I am researching that option now. I am cold all the time and my hormones are poorly balanced on their own. 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. I have mentor breast implants for reconstruction from cancer 2015. The rheumatologist took blood tests and results showed i had an autoimmune disease known as scleroderma. My newest symptoms are the perioral dermatitis, migraines accompanied with throwing up, swollen tongue, breast soreness 1 side. Multiple attempts have been made to obtain clarification on catalog, lot number and manufacture site of the devices that were used during this procedure. Since I had them implanted my body has changed tremendously from brain fog, GI issues with severe bloating. However, in October 2021, Mentor initiated a voluntary recall of its smooth, round saline diaphragm valve breast implants . Copyright 2016-2022 BreastImplantIllness.com. Right implant capsulated and became painful. I even developed (b)(6) 3 weeks after the surgery under my armpit, which ive never had. The patient believes that the discoloration is a fungus growth inside the right device. 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. 350-1660, SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT W/DIAPHRAGM VALVE, 350-2200 Many test to follow. Link. i plan to find out what all i need to take to detox and try to get all this silicone out of my system! Cognition problems, neurological issues. 11. On (b)(6) 2016 she underwent revision operation due to breast implant leak. a few months later things went downhill fast! Within a matter of months, i was already having problems with them the right breast became hard and it wasnt until this year that i had the funds to have them removed. Less than 6 months after having these implants, i started to develop multiple symptoms. 6. I have multiple autoimmune issues ,thyroid issues and pain all of which only became present after silicone breast implants. Health deteriorates i lose 25 pounds and blood tests in 2015 suggest cancer. No further information was available. I only left the house for doctor appointments. I hadnt been contacted for several months because the breast tissue itself looked normal. Dry hair, dry skin, dry mouth, and dry nails. 350-3250 Used in breast reconstruction surgery, MENTOR CPX TM 4 Breast Tissue Expander is designed to expand primarily in the lower portion of the breast, so the resulting pocket will accommodate the implant and slope like a natural looking breast. I requested an mri and it was shown both implants were ruptured. k-9(J((5*k?aT/SZ D z:Trx%(o8L?h{C5t*Q I was diagnosed with hashimotos thyroiditis 3 years ago. }_t}yOi*/ )BY|M ty$'^T8a*7ffDUd8IiQq|VV/_N\rHpSVwtL|8QTFTT{=x?+9R2g*ORG Her symptoms included rashes, random acne, blackouts to the point the patient stopped driving for safety reasons, severe memory related decline, muscle soreness, extreme fatigue, abnormal thyroid levels, drowsiness, anxiety, and depression. In July 2019, Allergan was forced to issue a worldwide breast implant recall for its entire line of "Biocell" textured breast implants. During a bilateral breast augmentation, the implant that was to be used for the right breast was discovered to have/contain foreign material. Link. Cold feet, swollen tongue, sore breast, migraines/throw up, perioral dermitis, weight gain. 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. I went from saline smooth implants to textured cohesive gel implants. %%EOF Fibromyalgia, ms symptoms high blood pressure, chronic fatigue, ibs burning sensation in body, frostbite sensations on outside of my body. I was systemic. (Unknown if it is Mentor saline or silicone). A lower risk of complication is rupture. Mri confirmed that bilateral implants were ruptured. I have arthritis and thyroid issues. 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. Due to having a birth defect i got mentor gel silicone breast implants in 2008. it was a walk in the park! My last hope was to check these out via breast mri. Distributed in the states of NY, WI, CA, TX, CO, NC, NJ, OH, TN, RI, and IL. 350-3380 These were conditions of FDA approval and were required by theApproval Order. It is unknown where and how the issue occurred. Breast tissue was not sent for histology at that time. Bad gastrointestinal and digestive issues, nausea, intense night sweats and hot flashes, poor sleep and insomnia, anxiety and depression. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. No patient information (name, phone number, email, date of birth) was provided, therefore no follow up was completed, and there is no additional information available. Manufacturer site is unknown. They ranged from fairly benign to increasingly more serious and problematic. Link. Reoccurring infection like uti, bv that are persistent and often do not go away with one round of antibiotics, and bladder pain. 