mentor memory gel implants recall
I have learned that the mentor company product was approved but was supposed to complete a 10 year study that has now been cancelled. I lost 20lbs of muscle during this above-noted period, as my arm, leg and rear muscles atrophied, resulting in me being totally debilitated. Shoulder and neck pain, pain under my rt rib. As time continues to pass, more symptoms seem to be showing up. I have breast implants since 1993. Link. I developed raynauds syndrome, and symptoms that look like rheumatoid arthritis, but a rheumatologist tested my blood and it was negative for this condition. No one had any answers for me. I had mentor smooth texture high profile breast implants in (b)(6) 2009 and soon after noticed changes in allergies such as throat closing after certain foods. So many women are sick and get better after explant. Cognition problems, neurological issues. 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. Insomnia, feeling dizzy, or faint, almost blacking out (everything goes dark and i see stars). 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. Updated labeling to communicate long-term study results may not be available for all implants in this table. Link. The patient felt discomfort which she had not previously experienced. 4. Mentor Worldwide, LLC. There are 20,000 of us there with the same stories. In 2013, American Society of Plastic Surgeons (ASPS) commissioned a systematic literature review to be conducted by Tufts Center for Clinical Evidence Synthesis, funded by three breast implant sponsors, and the advisory board approved the final report on 8/1/2014. Within a year, i began to experience headaches, fatigue, chronic joint pain in left side of neck, shoulder, hip, knee, brain fog. 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. Around 2005, i started having raynauds disease which always affects my nipple and toes when cold. 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. Irving TX 75038-3524. (Unknown if it is Mentor saline or silicone). I dont even know how to put it in words. waiting for scheduled explant and lymphadenotomy when i will be hospitalized. I was extremely healthy at time of the implant surgery and was told these were fda approved and very safe. Adjunct Study Final Report for Mentor's MemoryGel Silicone GelFilled Breast Implants, 02 November 2012. In 1998, i had a reconstructive surgery and mentor brand, textured, silicone implants were implanted. Night sweats. Looking at list of explant doctors and none in my state, neither would insurance cover this out of state or without more serious symptoms as are described here. Smooth surfaced implants are not affected by this recall. Was immediately put on meloxicam for inflammation. I couldnt breathe, thought i have heart attack. My doctor said there is nothing that can be done to prevent or fix the deformity once the implants are removed. Toxic shock symptoms, corrective tissue disease, vision issues, headaches, nose bleeds, recurring pneumonia. Right implant was found with thick fibrous capsule as well as intracapsular leak upon removal. Please help me before i lose my life. By this time, too, i began feeling malaise, and i then was weakened to the point of being unable to walk unaided. 'D))2eYhkE1yj{Y0\. She also had memory problems, fogginess, tinnitus on the left side, headache, joint pain, cold. Dry hair, dry skin, dry mouth, and dry nails. Had breast augmentation done. I feel weak more as time goes by. More than 10 numbers, contact manufacturer. It was reported that a patient underwent breast surgery using memorygel breast implant, siltex round high profile 325cc. I am convinced that all of my problems stemmed from the holes in them. Link. I was unable to walk or open windows or cupboards. I have 35 symptoms of Breast Implant Illness. I know many women do whether they have had autoimmune illness before or not! Link. Five years of medicating my body when it was trying to say please get these out of me. Researching implant serial numbers and tracking down your Mentor breast implant provider takes time and effort. I researched and found tan excellent plastic surgeon. The left was adhered to my ribs!!!!! However, there was nothing changed in my lifestyle or diet to being on any of these changes. 350-3310 Over the next 3 years my health steadily declined with unexplained symptoms. My right mentor high profile silicone breast implant shell has completely disintegrated, implanted in 2012. MENTOR Warranty Had vertigo for over a year, tinnitus, debilitating fatigue, depression, anxiety hair loss, weight gain and loss for no apparent reason, heart palpitations and chest pain, rashes, shingles x3 over the past year. I continue to have swelling in my hands and weakness in my upper arms, neck and back. I have a Mentor memory gel smooth round high profile implant on my left side after a mastectomy, implanted on 8/1/2016. 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. Heart palpitation, swollen and tender lymph nodes in breast area, underarm, throat, burning sensation around breast implant and arm pit, bladder pressure pain. Swollen hands, tingling in the hands and arms when i bend my joints. 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. After approximately 1. Had frozen shoulder. 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. 1 MENTOR Breast Implants are backed 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. Link. I have a lot of health issues because of them. HVmo6_qHDE(NqD0dJ!R[IY[>L(;uzgYf7Y>l2iLY2$H! Dermatologist and allergist were seen without relief. I have many chronic illnesses that i never had before including: pain in my breasts, joints, bones, arthritis, migraine headaches and dizziness, aversion to smells and taste, dry skin, canker sores in mouth, throat and swallowing problems, chronic fatigue, memory problems, gerd, insomnia, ear ringing, restless leg syndrome, forgetfulness, anxiety and panic attacks, swelling, inflammation all over body, weight gain in upper extremities. Link. Its never been ending and i cant get medical assistance to have them removed. Using DoNotPay for assistance in resolving recall issues other than breast implants is just as easy. Now i am homeless. 304 0 obj <> endobj MemoryShape PostApproval Cohort Study (formerly Contour Profile Gel Core Study) Final Clinical Study Report . 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. I could not take myself to these appointments. 