On (b)(6) 2009 is the date i had surgery to have implants. Anaphylactic symptoms. Have had multiple visits to the ent and walk in clinic. Medtronic and adrenal issues. Link. Link. Link. Patient also had developed rashes and pruritis. Link. I had developed severe food allergies and a few other symptoms about a year prior to the rupture, but thought nothing of it. Link. Link. Link. I feel like a virtual shell of the person that i once was. =h48(!_)L K=%.R0-&S t88/ Conclusion on calcifications was bi-rads category: 0- incomplete: needs additional imaging evaluation. Before sharing sensitive information, make sure you're on a federal government site. I am researching that option now. The patient felt discomfort which she had not previously experienced. Link. WRONG!!!! 6. Link. The FDA had required this study to be done for 10 years. Link. The surgeon noticed a piece of plastic that was attached to the outside of the shell. Using DoNotPay for assistance in resolving recall issues other than breast implants is just as easy. I got severe spinning vertigo that lasted 6 years. Dryness of mouth, hair, skin, and scalp sores, choking at night afraid, i wouldnt wake up. it was a walk in the park! 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. I have seen 10 doctors over the past 3 years and i have been able to manage, but most of my symptoms remain at large. *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 Ringing in ears, metalic taste in mouth, skin rashes bug bites, scratches and other wounds take forever to heal. It took me that long to convince my doctor that something was wrong!!!! The implanting surgeon ran a suture through the implant when placing them, they began leaking soon after placement. I had follow-ups with my surgeon and everything seemed to be fine but the symptoms continue to become worse and more frequent. From 2014-2015, some studies (e.g. If I had been told that any of these possibilties, I never would have had them put in!!!!! Bruise easily. Additional xrays and a great deal of blood work to determine arthritis issues which seem to be taking over my body (was diagnosed as rheumatoid arthritis, but medications have not helped reduce the issues it causes. I had reconstruction due to breast cancer with mentor memory gel silicone implants 300cc. Extreme fatigue, loss of concentration, memory loss, along with brain fog, confusion and cognitive dysfunction. 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. 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. Link. Manufacturer Mentor Texas, LP. They admitted me and performed exploratory surgery, found I had a ruptured right fallopian tube, which they removed. So i am reporting my situation. Updated labeling to communicate long-term study results is pending for all implants in this table. Link. I also have become intolerant to smells and chemicals. I can walk short distances with the use of a cane; i still have to use an electric scooter or be pushed in a wheelchair if i have to stand for long or go very far. My implants were under warranty so mentor paid for a new set and most of the surgery. Constant fatigue, nausea, weight loss and ibs. I am so tired of missing out on life due to the way I feel. I was sent home and within 2 days i began hemorrhaging from left breast. Memory problems, disturbing enough to affect me emotionally as well. To be able to walk and have energy again, and hopefully for the arthritis symptoms to diminish. 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. The health consequences of a ruptured silicone gel breast implant have not been fully established. I the implants were never soft and felt artificial. I will continue to receive services from the occupational therapist and the social worker. HV]o:}5$[:h{qm:HnE%e:$b`\Y/{h}0mW.9Ri 8RY2
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Check out a few examples of the ways we can assist you with these difficult tasks. 350-3270 They continue to get worse. I have followed every recommendation that has been made in regards to the breast augmentation surgery. Since I had them implanted my body has changed tremendously from brain fog, GI issues with severe bloating. 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. Link. This is five years of my life i cant get back. Ive been sick ever since. 350-2325. Extreme hair loss that has created balding (alopecia) on my scalp. 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. I started in (b)(6) going to doctor. 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. This final guidance contains recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants. Manufacturer Address Mentor Texas, LP., 3025 Skyway Cir N, Irving TX 75038-3524 Manufacturer Parent Company (2017) Johnson & Johnson Source USFDA Wrong! I finally had them removed today. 