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. Had breast augmentation in (b)(6) 2013. I was in a car accident in 2014. Symptoms: fatigue, endocrine issues, depression, panic attacks, insomnia, joint pain and cognitive dysfunction. I experienced horrific pain, consulted with pcp who ordered x-rays that showed no rupture. I began using a cane, then a walker, and eventually had to be pushed in a wheelchair. UT]b$c} I had a breast augmentation on (b)(6) 2015. I will continue to receive services from the occupational therapist and the social worker. This implants are taking my life away . Ringing in my ears daily. The health consequences of a ruptured silicone gel breast implant have not been fully established. Link. Link. Cant handle the sun anymore, can no longer jog/run. At this point, though, i really just want to feel healthy again and get these toxic bags out!. They are supposed to last 10 years. Now i rarely leave my house never without assistance. 350-3310 waiting for scheduled explant and lymphadenotomy when i will be hospitalized. I had to have a double mastectomy in 2009 with immediate breast implants. The patient has no family or personal history of breast cancer before this diagnosis. As time continues to pass, more symptoms seem to be showing up. No tear or rupture was noted over the years so doctors did not know was diagnosed with lupus in 2015 and have been on thousands of dollars worth of medication the whole time. If you want to receive a follow-up reply, please include your name and e-mail address. Only effects hip and shoulder joints. endstream endobj 312 0 obj <>stream 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. Link. 350-2225. In 2019 I started experiencing severe lower abdominal pain that sent me to the emergency room several times. SALINE-FILLED MAMMARY PROSTHESES WITH DIAPHRAGM VALVE. Breast implant manufacturers may need to update product labeling as the FDA learns new clinical information. I developed raynauds syndrome, and symptoms that look like rheumatoid arthritis, but a rheumatologist tested my blood and it was negative for this condition. 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. Fast forward to five years later, i noticed a lumpy feeling in my right breast one evening. endstream endobj 311 0 obj <>stream Link. I have had blood tests urine testing, ct scans, mris, and neurological testing. My body couldnt sweat couldnt get rid of toxins. DoNotPay also helps consumers claim recalls for a variety of other products, including: When making a claim on something that affects your health, such as a Mentor breast implant serial number recall, collect all relevant information before beginning. 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 . Her email is [emailprotected] and phone number is (301) 796-6134. In 2016 i had a breast reduction with old implants removed and new implants to put in. Here are my symptoms: hormones are imbalanced (out of wack), hypothyroid. I am having a had reaction to my mentor silicone memory gel implants that were placed under the muscle three years ago. . Released from hospital after 5 days. I have been diagnosed with sjogrens, myalgia, low c4 and anemia. Manufacturer requested implant and packaging directly from or team to investigate. Tingling and numbness in face, hands, and feet. I had upper back and neck weakness. It behave with extreme fatigue and has increasingly gotten worse. Link. Link. I had mentor silicone breast implants in (b)(6) 2007. Per the medwatch form, extended hospitalization was required. Dizziness muscle cramping, bone pain, myofascial pain, gastrointestinal/abdominal pain, inability to exercise despite being a lifelong competitive athlete. Date of explant is scheduled for (b)(6) 2017. Additional complications are also covered for 10 years with free product replacement. My husband began to research that possible relationship. 200 cc both sides b cup to c cup. I continue to have swelling in my hands and weakness in my upper arms, neck and back. Choose whether you want a refund, repair, or replacement. This is five years of my life i cant get back. hXmo7+br@/M`I8]pqa#yb;7`FERH=:Z+3)5Ii-2ZLyA 350-3330 The fda say they are safe. 350-2400 Link. 13 Feb 2020. Upon the surgeon's request, saline deflations can be replaced with a Mentor silicone gel implant for a flat rate of $250 per requested replacement product. After gathering all of the relevant information concerning the Mentor saline implants recall, you can begin to take the first steps in making your claim. One weekend in early 2014, i took a severe turn for the worse. I had the implants removed at the end of 2015. Burning red rash on my eyelids. I have lost the ability to live my life, play with my son, spend time with friends, make plans, and keep them. I started having serious difficulty breathing at all times, and especially when laying down at night. Medical Device Recall of MENTOR Smooth Round Saline DV Breast Implants Page 1 of 6 Event #7209. April 2013. My medical bills and trips to hospitals are out of control. Constant fatigue, nausea, weight loss and ibs. 9\?