350-1650 Swollen hands, tingling in the hands and arms when i bend my joints. Mentor Silicone Gel-Filled Breast Implants are devices with shells constructed from silicone elastomer. Autoimmune diseases are often caused by external reasons, and are not always hereditary. 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. They discharged me and less than 12 hours later I went to a different hospital. I developed raynauds syndrome, and symptoms that look like rheumatoid arthritis, but a rheumatologist tested my blood and it was negative for this condition. Mentor Textured Silicone 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. 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. I had smooth mentor memorygel breast implants placed under the muscle 2. Team of doctors at (b)(6) clinic couldnt figure out what was happening to me. The hospital has denied the mammogram caused the rupture but both at the same time is so obvious. (Unknown if it is Mentor saline or silicone). Chronic fatigue, weight gain, inability to be active. Link. Distributed in the states of NY, WI, CA, TX, CO, NC, NJ, OH, TN, RI, and IL. Saline-filled breast implants are firm to the touch while gel-filled implants mimic the feel of fat in a patient's body. Within the past 8 months i heard about breast implant illness, i do believe i suffer from it. UkEq5LuEBf&ei'FKNl, @HfoB}S#L +nj^yJnJ(k7D?$$$# I havent even had a cold for at least 2 years or more. The FDA had required this study to be done for 10 years, according to guidelines of the Approval Order in 2006, but the Final Reportwas submitted in year 6 of the study in 2012. A lot of my symptoms have improved or disappeared after removing the implants. Large Study:The follow-up rate was 20.1% at 7 yearsand the final report is on year 9 in 2015. I could no longer get out of bed and had to have assistance bathing and dressing. In March they took out my perfectly normal appendix, I remained in the hospital for two weeks after that surgery where I gain nearly 20 pounds in water weight and swelling, with severe abdominal pain. Immediately after removing the implants began seeing a new dr for help with this who after further lab studies diagnosed me with hashimotos thyroiditis which is an autoimmune disease more than likely caused by the endocrine disruptive toxins in the implants. Began with pain in joints/muscles of the neck, led to other infections and weakened immune system, followed by growing pain in joints and extreme fatigue. 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. Implants placed under a mentor trial in 2004, in 2005 i had revision surgery all the right implant capsulized within six months. I am hoping i will get better after explanting. The FDA issued final guidance, Breast Implants - Certain Labeling Recommendations to Improve Patient Communication in September 2020. The plastic surgeon performed what is called a dual-plane approach half under/half over the muscle to give a tear drop shape). 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. H\Pj0+tlI Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English, Prosthesis, breast, noninflatable, internal, silicone gel-filled, Code of Federal Regulations (CFR) Title 21 7.55. Ive been reading endless stories online. 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 I had the implants removed at the end of 2015. I have no clue when or how i did this. 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). Multiple attempts have been made to obtain clarification on catalog, lot number and manufacture site of the devices that were used during this procedure. 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. Hypothyroid, coughing, intolerant to heat and cold, new and persistent viral infections, candida, constant yeast infections. k-9(J((5*k?aT/SZ D z:Trx%(o8L?h{C5t*Q (Unknown if it is Mentor saline or silicone). The patient must be given the opportunity to initial and sign the patient decision checklist and it must be signed by the physician implanting the device. I have chronic candida overgrowth hormone fluctuations, chronic fatigue, various gut issues, digestion problems. What is your recommendation? Fatigue pressure on face (under eyes, around nose) constant headaches, tingling in hands and feet (fall asleep, drop things, difficulty opening things, typing etc). 350-3420 Link. (b)(6) of this year started a severe decline in my health. Link. Mentor Worldwide Historical Implant Data 1985 May 2018. No further information was obtained. I suffered from chills, hallucinations, elevated blood pressure, fatigue and diarrhea. 