Extreme chronic fatigue, atypical connective tissue disease, breathing problems laying down. 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). Many test to follow. I started to have rapidly degenerating joints and have had 5 ortho surgeries including joint replacements. Link. Link. Blurry vision, memory fog, fatigue, numbness in hand and feet, joint pain, urine retention, trouble concentrating, weight gain, ringing in my ears, anxiety, skin rashes, sleep problems, fungus on my rt toe that will not go away and i keep loosing my toe nail. Link. No deflation were found on both devices. H\j@}l/ `t I had silicone breast implant and for years had every test there is to find out what was wrong with me. . The alarming conflict of interest in the manufacturers sponsoring the studies and in the plastic surgeons handling the study is astounding. Link. In doing my research, i trusted the fdas recommendation that these were very safe implants. I obtained a family doctor at this point who subscribed thyroid meds and followed me with maintaining therapeutic tsh levels. Severe food, drink and chemical sensitivity. Each implant is filled with Mentor's cohesive gel, which holds together uniformly and retains a natural give that better resembles breast tissue. Silicone implants causing symptoms such as weakness, as if something is sucking the life out of me, low thyroid, low wbc count, intense joint and muscle pain. I have chronic widespread pain and digestive trouble. Currently, diagnosed systemic lupus. The swelling comes and goes. Over time since implants. I have heart issues, fatigue, high metal to city that can lead to significant cardiac issues. I have had numerous health issues over the years since the implants but this winter, things got worse. Device Tracking Form supplied by Mentor with each silicone gel-filled breast implant. Device Failure Study: The summary of findings did not list: sample size, results of the data findings (no clinical data and no visual inspection data), safety findings, recomendations, summary of safety and data, and nor did it list any changes to labeling. Link. 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. It was reported by the therapeutic goods association (australian authority) that this includes a confirmed pathology report. 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. MemoryGel Breast Implants (Mentor Worldwide LLC, Irvine, Calif.), approved by the U.S. Food and Drug Administration in 2006 for breast augmentation in women aged 22 years and older and for breast reconstruction in women of any age, consist of a single-lumen, round silicone elastomer shell, with a patch on the posterior side, and filled with a cohesive silicone gel. I went to the er, where they werent sure what was wrong and gave me antibiotics, which had no effect. 6. MemoryGel Breast Implants provide a soft, natural feel desired by patients. (D4T(']RNk7J I can hardly walk, my knees lock up, and i am only (b)(6), depression at times, due to weakness. I have good days and bad days and my life has forever been impacted after having these poison bags put in my body. Link. Link. Panic attacks, chest pain, breast pain, inflammation, depression. Cause 2. Have mentor breast implants. Link. It was reported via an fda medwatch form (#mw5072162) that a patient who underwent breast prosthesis implantation with a mentor textured gel device on (b)(6) 2015 was diagnosed with bia-alcl. So, i began my research for answers. im so frustrated and depressed about the last 12 years of feeling horrible and i wish i never decided to get new implants. No doctor can help me and i fully believe its the breast implants making me ill. The implants were silicone made by mentor 600cc. Here are some examples of our many recall request assistance programs. One weekend in early 2014, i took a severe turn for the worse. 12. 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. I the implants were never soft and felt artificial. I have state insurance as of 2012 after being too ill to work full time and my dr does not accept this insurance. Manufacturer Reason. I was diagnosed with hashimotos thyroiditis 3 years ago. 7. Sudden food intolerance to gluten, shortness of breath, liver dysfunction and cramping. For Additional Information Contact. But since the surgery i feel like my lymph nodes are constantly swollen and keep struggling to fight off infections and colds. Five years of being sick. 350-2200. 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. In (b)(6) of 2016 the implants were explanted and reported to be filled with mold. Link. 350-2250 These were requirements of the Approval Order. 