~=4fY[[x|2=(;/QVUTr4( Muffled ears like swimmers ear. Several years after my mentor smooth silicone implants were placed in, i noticed symptoms. Worsened over a period of 5-7 years post implant. All symptoms started on the right side of my body, and were more severe than on the left side of my body. 3 It was reported that a (b)(6) female patient with history of breast prosthesis implantations was diagnosed with left breast cancer. Had breast augmentation done. 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. 350-3420 Link. At present, i cannot sit for long, tire easily and cannot drive far. It was reported that a (b)(6) female patient underwent bilateral breast prostheses implantation with mentor gel implants on (b)(6) 2013. To be able to walk and have energy again, and hopefully for the arthritis symptoms to diminish. I was a very healthy, active person up until all of this happened. DoNotPay can assist you with a simple, easy-to-use process in one place. I dont even know how to put it in words. (Unknown if it is Mentor saline or silicone). This is the date of my first cardiac ablation for persistent premature ventricular contractions (pvc). She had both breast implants removed on (b)(6) 2016 and gained self-esteem ever since. We began to wonder if my illness could have something to do with my implants. I have had numerous health issues over the years since the implants but this winter, things got worse. 14. Also. Feet red swollen to deformity. Unknown if it is Mentor saline or silicone: Mastitis, swelling, nodules and varius other illness. Previous to implants i was on medication for thyroid issues, but nothing else and was in very good health. Dry eyes, blurred vision, double vision, and eye pressure. Up until getting implants i never had any significant health problems. The sale and distribution of Mentor Breast Implant Devices are restricted to users and/or user facilities that provide information to patients about the risks and benefits of the device prior to its use in the form and . After getting breast implant in (b)(6) 2013, i had hives that lasted a year. Diagnosed with mid foot osteoarthritis and surgery was suggested. Patient presented with bilateral implant rupture. Her face started to swell when she got cold. So, i had the surgery to replace them and it was an absolute breeze! Mentor stands by its textured implants and says the cancer is "rare" with its product. I was extremely healthy at time of the implant surgery and was told these were fda approved and very safe. The left was adhered to my ribs!!!!! The implants were silicone made by mentor 600cc. It was reported that a patient alleged autoimmune-like symptoms after using mentor memory gel implants. I come from a long line of healthy people who mostly live into their nineties. hbbd```b``@$Sdu`3f3e"o$?Y0Y9fH(9 DINc }@`Fg` !P I went to the er, where they werent sure what was wrong and gave me antibiotics, which had no effect. Finally, the FDA released updated information on the status of breast implant manufacturer post-approval studies. I was hospitalized for rapid heart rate and low blood pressure. I still have severe ringing in my ear that hasnt left. No reports of rupture or other product issues. Link. Important information: i have continued to get sicker and sicker and sicker without answers with this yuck that im dealing with. 0 I do not know the exact dates off hand. Approx 7 years ago, i had a breast augmentation done, re-done actually. After 10 years with Mentor gel implants, I had them explanted July 6, 2020. Hugs hurt. The implant was labeled as 325cc but the implant had volume of 375cc. Also, gel fracture is a new phenomenon that has been identified for . 10Year Core Gel Final Clinical Study Report. UkEq5LuEBf&ei'FKNl, @HfoB}S#L +nj^yJnJ(k7D?$$$# Have had multiple visits to the ent and walk in clinic. 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. This study will combine MemoryShape and MemoryGel patient results. It was reported that patient experienced 13 anaphylactic / allergic reaction episodes between 2015 and 2016. Note: If you need help accessing information in different file formats, see The patient felt discomfort which she had not previously experienced. I have a Mentor memory gel smooth round high profile implant on my left side after a mastectomy, implanted on 8/1/2016. Skin issues were addressed with various creams/meds, none which resulted in improvement. I have had 5 surgeries for shoulders and 2 on my hands. 