recall, Collect all documents listing the costs of recall of your breast implants, In December 2001, Mentor Worldwide LLC submitted pre-market approval for MemoryGel breast implants, In December 2003, the FDA approved MemoryGel implants, September 30th, 2021, Health Canada initiated a Mentor breast implant serial number recall, Mentor saline breast implants with specific serial numbers may have a weakened structural defect causing deflation, Mentor Texas LP. 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! I was a very healthy, active person up until all of this happened. 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. 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. /f&b2jy|/ZS [=s Lived with 20+ symptoms for over 5 years. As soon as 4 months after implantation i had an emergent visit to the er for vertigo persistent vomiting and dizziness. Copyright 2016-2022 BreastImplantIllness.com. It was reported that packaging for implant sm mpp gel 400cc (p/n: 3504001bc; l/n: 7402435-060) had hole in it. The health consequences of a ruptured silicone gel breast implant have not been fully established. From that time on, i developed more and more symptoms that piled on top of each other. Ongoing recurrent infections. Besides seeing my primary care physician, i have seen a neurologist, rheumatologist, holistic/functional medicine, gynecologist, dermatologist, psychiatrist, therapist, chiropractor and have tried massage therapy, acupuncture, sauna, and more recently i saw a doctor at (b)(6) for heavy metal issues. Unknown if it is Mentor saline or silicone: Mastitis, swelling, nodules and varius other illness. This question is for testing whether or not you are a human visitor and to prevent automated spam submissions. Link. Mentor strongly recommends that all patients receiving silicone gel-filled . 350-2225 r2c=nf"{*!5;/[{8F7)/Z}}o_=T*u 4+ )Z9B 350-3310 I was diagnosed with hashimotos thyroiditis 3 years ago. Have had multiple visits to the ent and walk in clinic. Updated labeling to communicate long-term study results is pending for all implants in this table. Choose whether you have the capacity to return the item or not. After being implanted with silicone breast implants (cohesive gel by mentor) i became incredibly sick and my body started having a six-year downward spiral of auto-immune issues, endocrine issues, and adrenal dysfunction. Dense breast tissue was confirmed by ultrasound. Redness all over my body. My personal aide and the nurse have stopped coming now as i am finally showing signs of recovery. 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. I had mentor silicone breast implants in (b)(6) 2007. Researching implant serial numbers and tracking down your Mentor breast implant provider takes time and effort. It was reported that (b)(6) the female patient underwent primary breast augmentation surgery using mentor gel implants in 2000. In 2011 there was an update on the findings (Update on the Safety of Silicone Gel-Filled Breast Implants). These were conditions of FDA approval and were required by theApproval Order. Have had blood tests where discovered i had thyroid issues and then found out i had hashimoto. Updated silicone gel-filled breast implant rupture screening recommendations. Had breast augmentation in (b)(6) 2013. I experience brain fog, trouble recalling words and im only(b)(6). 6. I had the breast implants removed on (b)(6) 2015 and began the process of detoxing the chemicals and heavy metals that are in silicone gel breast implants. But since the surgery i feel like my lymph nodes are constantly swollen and keep struggling to fight off infections and colds. UkEq5LuEBf&ei'FKNl, @HfoB}S#L +nj^yJnJ(k7D?$$$# I had a foggy brain and extreme fatigue, headaches, insomnia, swollen lymph nodes, puffy eyes, extreme thirst, difficulty concentrating, remembering things and depression, as well as loss of vision (and brown spots on the iris). (1/5/17). Multiple attempts have been made to obtain more event details, however, no additional information has been made available. Chronic fatigue, weight gain, inability to be active. Mentors failure to address these concerns and comply with its post-approval study requirements is a violation of the firms pre-market approval order., FDAs warning letter to Mentor Worldwide LLC (Mentor). The patient sought treatment from several physicians, who concluded that the implants were responsible for patients condition. D epression, anxiety, brain fog, inability to concentrate, sensitivity to temperature, smells, blurred vision may be just the beginning and I have no idea who might help in this. Anaphylactic symptoms. I have been on a detox diet since (b)(6) 2016. 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. Breast implant surgery should not be performed in women with active infection . HV]o:}5$[:h{qm:HnE%e:$b`\Y/{h}0mW.9Ri 8RY2 (zWrix{)"j {CDEDJ,$vdTZ + J->5 A>~O,UZkJa]fZ9`=~G7^fcuX# Trying to get original doctor surgeon to release my medical records. I began having rheumatoid symptoms inflammation, huge knots popping up in various joints, pain on level 10. A lower risk of complication is rupture. Abnormal blood test results since 2012. Rheumatologist said i am at high risk for lymphoma. FDA Documents: Approval Date: November 17th, 2006 Recalls Patient also had delayed wound healing, infection, lymphadenopathy on the left side. Link. There should be some kind of warning about the dangers of breast implants. 350-3420 5. 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