5 years, she began to suffer from serious health issues, including but not limited to, constant headaches, difficulty with concentration and focusing, constant pain and swelling in left breast, high anxiety, shoulder and neck pain, obsessive compulsive disorder, muscle weakness, symptoms that resembled fibromyalgia, insomnia, memory issues and other symptoms resembling chronic fatigue syndrome. Manufacturer Address Mentor Texas, LP., 3025 Skyway Cir N, Irving TX 75038-3524 Manufacturer Parent Company (2017) Johnson & Johnson Source USFDA 350-2300 I suffered from extreme fatigue, and my joints were swollen, especially my right knee. I could no longer get out of bed and had to have assistance bathing and dressing. The site is secure. She had hashimotos disease, chronic fatigue, brain fog, possible alcl according to the physician. Muffled ears like swimmers ear. As of(b)(6) i no longer was able to work. It was reported that (b)(6) the female patient underwent primary breast augmentation surgery using mentor gel implants in 2000. 350-2250. 10. Ive been sick ever since. I had 220 cc silicone breast implants and their capsule, which were implanted in 1987, burst during a routine mammogram. Within 6 months of that time frame, i started to have medical concerns, which were unusual for me. 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. 2 I have a lot of health issues because of them. CUwQp.u/p1{Zhi _Sx*51m]`12N}|4}5tR|-\N78G dTYvkr1f|^ok+ s!Q?mNmv4 5YxQbWTw q]fwSb#S~/D:tDJP2FP1U$oM"~\.gB\UU)m+U'zd}D1 X:-BqeI6 \y +@i @PZ/iT>e Tcc13 >VC^% This is five years of my life i cant get back. It has been a year of feeling acutely ill. Then in 2011, i was diagnosed with a rare blood cancer. Alcl stage and alcl treatment are unknown. Besides developing multiple food sensitivities, i have also developed an extreme sensitivity to mold and chemical exposure. Cant handle the sun anymore, can no longer jog/run. (Unknown if it is Mentor saline or silicone). After several years of pain and discomfort and being diagnosed with sjogrens syndrome, lupus, arthritis, fibromyalgia, high blood pressure, my plastic surgeon recommends the removal of my implants. Some respondents suggestedthat the true purpose of the brochure was to protect Mentor, rather than inform patients about breast implant surgery. I went from saline smooth implants to textured cohesive gel implants. Experiencing joint pain, chronic fatigue, brain fog, swollen lymph nodes after mammogram. I feel like a virtual shell of the person that i once was. dizziness (light headedness). Smooth surfaced implants are not affected by this recall. I was given iv cipro for several days. Post-approval studies (PAS) are conditions of device approval. I had silicone breast implants from mentor in 2013. 350-3250 MENTOR Breast Tissue Expanders. Tingling and numbness in face, hands, and feet. 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. I have had nothing but health problems since I got these in plants put in. I had mentor cohesive gel implants placed. Updated labeling to communicate long-term study results may not be available for all implants in this table. 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. *sOiB'|lC756s7{B6/L5!Szi}VU&K/cUm.zwkeriZH>yOmw6]x2MP7>j|hg@ln5xCi`UD}9' .eEeEeEdfz{=xE^ll`[;;;:888:888:888:888!KbaA0 ,03 However i had in 2010 began to be diagnosed with many more autoimmune disorders. This is the date of my first cardiac ablation for persistent premature ventricular contractions (pvc). The FDA's warning letter to Mentor Worldwide LLC (Mentor) noted several serious deficiencies in the manufacturer's post-approval study for its MemoryShape breast implant, first approved in. I have mentor silicone implants that were put in for reconstructive purposes in (b)(6) 2002. it was a walk in the park! No further information was obtained. Tell us about your purchase, including the product name, brand, store you purchased the item from, price, and date of purchase. Avoid delays that will only cause undue stress, worry, or possibly affect your health by using DoNotPay. Mentor MemoryGel (Premarket application number: P030053) (Approved November 2006) Description and Detailed Information Links: Mentor's MemoryGel Silicone-Filled Breast Implants have a. Bia alcl swelling around implant need aspiration. Have various test. DoNotPay will send your implant recall request to the manufacturing company on your behalf, asking for a refund or replacement. Anaphylactic symptoms. Link. My medical bills from this are near (b)(6) and its just not right. 350-2325 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). !C`2D0NzI%jFCBZZ#XJA|r Y^kb?3q4 Her email is [emailprotected] and phone number is (301) 796-6134. Previous to implants i was on medication for thyroid issues, but nothing else and was in very good health. Five years of medicating my body when it was trying to say please get these out of me. After 2nd scar revision surgery, breast tissue was sent for pathology and she was diagnosed with implant-related anaplastic large cell lymphoma on (b)(6) 2017. I had developed severe food allergies and a few other symptoms about a year prior to the rupture, but thought nothing of it. I couldnt think clearly, and i could not sleep. Health deteriorates i lose 25 pounds and blood tests in 2015 suggest cancer. 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. 