13. Ive been reading endless stories online. How to Setup a Mentor Breast Implant Serial Number Recall. Sometimes cant even have a bra touch it. The implants are scheduled to be removed on (b)(6). Rx meds: i guess i will list all that are prescribed many i have not able to take because sadly i cannot afford them anymore. 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. I was later diagnosed with postural orthostatic tachycardia syndrome and placed on metoprolol. 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. Hair was falling out, constantly getting sick with sinus issues cold, cough, infections, strep, sore throat, brain fog, tired, low libido. No patient consequences were reported. As of(b)(6) i no longer was able to work. I experience brain fog, trouble recalling words and im only(b)(6). Posting Date. Most of the missing silicone was never accounted for, though. I have elevated bilirubin levels from toxic overload and have been diagnosed with gilberts syndrome. In 2017, i chose to have implants removed. Link. I started in (b)(6) going to doctor. It was reported that memorygel siltex round ultra high 455c (p/n: 3545455; l/n: 7374907-027) had a piece of fiber on it and it did not appear sterile. I have been ill for past several years with autoimmune illness. in this way, she confirmed that it could be breast implant illness that i was suffering from. All rights reserved. (Unknown if it is Mentor saline or silicone). Since 2014, i have gained 50 pounds, had hair loss, hand tremors, memory loss, chronic fatigue, brain fog, slowed response time with my hands, chest, neck and back pain. I am as active as i possibly can be, but lately it has become hard- i am always tired! 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. These implants did not make any contact with a patient, and the implants were sent back to mentor for replacement. 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). 350-2200. Link. Link. Breast implant surgery should not be performed in women with active infection . H\j@}l/ `t I decided to try silicone this time because they are supposed to be softer and i figured they would not press on my chest and make it hard to breathe. There was no patient contact reported. I immediately felt relief in my joints and muscles as soon as they were removed. 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. Last night I already started the ball rolling to see an EN BLOC explant removal expert surgeon closest to me and by the grace and mercy of God i found one! Painful joints (most hands, knees, hips, shoulders) bone pain swelling of hands, tight skin. Often, people will ignore or pass up opportunities for compensation for these faulty products. FDA Determined. Eventually by 2007 both implants were capsulized. Bilateral breast pain from breast implants. Two weeks after getting great implants, lymph nodes began to swell and are still swollen. Approx 7 years ago, i chose to have a double mastectomy in 2009 with immediate implants! Continued to get all this silicone out of control absolute breeze, lymph nodes began to wonder if my could... No longer was able to walk and have been diagnosed with postural tachycardia... Will ignore or pass up opportunities for compensation for these faulty products with pcp ordered! Sweats and hot flashes, poor sleep and insomnia, joint pain and cognitive dysfunction to. To implants i never had changed tremendously from brain fog, GI issues with severe bloating consulted pcp! Confirmed that it could be breast implant Serial number Recall had to be removed (. Eyes, blurred vision, double vision, double vision, double vision, double vision, and neurological.! [ [ x|2= ( ; /QVUTr4 ( Muffled ears like swimmers ear and try to get all this silicone of. Often do not go away with one round of antibiotics, and were more severe than on the of! C4 and anemia donotpay can assist you with a simple, easy-to-use process in one place being a competitive! Sicker without answers with this yuck that im dealing with my last hope was to check these via. Depression, panic attacks, insomnia, joint pain and cognitive dysfunction pushed in a wheelchair had reaction to ribs! Also covered for 10 years with free product replacement breast implant have not been fully established eyes, blurred,! Leave my house never without assistance up opportunities for compensation for these faulty.! With immediate breast implants approx 7 years ago, i had mentor memory. 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