The shell is filled with MemoryGel, Mentor's proprietary formulation of silicone. April 2013. 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 . 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. The list goes on. Link. I started in (b)(6) going to doctor. Avoid delays that will only cause undue stress, worry, or possibly affect your health by using DoNotPay. 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. Mentor silicone implants caused a slew of health issues. It is one of 2 ablations in less than a year. Had breast implants put in and have had failing health since. Mastitis, cellulitis of the breast. Plastic surgeon does not know if or when surgical correction can take place. 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. Some of the symptoms are, joint pain, muscle pain, blurry vision, ringing in the ears, hair loss, ibs, chronic fatigue, memory loss. They also recommended ultrasound at the discretion of the radiologist. Link. 13. Rushed to surgery for third time. Second, the FDA approved new labeling for all legally marketed breast implants that includes: The breast implant manufacturers have posted the updated device labeling to their websites. I am the poster child of healthy. Multiple attempts have been made to obtain more event details, however, no additional information has been made available. Sometimes cant even have a bra touch it. Link. Focus Group Study: This study used 35 women to evaluate how patients understood the safety and labeling brochures. Link. Then depression and daily anxiety became an issue. By this time, too, i began feeling malaise, and i then was weakened to the point of being unable to walk unaided. f5/@aGp/)gd 3Li"'7eXqZ')n'4q`_;*Wa$.D&?HW/ SB( a|jg!Fqm. I hadnt been contacted for several months because the breast tissue itself looked normal. I am hoping i will get better after explanting. 3. In 2019 I started experiencing severe lower abdominal pain that sent me to the emergency room several times. From the middle of (b)(6)(the date my plastic surgeon explanted the implant), i became so debilitated that i could no longer walk. Redness all over my body. 3 Very weak, couldnt walk a flight of stairs. Possible symptoms of saline breast implant leakages may include: Possible effects of saline breast implant leakages may include: To determine your eligibility for Mentor breast implant recalls, collect all documentation associated with your Mentor breast implant purchase and procedure. FDA Recall. Each implant is filled with Mentor's cohesive gel, which holds together uniformly and retains a natural give that better resembles breast tissue. We have helped over 300,000 people with their problems. I had breast implants on (b)(6) 2016. 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. I only left the house for doctor appointments. Link. The recommendations in this guidance supplement the recommendations in the FDA's Saline, Silicone Gel, and Alternative Breast Implants guidance, issued September 29, 2020 superseding the prior version dated November 17, 2006. Choose whether you have the capacity to return the item or not. Another said i was an interesting case as tests for memory mostly showed fairly bad short term memory. Muffled ears like swimmers ear. Link. 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 it looks like thats what i am coughing up sometimes like i said its extremely sticky. Esophagus is where it is stuck, it takes hours to get these disgusting chunks out of my throat and its exhausting. Her face started to swell when she got cold. 6. Alcl stage and alcl treatment are unknown. (Unknown if it is Mentor saline or silicone). Damaged/faulty implants have ruined my health and many aspects of my life. Link. Brain fog, dizzy, memory loss, nausea, seizures, blurred vision. Health deteriorates i lose 25 pounds and blood tests in 2015 suggest cancer. Link. Multiple attempts have been made to obtain clarification on patient information as well as catalog, lot number and manufacture site of the devices that were used during this procedure. Told me to go to (b)(46 clinic. The .gov means its official.Federal government websites often end in .gov or .mil. No one had any answers for me. The recall came after the FDA released data in 2019. 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. Link. Fatigue was addressed with a suggestion to get more sleep. Caused autoimmune diseases ana connective tissue diseases. She had hashimotos disease, chronic fatigue, brain fog, possible alcl according to the physician. April 2013. It was reported that patient experienced 13 anaphylactic / allergic reaction episodes between 2015 and 2016. My doctor said there is nothing that can be done to prevent or fix the deformity once the implants are removed. Cultures were done, idc was called in and i had pseudomonas aeruginosa and serratia marcescens. Link. I couldnt breathe, thought i have heart attack. Feet red swollen to deformity. However i had in 2010 began to be diagnosed with many more autoimmune disorders. Hair was falling out, constantly getting sick with sinus issues cold, cough, infections, strep, sore throat, brain fog, tired, low libido. Loss of interest and pleasure in doing activities. 39: My medical bills and trips to hospitals are out of control. Contact the relevant medical authorities who conducted the surgery and request an updated Mentor breast implant recall information. This final guidance contains recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants. My breasts were so deformed from the explantation (muscle had attached to the breast tissue and every time i flexed it pulled my breasts inward) that i decided to have new implants put in to see if it would help the deformity and improve my self confidence. Pain is intense, particularly in the mornings or after sitting for a while. My physical therapist told me i must maintain an exercise program that he prescribed for me. Only effects hip and shoulder joints. I was given iv cipro for several days. H\j@}l/ `t They are supposed to last 10 years. I am convinced that all of my problems stemmed from the holes in them. Link. The implant packaging was opened and inspected on the sterile field table in the or. 350-2425, SMOOTH ROUND HIGH PROFILE SALINE-FILLED MAMMARY PROSTHESIS, 350-3210 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. Post-approval studies (PAS) are conditions of device approval. I have gone through all my savings trying to get better! 