5. Did not make the connection until years of doctors visits and laboratory test came back negative except for autoimmune disease. Contact the manufacturer if you require additional information. I feel my breasts are ruined forever now. However, there was nothing changed in my lifestyle or diet to being on any of these changes. Instructions for Downloading Viewers and Players, Class 2 Device Recall Mentor MemoryGel Breast Implant. 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. 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. The fda say they are safe. More than 10 numbers, contact manufacturer. 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 . It is also possible that you will not recoup the associated costs until after you have paid for the procedures and check-ups in advance. On the date listed above, i received breast augmentation with mentor smooth round high profile gel (silicone) implanted ref (b)(4), left lot #6528127, sn # (b)(4) and right lot #5950089, sn # (b)(4). I was unable to leave my house unaided from (b)(6) due to this illness. It was reported by a customer that a shipment of mentor memory gel breast implants was received with damaged packaging, bugs inside the shipping box and black underneath the seal. Since explanting, i already am noticing symptoms subsiding such as my brain fog, temperature regulation and ability to focus clearly. Mentor silicone implants caused a slew of health issues. Lived with 20+ symptoms for over 5 years. 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. Extreme swelling throughout my body had to use a lymphatic drainage machine 2xs per day for 75 minutes. 1* Choose from a wide range of sizes and profiles including Moderate Classic, Moderate Plus, High, and Ultra High. When recalls are as vital as a Mentor breast implant serial number recall, you should never ignore them. Through our Product Recalls, all you have to do is tell us about the product you purchased and provide receipts/other evidence, and we'll contact the company on your behalf. DoNotPay can assist you with a simple, easy-to-use process in one place. I am researching that option now. Thoroughly screened blood tests, mri, ctscan, ultrasound, endoscopy and colonoscopy. If a patient declines to provide personal, identifying . I felt like i was dying. Site of lymphoma: right side. I fortunately found a (b)(6) support group for women with breast implant illness, what i believed to have. Finally, the FDA released updated information on the status of breast implant manufacturer post-approval studies. Dizziness muscle cramping, bone pain, myofascial pain, gastrointestinal/abdominal pain, inability to exercise despite being a lifelong competitive athlete. Rheumatologist said i am at high risk for lymphoma. 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 blood tests urine testing, ct scans, mris, and neurological testing. The health consequences of a ruptured silicone gel breast implant have not been fully established. Sudden decline in health and increase in pain of area of implants as well as systemically. No reports of rupture or other product issues. 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. 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 actually held the implant and was assured the silicone would not leak out and if implant were punctured, the silicone would remain inside implant. Link. Mentor stands by its textured implants and says the cancer is "rare" with its product. Link. I would give anything to have my life back. Brain fog, memory loss, muscle pain, weakness, joint pain, dizziness. 'D))2eYhkE1yj{Y0\. Rushed to surgery for third time. I had the implants removed at the end of 2015. Neck, shoulder pain along with tension on where my head and spine meet. I have been on a detox diet since (b)(6) 2016. This is not a one time event, but this was the beginning of many different health issues i had. Informed Decision Study: Overall, this study seemed self-serving to the physicians who are ironically the ones conducting the study on their patients. They were smooth, round, and saline, 270 on one side and 300 on the other. Had many blood test and i have all of the results. The .gov means its official.Federal government websites often end in .gov or .mil. 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. Important information: i have been very diligent in following doctors protocols and have preferred diet and exercise over medication if at all possible. These issues impact daily. MENTOR MemoryGel Breast Implants and MENTOR MemoryGel Xtra Breast Implants are round devices with shells constructed from medical grade silicone elastomer. Only need to get an mri if you suspect a rupture or feel contracture. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. I have hot and cold sensitivities. In fact, since implantation i do not have a taste of alcohol and have become sick whenever i have tried to drink even in moderation. Metalic taste in my mouth. I have had 5 surgeries for shoulders and 2 on my hands. Link. However, i am left with a chronic illness now that most likely will need some medication, supplement, and labs and doctor visits to manage for the rest of my life. I began having rheumatoid symptoms inflammation, huge knots popping up in various joints, pain on level 10. Breast implant manufacturers may need to update product labeling as the FDA learns new clinical information. 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. No contact information was provided in mw report, therefore no further information has been made available. 9\?~=4fY[[x|2=(;/QVUTr4( Please help me before i lose my life. Link. The following section provides links to the approved labeling and the progress of expected labeling supplements. Patient had implants explanted on (b)(6) 2016. There is original labeling (at the time the FDA approved the implant) and current labeling that is updated with post approval study information and to adequately communicate the risks. Unexplained rashes, difficulty walking and breathing, pain in my joints, couldnt touch my body. I grew increasingly weaker and more ill. I could not get a deep breath. Patient also had developed rashes and pruritis. Link. 304 0 obj <> endobj I have breast implants and they are causing chronic inflammation in my body leading to various health conditions even to hospitalization. Upon further inspection of the inner shell, the surgeon noticed black specs floating in the fluid. Now all i want is my life back. 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. The pharmaceutical company Allergan has recalled all BioCell textured breast implants at the request of the US Food and Drug Administration (FDA) because they have been linked to a rare type of lymphoma: breast implant associated anaplastic large cell lymphoma (BIA-ALCL). Shoulder and neck pain, pain under my rt rib. Consumers are regularly alerted to product recalls thanks in part to the Consumer Product Safety Act. I explanted 3 weeks ago and all my pain is gone. Using DoNotPay for assistance in resolving recall issues other than breast implants is just as easy. Mentor is commited to product safety. Esophagus is where it is stuck, it takes hours to get these disgusting chunks out of my throat and its exhausting. Over the next 3 years my health steadily declined with unexplained symptoms. Multiple attempts have been made to obtain more event details, however, no additional information has been made available. This is socially unacceptable because i have to cough and spit all the time trying to get this extremely sticky substance out of my throat. I started to feel better after that surgery. 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. I want them out but cant get them out because I do not have health insurance. I am being treated for this currently. 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. Loss of interest and pleasure in doing activities. 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 am cold all the time and my hormones are poorly balanced on their own. Apparently mentor did not get the message about a ban on implants. Both of the implants had holes. Auto immune disease, hands were swollen, red, and itchy. Link. Mentor strongly recommends that all patients receiving silicone gel-filled . Mentor implant recalls, unlike other recalls, may require multiple doctor's visits and even surgery. I had a breast augmentation on (b)(6) 2015. There i saw my right implant was completely ruptured. Note: If you need help accessing information in different file formats, see Since then i had a lot of health issues, most of them have been of autoimmune reactions involving: vascular system, neurological (brain fog, numbness in limbs), asthma, heart palpitations, extreme fatigue, hormonal issues, sensitivity to chemicals, allergies. for Recall. Her face started to swell when she got cold. Painful joints (most hands, knees, hips, shoulders) bone pain swelling of hands, tight skin. It took me that long to convince my doctor that something was wrong!!!! Breast implant surgery should not be performed in women with active infection . 350-1610 She was scheduled to remove implants the following month. 350-3230 Link. Due to length of initial surgery as well as length of hospitalization, i chose to wait. endstream endobj 308 0 obj <>stream 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 would not recommend implants to anyone. It was reported that a (b)(6) year-old female underwent primary augmentation surgery using mentor silicone implants. I have followed every recommendation that has been made in regards to the breast augmentation surgery. 350-2275. Unknown if it is Mentor saline or silicone: Mastitis, swelling, nodules and varius other illness. 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. Diligent in following doctors protocols and have preferred diet and exercise over medication if at all possible contracture. 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