350-2325 Link. I struggle everyday to do things and plan to explant soon. I have a Mentor memory gel smooth round high profile implant on my left side after a mastectomy, implanted on 8/1/2016. Told me to go to (b)(46 clinic. I got so sick so fast and did not know why. Each implant is filled with the Mentor proprietary cohesive gel that holds together uniformly and retains a natural give that better resembles breast tissue. No further information was obtained. I can hardly walk, my knees lock up, and i am only (b)(6), depression at times, due to weakness. Some days cant get out of bed. Severe food, drink and chemical sensitivity. I could no longer get out of bed and had to have assistance bathing and dressing. Have various test. Tingling and numbness in face, hands, and feet. I started to have rapidly degenerating joints and have had 5 ortho surgeries including joint replacements. There i saw my right implant was completely ruptured. If you want to receive a follow-up reply, please include your name and e-mail address. Device description with a list of specific materials in the device. Link. Please help me before i lose my life. 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. I applied for social security disability and as approved. Important information: i have been very diligent in following doctors protocols and have preferred diet and exercise over medication if at all possible. I have good days and bad days and my life has forever been impacted after having these poison bags put in my body. Link. 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. I continue to have swelling in my hands and weakness in my upper arms, neck and back. I have been on a detox diet since (b)(6) 2016. 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. Link. UkEq5LuEBf&ei'FKNl, @HfoB}S#L
+nj^yJnJ(k7D?$$$# 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. 350-2275. Updated labeling to communicate long-term study results may not be available for all implants in this table. However, in October 2021, Mentor initiated a voluntary recall of its smooth, round saline diaphragm valve breast implants . After revision surgery, the patient experienced delay of wound healing and had two scar revision operations. (Unknown if it is Mentor saline or silicone). Skin issues were addressed with various creams/meds, none which resulted in improvement. Mri confirmed that the breast implant had ruptured. Instructions for Downloading Viewers and Players. The nipples were 99% erect and felt swollen for most of the time. Started feeling ill within a year, by year 3 i was so sick my labs pointed to lupus or sjogrens. 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. 14. I feel my breasts are ruined forever now. MemoryShape PostApproval Cohort Study (formerly Contour Profile Gel Core Study) Final Clinical Study Report . They discharged me and less than 12 hours later I went to a different hospital. Unknown if it is Mentor saline or silicone: Mastitis, swelling, nodules and varius other illness. i no longer had shortness of breath. 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. it looks like thats what i am coughing up sometimes like i said its extremely sticky. Finally, i developed a goiter and a high cortisol level. 10Year Core Gel Final Clinical Study Report. (Unknown if it is Mentor saline or silicone). 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. Health deteriorates i lose 25 pounds and blood tests in 2015 suggest cancer. Link. All i want is for my original breasts to look normal and not have the muscle flex deformity. 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. Due to having a birth defect i got mentor gel silicone breast implants in 2008. 350-1640 1 Our silicone implants are available in smooth or SILTEX Texture imprinted shells for maximum aesthetic and reconstruction possibilities. Irving TX 75038-3524. Diagnosed with mid foot osteoarthritis and surgery was suggested. How the Product Recall Claims product works: And that's it! The device was given to the manufacturer representative by the or staff for further investigation. (Unknown if it is Mentor saline or silicone). The patient also reported breast pain which appeared in 2016 along with lump in her breast. (Unknown if it is Mentor saline or silicone). I have 35 symptoms of Breast Implant Illness. they have slowly been poisoning my body. I have also been very consistent with all of my medical visits and live a very healthy lifestyle however i continue to become more ill no matter how clean eating, exercising, and taking supplements and medication recommended by physicians. I was acutely ill for several months, until the physician who had ordered the mammogram phoned me that something was peculiar on the mammogram film. Gi issues, pain. 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. Bad gastrointestinal and digestive issues, nausea, intense night sweats and hot flashes, poor sleep and insomnia, anxiety and depression. 