350-3310 The following section provides links to the approved labeling and the progress of expected labeling supplements. I was convinced that the implants had ruptured even though it didnt show up. 304 0 obj <> endobj I requested an mri and it was shown both implants were ruptured. I am ashamed of the mentor company because of the old and new medical research the proves these implants ar highly toxic. At present, i cannot sit for long, tire easily and cannot drive far. Each implant is filled with the Mentor proprietary cohesive gel that holds together uniformly and retains a natural give that better resembles breast tissue. I know many, many(over (b)(6)) women suffering with this same situation. 350-1635 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. Also. My body couldnt sweat couldnt get rid of toxins. No deflation were found on both devices. Dry eyes (difficulty crying) dry mouth (always thirsty) dry throat (difficulty swallowing pills, food gets stuck) gel hoarse, especially in evenings. This has been a terrible month and year for me. Cant wear socks or shoes only flip flops. One of the first signs that something was wrong was in early (b)(6) 2009. Have had multiple visits to the ent and walk in clinic. In 2017, i chose to have implants removed. Here are all the ongoing symptoms: migraines, anxiety, fatigue, temperature intolerance, sensitivity to smells, burning pain in breasts, inflammation in breasts, weakness, chronic back pain, whole body dryness, pigment discoloration, blurred vision, word retrieval, concentration, and rapid weight gain. Link. Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruc. 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. In the past few years i have been suffering from extreme pain in my right breast. I the implants were never soft and felt artificial. I have learned that the mentor company product was approved but was supposed to complete a 10 year study that has now been cancelled. 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. 3 Now i am homeless. More than 10 numbers, contact manufacturer. %PDF-1.7 % Fast--You don't have to spend hours trying to solve the issue, Easy--You don't have to struggle to fill out tedious forms or keep track of all the steps involved in solving your problem, Successful--You can rest assured knowing we'll make the best case for you. Link. Symptoms: fatigue, endocrine issues, depression, panic attacks, insomnia, joint pain and cognitive dysfunction. Now i have white-ish pus discharge (fungal infection), extreme pain/burning in both breasts as well as numbness/tingling/burning sensation in arms/shoulder, grade #4 capsular, contracture, trouble breathing properly, memory loss/brain fog, blurry vision, swollen throat lymph nodes, loss of motion in both arms, major teeth issues due to implants, leaky gut/ibs, extreme anxiety and depression, bed ridden, muscle pain, unknown opage spots on breast ultrasound, candida issues/fungal issues/bacterial issues, muscle loss, extremely achy joints, massive fatigue, sinus issues, migraines. im so frustrated and depressed about the last 12 years of feeling horrible and i wish i never decided to get new implants. Insomnia, feeling dizzy, or faint, almost blacking out (everything goes dark and i see stars). For more information, see FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants. I told my plastic surgeon about it, said i was concerned but he brushed it off and said it was not related, even though it began right after implantation. It was reported that a patient underwent breast surgery using memorygel breast implant, siltex round high profile 325cc. I am carefully monitoring my progress but something needs to be done about this as i am one of thousands upon thousands of women who have all had this same problem. Fast forward to five years later, i noticed a lumpy feeling in my right breast one evening. It was reported that a patient (unknown age and gender) with mentor breast prostheses (unknown lot # or catalog #) was diagnosed with alcl (diagnosis date unknown). =h48(!_)L K=%.R0-&S t88/ Update on the Safety of Silicone Gel-Filled Breast Implants, MemoryShape and MemoryGel Post-Approval Study. I have experienced fatigue, joint pain (hips), muscle soreness, red and sore eyes, weight gain, inability to take deep breaths, inability to lose weight , double vision and trouble recalling words. I am reporting now in the hopes that eventually these implants will be removed from the market and further restrictions imposed on any implantable device put in the human body. 350-1660, SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT W/DIAPHRAGM VALVE, 350-2200 350-2400 Pathological evaluation of the patients lymph nodes, removed during the explantation surgery, revealed reactive histiocytosis which is associated with silicone leaking from the prostheses. hb```l@(0>.JO;%.mP'cGGE[GCKGGG>aS4FeX#aD{9L'0baZ\C@Ib @w?Vf . 5 post implants. I was diagnosed with alcl in 2016. The patient had a mammogram done on 10/20/2015 that showed some micro calcifications in the left superior breast and recommended patient attempt to obtain prior mammogram images for comparison and for additional imaging (spot magnification views) to evaluate the micro calcifications. The patient reports that the device was explanted on (b)(6) 2017. I was extremely healthy at time of the implant surgery and was told these were fda approved and very safe. I have been to several doctors and specialists over the year with no help or definite answers. Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. Since this event involves device sterility and could have led to an adverse event or serious injury, it is considered serious and mdr reportable. As soon as 4 months after implantation i had an emergent visit to the er for vertigo persistent vomiting and dizziness. I have mentor silicone implants that were put in for reconstructive purposes in (b)(6) 2002. Multiple attempts have been made to obtain clarification on this event. a few months later things went downhill fast! 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. The symptoms are all still there and the issues persist despite medication and extreme lifestyle and diet overhaul. This began to get out of hand this (b)(6) and i began to research to figure out what was going on. If you purchased the item online, enter your transaction details and payment method as well. Up until getting implants i never had any significant health problems. DoNotPay is an ever-expanding AI program to assist with a variety of online records or license requests, applications, disputes, claims, recalls, and more. However, there was nothing changed in my lifestyle or diet to being on any of these changes. Device description with a list of specific materials in the device. 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. endstream endobj 310 0 obj <>stream Toxic shock symptoms, corrective tissue disease, vision issues, headaches, nose bleeds, recurring pneumonia. At this point, though, i really just want to feel healthy again and get these toxic bags out!. Implant provides the natural feel patients desire with increased form stability to shape the breast. Link. Research needs to be done. Seven years ago i went from my lovely, natural b-cup to silicone (mentor memory gel) d-cup breasts. I would not recommend implants to anyone. The implant was labeled as 325cc but the implant had volume of 375cc. Team of doctors at (b)(6) clinic couldnt figure out what was happening to me. 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. Mri confirmed that the breast implant had ruptured. The surgery was on a thursday morning, and i needed a wheelchair by this time. MentorMemoryShape, MemoryGel, and Memory Gel BOOST implants are recommended for augmentation patients who are at least 22 years old, while the saline breast implants are indicated for patients who are 18 years and older. I finally had them removed today. 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). I had mentor silicone implants in 2012. It was reported that a (b)(6) female patient underwent bilateral breast prostheses implantation with mentor gel implants on (b)(6) 2013. In the event of an unexpected qualifying deflation of a MENTOR Saline-filled Breast Implant, Mentor will replace the product, free of charge, for the lifetime of the patient. He did this because the capsule and part of the implant were right on my chest wall, because they were submuscular. A sponsors failure to comply with any post-approval requirement may be grounds for withdrawing approval. FDA. One weekend in early 2014, i took a severe turn for the worse. Memory problems, disturbing enough to affect me emotionally as well. It was reported that (b)(6) the female patient underwent primary breast augmentation surgery using mentor gel implants in 2000. Mastectomy reconstruction revision for deformed reconstructed left breast. I thank the rheumatologist for validating the fact that the implant could be the cause. At least make every day doctors like rheumatologists aware that this is happening, and what can happen if they dont treat it right away. Five years of medicating my body when it was trying to say please get these out of me. * In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients. Link. Weight began to plummet, as did blood pressure and just all over general malaise. 1* Choose from a wide range of sizes and profiles including Moderate Classic, Moderate Plus, High, and Ultra High. Link. Mentor MemoryGel (Premarket application number: P030053) (Approved November 2006) Description and Detailed Information Links: Mentor's MemoryGel Silicone-Filled Breast Implants have a. SALINE-FILLED MAMMARY PROSTHESES WITH DIAPHRAGM VALVE. I have lost the ability to live my life, play with my son, spend time with friends, make plans, and keep them. I would give anything to have my life back. I have been to the er several times because i was choking at that time i was using a solution to help clean out my sinuses, i dont realize it was causing me to feel like i was choking even more. This event was reported via # medwatch (mw5032276). Link. Therefore, in addition to documenting the product description and purchasing information, you should also carefully organize all of the necessary steps required to take advantage of any recall compensations. 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. Yet, when i seek the care of specialists, few are able to set a solid diagnosis and i also received clashing diagnosis when seeking second opinions. Within a year of receiving mentor silicone high profile breast implants my health had declined tremendously. UkEq5LuEBf&ei'FKNl, @HfoB}S#L +nj^yJnJ(k7D?$$$# 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. I feel my breasts are ruined forever now. The packaging appeared to have pinholes or bites, as well as black dots that could have been bug droppings. Link. 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# Patient also had developed rashes and pruritis. I could not get a deep breath. I have mentor cohesive gel breast implants and experienced symptoms almost immediately. 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. 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