350-2225. Link. Link. 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. From that time on, i developed more and more symptoms that piled on top of each other. No deflation were found on both devices. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. 5 years ago. Irvine, Calif., (January 13, 2021) - Mentor Worldwide LLC, the number one global brand in breast aesthetics, and part of . This final guidance contains recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants. 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 To be able to walk and have energy again, and hopefully for the arthritis symptoms to diminish. Link. 350-2300. I was able to return to a mostly normal life, although the symptoms never went away. Distributed in the states of NY, WI, CA, TX, CO, NC, NJ, OH, TN, RI, and IL. (Unknown if it is Mentor saline or silicone). 13 Feb 2020. They continue to get worse. The shell is filled with MemoryGel , Mentor's proprietary formulation of medical grade silicone gel, and is constructed of successive cross-linked layers of silicone elastomer. Breast tissue was not sent for histology at that time. 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. I have pictures, notes and many bills. The mammogram film showed the bursting of the implant. Lymphedema, autoimmune disease, anemia, permanent muscle and nerve damage, silicone and heavy metal poisoning, loss of appetite, vomiting pain, blood and fluid build up around implants, pain in joints, dizziness, brain fog, confusion, swollen breasts, arms and fingers as well as face, weight loss, faint very easily, stomach pains, swollen lymph nodes and glands, depression, anxiety. I was no longer able to work and was placed on disability. The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates. She became very ill and had been sick during a business trip, with a fever, swollen left breast and lymph node infection. I fortunately found a (b)(6) support group for women with breast implant illness, what i believed to have. Read Mentor's full statement below: "Nothing is more important to Mentor than the health and safety of the . Then i got very sick in 2012 when i got a diagnosis of polymyalgia rheumatica a crippling autoimmune disease seen in senior adults. Mentor Textured Silicone Implants. 350-3230 I started in (b)(6) going to doctor. I am having a had reaction to my mentor silicone memory gel implants that were placed under the muscle three years ago. 5. I have heart issues, fatigue, high metal to city that can lead to significant cardiac issues. 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 breast implants on (b)(6) 2016. 350-2300 Went through chemo then had a stem cell transplant in (b)(6) 2016. Fatigue was addressed with a suggestion to get more sleep. Could barely walk. These are not safe. I even contacted mentor and the fda via email before and neither seemed to care. On (b)(6) 2015 i had woke up to a horrible pain, ended up capsular contracture grade 4 (baker), then ended up ruptured right breast tissue and implant as well as the following: fatigue or chronic fatigue, cognitive dysfunction (brain fog, difficulty concentrating, word retrieval, memory loss), muscle aches, pain, and weakness, joint pain and soreness, hair loss, dry skin, eyes, mouth, hair, weight gain or weight loss, easy bruising and slow healing of wounds, temperature intolerance, low libido, ringing in the ears, heart palpitations, photosensitivity, shortness of breath, metallic taste in the mouth, oral thrush (white tongue), night sweats, skin rashes, insomnia, estrogen/progesterone imbalance or diminishing hormones, swollen and tender lymph nodes in the breast area, underarms, throat, neck, or groin, tingling or numbness in the arms and legs, burning pain around the chest wall or breasts, cold and discolored hands and feet, foul body odor, muscle twitching, dehydration, frequent urination, chronic neck and back pain, nail changes (cracking, splitting, slow growth, etc), skin freckling, pigmentation changes (darkening or white spots), or an increase in papules (flesh colored raised bumps), edema (swelling) around eyes, premature aging, decline in vision or vision disturbances, liver and kidney dysfunction, digestive and gastrointestinal issues, food intolerances and allergies, smell or chemical sensitivities, new or persistent infections viral, bacterial, and fungal (candida), reoccurring sinus infections, throat clearing, cough, difficult swallowing, choking feeling, chronic inflammation, feeling like you are dying, headaches, dizziness and migraines, mood swings, emotional instability, anxiety, panic attacks, suicidal thoughts, depression, hypo/hyper thyroid symptoms, hypo/hyper adrenal symptoms, symptoms or diagnosis of fibromyalgia, symptoms or diagnosis of lyme, common autoimmune disease, 33 different metals and chemicals including silicone. Link. Cant wear socks or shoes only flip flops. 9\?~=4fY[[x|2=(;/QVUTr4( MENTOR Breast Tissue Expanders. 350-2275. Posting Date. 350-1635 They were smooth, round, and saline, 270 on one side and 300 on the other. There was no patient contact reported. A sponsors failure to comply with any post-approval requirement may be grounds for withdrawing approval. FDA. 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. Patient took advil, various muscle relaxants, heat and other remedies. Summary of the Safety and Effectiveness of Mentor's MemoryGel Silicone GelFilled Implants in Patients who are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, or Revision. I couldnt think clearly, and i could not sleep. It was reported that packaging for implant sm mpp gel 400cc (p/n: 3504001bc; l/n: 7402435-060) had hole in it. Very weak, couldnt walk a flight of stairs. Implants placed under a mentor trial in 2004, in 2005 i had revision surgery all the right implant capsulized within six months. Tingling hands and feet, cold hands and feet, tempt, intolerance, light sensitivity and noise sensitivity. 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. I also thought maybe i wouldnt have all the adverse effects with silicone as i did with saline (thought maybe it was due to mold). In (b)(6) 2016, the patient underwent surgery and the mentor memory gel implants were removed. I started having sensitivity to foods which i never had before and the foods cause pvcs. Cause 2. 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.