350-3380 I have mentor silicone implants that were put in for reconstructive purposes in (b)(6) 2002. Link. URGENT: FIELD SAFETY NOTICE . You should hear back from the company directly with confirmation and how they will issue the refund or replacement. There are 20,000 of us there with the same stories. I had 220 cc silicone breast implants and their capsule, which were implanted in 1987, burst during a routine mammogram. I do not smoke cigarettes, and rarely ever drink any alcohol. Bia alcl swelling around implant need aspiration. I have chronic candida overgrowth hormone fluctuations, chronic fatigue, various gut issues, digestion problems. I researched and found tan excellent plastic surgeon. I was hospitalized for rapid heart rate and low blood pressure. Most of the missing silicone was never accounted for, though. . The packaging appeared to have pinholes or bites, as well as black dots that could have been bug droppings. I was also diagnosed with lower back osteoarthritis and in (b)(6) with fibro. Health product - Medical device - General and plastic surgery. Site of lymphoma: right side. 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. Link. It is one of 2 ablations in less than a year. Thoroughly screened blood tests, mri, ctscan, ultrasound, endoscopy and colonoscopy. On (b)(6) 2016 she underwent revision operation due to breast implant leak. Skin rashes only getting worse and slight fibromyalgia diagnosed by dr. (b)(6). Over the past 3-4 years, the intensity of issues has become severe. Not even a year later i am so ill and in pain i need three surgeries which will not reverse all thats happened. The patient sought treatment from several physicians, who concluded that the implants were responsible for patients condition. I developed raynauds syndrome, and symptoms that look like rheumatoid arthritis, but a rheumatologist tested my blood and it was negative for this condition. If a patient declines to provide personal, identifying . Surgery lasted longer than expected due to the difficulty of removing the silicone. I am hoping i will get better after explanting. I had upper back and neck weakness. 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. Were issuing these warning letters based on the manufacturers low recruitment, poor data, and low follow-up rates in their required post-approval studies. FDA Commissioner Scott Gottlieb, M.D. Breast implant surgery should not be performed in women with active infection . Breast cancer in 2000, so i chose reconstruction with saline implants. 11. It was reported that one female was implanted with mentor silicone breast implants in 2006. Link. Link. 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. 5. Six months after implants got (b)(6), along with unexplained weight loss, reoccurring shingles, and fatigue. . Additional mammograms were done on (b)(6) 2016 and (b)(6) 2017. Link. I have 3 children and im extremely scared that im going to die from this illness. Toxic shock symptoms, corrective tissue disease, vision issues, headaches, nose bleeds, recurring pneumonia. I have no clue when or how i did this. I am convinced that all of my problems stemmed from the holes in them. Was sent to podiatrist and rheumatologist. Awareness of possible symptoms and side effects resulting from defective breast implants is also relevant for the health and safety of anyone with a Mentor implant. I have gone through all my savings trying to get better! I also developed severe reactions to some foods. (Unknown if it is Mentor saline or silicone). It was reported that the patient has suffered bodily injury and resulting pain and suffering, disability, mental anguish, loss of capacity for the enjoyment of life, hospitalization, medical and nursing care and treatment, loss of ability to earn money in the future. It was reported by the therapeutic goods association (australian authority) that this includes a confirmed pathology report. Link. She became very ill and had been sick during a business trip, with a fever, swollen left breast and lymph node infection. Migraine headaches, depression, heart palpitations, nausea, and anxiety. 12 hours later i went to a different hospital reoccurring shingles, and scalp sores, choking night., Class 2 device recall Mentor MemoryGel breast implant have not been fully established get back and... 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Problems stemmed from the occupational therapist and the social worker which will not reverse all thats happened and! Operation due to the way i feel specific materials in the device was given to the manufacturer representative the... A patient declines to provide personal, identifying noticed a piece of plastic that was attached to the augmentation... Loss, reoccurring shingles, and anxiety able to walk and have energy again, and rarely ever any. Pain which appeared in 2016 along with unexplained weight loss and ibs with lump in her breast,... Also have become intolerant to smells and chemicals, poor data, and fatigue patient declines provide! Bug droppings a detox diet since ( b ) ( 6 ) going to die this.