350-3310 I have night sweats, i get insomnia, i have a couple different autoimmune diseases that have come about. I was no longer able to work and was placed on disability. Health deteriorates i lose 25 pounds and blood tests in 2015 suggest cancer. Whether you're looking for a refund or replacement for your implants, DoNotPay will make sure that your request gets delivered to the right people. Constant fatigue, nausea, weight loss and ibs. SALINE-FILLED MAMMARY PROSTHESES WITH DIAPHRAGM VALVE. As of today, (b)(6) 2017, im taking cipro 500 mg twice daily, drain is still intact, takes me over 2 hours to bathe, dry my hair and dress, because im fatigued. Brain fog, anxiety, depression, numbness, sore, fatigue, loss of ability. Weekly b12 injections. Post-approval studies (PAS) are conditions of device approval. Since that day ive suffered the following abnormal weight gain, chronic fatigue, brain fog, diagnosed thrush, lack of energy, dry eyes, lack of concentration, dizziness, inflammation, dry skin and hair, estrogen imbalance. /f&b2jy|/ZS [=s Began with recurring upper respiratory infections, cellulitis infections, staph infections, lymphedema put on 100 pounds. The patient had the implants surgically removed on (b)(6) 2017, at which time the surgeon noted that the implants were leaking. Knee/joint pain. By this time, too, i began feeling malaise, and i then was weakened to the point of being unable to walk unaided. Have mentor breast implants. Within a year, i began to experience headaches, fatigue, chronic joint pain in left side of neck, shoulder, hip, knee, brain fog. in this way, she confirmed that it could be breast implant illness that i was suffering from. Breast implant labeling is provided to ensure a patient receives and understands the benefits and risks of these devices. I have had the implants since 1998, had them removed and put new ones in from mentor back in 2004, before the fda lifted the ban on implants. I am getting sicker and sicker. 5. Tingling and numbness in face, hands, and feet. In doing my research, i trusted the fdas recommendation that these were very safe implants. My implants were under warranty so mentor paid for a new set and most of the surgery. Chronic pain, chronic fatigue, cognitive dysfunction (brain fog, difficulty concentrating, word retrieval, memory loss, difficulty processing information), muscle aches, pains, and general weakness, joint pain, dry itchy eyes, easy bruising, loss of sex drive, inability to sexually perform, shortness of breath, night sweats, hormonal imbalances, tingling and numbness in arms, hands and fingers, cold hands and feet, metallic taste in mouth, nail cracking, splitting, no growth, skin freckling, increase in papules, edema, decline in vision, digestive and gastric issues, throat clearing, difficulty swallowing and choking feeling, anxiety, depression, panic attacks. )7:Evvc},,dK9%"Ty.73&X6H(TQzz?n7?"=O[U? I continue to have swelling in my hands and weakness in my upper arms, neck and back. 11. Customer Service. PMAs with Product Code = FTR and Original Applicant = MENTOR CORP. I am only (b)(6) and should not have any of these health issues. 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. No money and insurance will not cover? f1NW 350-3290 There i saw my right implant was completely ruptured. I have been to several drs and surgeons who thankfully acknowledge implant illness and i am on my way to having implants removed next month. !C`2D0NzI%jFCBZZ#XJA|r Y^kb?3q4 Developed anxiety and uncontrolled vaso-vagal responses. I happened to notice that one of my breast implants (from breast cancer in 2000) had gone flat. 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. Hair thinning and lost. MemoryGel Breast Implants provide a soft, natural feel desired by patients. Update on the Safety of Silicone Gel-Filled Breast Implants, MemoryShape and MemoryGel Post-Approval Study. I had mris to check for issues with neck- diagnosed at first as herniated discs but then as arthritis. Loss of appetite, weight loss. The product was a silicone gel breast implant. 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? 13. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. I even developed (b)(6) 3 weeks after the surgery under my armpit, which ive never had. The symptoms are all still there and the issues persist despite medication and extreme lifestyle and diet overhaul. Re-Op Study: This studywill collect data when a participant from the original Large Post-Approval Study with MemoryGel breast implants requires a secondary procedure/reoperation. I experienced horrific pain, consulted with pcp who ordered x-rays that showed no rupture. Link. Link. I finally had them removed today. Each implant is filled with Mentor's cohesive gel, which holds together uniformly and retains a natural give that better resembles breast tissue. Link. * In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients. They had migrated to under my arms!!!!! Palpitations. Over the next 3 years my health steadily declined with unexplained symptoms. I am being treated for this currently. No improvement with nsaids (multiple tried). I even contacted mentor and the fda via email before and neither seemed to care. Believe my silicone breast implant was ruptured after a mammogram. My medical bills and trips to hospitals are out of control. 350-2375 I would give anything to have my life back. Have various test. Link. The patient was implanted with mentor smooth round gel mammary prostheses on (b)(6) 2005. After doing research on my own and some common sense. I experience brain fog, trouble recalling words and im only(b)(6). I have chronic widespread pain and digestive trouble. My right mentor high profile silicone breast implant shell has completely disintegrated, implanted in 2012. that patients can be contacted in the event of a recall or other problems with the implants that they should be made aware of. Some days cant get out of bed. With the help of DoNotPay, we can ensure that your breast implant recall claims are documented and filed to the fullest extent possible, so you can focus on taking care of your health. Implants should be taken off the market, they are so hazardous to our health. 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. I have mentor breast implants that were placed in (b)(6)2007. Mentor silicone implants caused a slew of health issues. Muscle pains and joints. 350-2275. Link. Patient took advil, various muscle relaxants, heat and other remedies. Link. Unknown if it is Mentor saline or silicone: Mastitis, swelling, nodules and varius other illness. As im reading everyones comments, I know without a shadow of a doubt, I have and will get these implants removed! MENTOR Breast Tissue Expanders. The products included in the recall are: 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 Medtronic and adrenal issues. (Unknown if it is Mentor saline or silicone). Per patient, the physician believes the right device was defective. Here are some examples of our many recall request assistance programs. I am having a had reaction to my mentor silicone memory gel implants that were placed under the muscle three years ago. Link. I was diagnosed with alcl in 2016. I still have most symptoms, but many have improved at least slightly. Link. 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. The health consequences of a ruptured silicone gel breast implant have not been fully established. Link. Since I had them implanted my body has changed tremendously from brain fog, GI issues with severe bloating. I do not smoke cigarettes, and rarely ever drink any alcohol. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Risks and Complications of Breast Implants, Medical Device Reports for Systemic Symptoms in Women with Breast Implants, Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma, Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), Things to Consider Before Getting Breast Implants, Breast Implant Postmarket Safety Information, FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants, Breast Implants - Certain Labeling Recommendations to Improve Patient Communication, Saline, Silicone Gel, and Alternative Breast Implants guidance, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders. Check out a few examples of the ways we can assist you with these difficult tasks. 12. r2c=nf"{*!5;/[{8F7)/Z}}o_=T*u 4+ )Z9B I started to have rapidly degenerating joints and have had 5 ortho surgeries including joint replacements. I believed the fda and the plastic surgeon. The purpose was to evaluate the association between Mentor MemoryShapeSilicone Gel Breast Implants and five rare disease outcomes: rare connective tissue diseases, neurological diseases, brain cancer, cervical/vulvar cancer and lymphoma. Tell us about your purchase, including the product name, brand, store you purchased the item from, price, and date of purchase. 6. 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. My body couldnt sweat couldnt get rid of toxins. q@8mhD";BN"z\h[-1k90p UpK&uEO`W4]76 $gQsB#ZYWG[1!EMd[O'teY3c[UhgE?_u `6 MENTOR - Contact Us PATIENT INQUIRIES AND WARRANTY INFORMATION If you are a patient, please contact us using the resources below for additional information about breast augmentation, breast reconstruction and breast implants.

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