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. Please help me before i lose my life. On (b)(6) 2009 is the date i had surgery to have implants. my first ones were removed via the area incision and now i have an incision in the inframammary location. 1 Our silicone implants are available in smooth or SILTEX Texture imprinted shells for maximum aesthetic and reconstruction possibilities. An e. N. T. Dr i went to questioned me about my implants and suggested, i think about having them removed. 9\?~=4fY[[x|2=(;/QVUTr4( He did this because the capsule and part of the implant were right on my chest wall, because they were submuscular. Tingling in hands and feet, temperatures problems, depression, confusion. Don't let time and effort get in the way of taking advantage of getting what you need or are owed. 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. SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT W/DIAPHRAGM VALVE. Link. 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. Finally, i developed a goiter and a high cortisol level. I have a Mentor memory gel smooth round high profile implant on my left side after a mastectomy, implanted on 8/1/2016. Neck, shoulder pain along with tension on where my head and spine meet. The mammogram film showed the bursting of the implant. April 2013. I had developed severe food allergies and a few other symptoms about a year prior to the rupture, but thought nothing of it. Breast tissue was not sent for histology at that time. This is not a one time event, but this was the beginning of many different health issues i had. The plastic surgeon performed what is called a dual-plane approach half under/half over the muscle to give a tear drop shape). I developed raynauds syndrome, and symptoms that look like rheumatoid arthritis, but a rheumatologist tested my blood and it was negative for this condition. Now all i want is my life back. The left was adhered to my ribs!!!!! My situation was as such: in (b)(6) 2015 after being diagnosed with ductal carcinoma in situ (dcis) for a third time in 12 years, i had a mastectomy with immediate reconstruction on my right side, with a mentor gel-filled implant. No reports of rupture or other product issues. I was hospitalized for rapid heart rate and low blood pressure. 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. I am hoping my upper back pain goes away and my health recovers. Anaphylactic symptoms. Link. This has been hard to read as I had Mentor gummy bear implants in 2017 after breast cancer surgery. 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. CL)),3dais8#(@&w[M+zK$UCS6xf ;dsfV_Z{7ayS5& uRSbhdwp[YIf!q$QajFj'Ifn{%B[O->jt/ *k`=+~(l:71s Symptoms: fatigue, endocrine issues, depression, panic attacks, insomnia, joint pain and cognitive dysfunction. Difficulty sleeping, difficulty recalling words (mixing up words), short term memory issues. 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. Update on the Safety of Silicone Gel-Filled Breast Implants, MemoryShape and MemoryGel Post-Approval Study. I had mris to check for issues with neck- diagnosed at first as herniated discs but then as arthritis. The patient was implanted with mentor smooth round gel mammary prostheses on (b)(6) 2005. However, no further information has been made available. I also have become intolerant to smells and chemicals. This study was revised/replaced into small cohort studies on 10/01/2014. Link. Mentor strongly recommends that all patients receiving silicone gel-filled . Cant handle the sun anymore, can no longer jog/run. Lived with 20+ symptoms for over 5 years. Each implant is filled with the Mentor proprietary cohesive gel that holds together uniformly and retains a natural give that better resembles breast tissue. Some days cant get out of bed. 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. I had an mri and confirmed i had ruptured my implant. FDA Recall. The health consequences of a ruptured silicone gel breast implant have not been fully established. The changes i have had in my body in the past 15 months have been so drastic for me. I am researching that option now. Also. Before sharing sensitive information, make sure you're on a federal government site. My medical bills from this are near (b)(6) and its just not right. WRONG!!!! I have been having vision problems, extreme fatigue, muscle pain, back and neck pain, hearing problems, foggy brain, stomach and intestinal issues, sore throat and cant swallow, swelling in joints and distorted looking breasts. 340 0 obj <>stream =h48(!_)L K=%.R0-&S t88/ Mentor textured silicone gel implants. Its never been ending and i cant get medical assistance to have them removed. I was systemic. Cold feet, swollen tongue, sore breast, migraines/throw up, perioral dermitis, weight gain. I had to have a double mastectomy in 2009 with immediate breast implants. I had these mentor silicone implants placed in 2007. Using DoNotPay for assistance in resolving recall issues other than breast implants is just as easy. This somewhat lessened some of my symptoms but i still felt sick like i was dying slowly. 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! Diagnosed with mid foot osteoarthritis and surgery was suggested. She became very ill and had been sick during a business trip, with a fever, swollen left breast and lymph node infection. Night sweats. Link. Weekly b12 injections. Over the next 3 years my health steadily declined with unexplained symptoms. Updated silicone gel-filled breast implant rupture screening recommendations. I did not smoke, do not use drugs, do not consume alcohol and eat very clean. Patient felt symptom-free almost immediately after removing implants. Loss of appetite, weight loss. I have 3 children and im extremely scared that im going to die from this illness. 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. Five years of being sick. I have been to several doctors and specialists over the year with no help or definite answers. Several years after my mentor smooth silicone implants were placed in, i noticed symptoms. The patient believes that the discoloration is a fungus growth inside the right device. Patient had implants explanted on (b)(6) 2016. I had upper back and neck weakness. 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. Researching implant serial numbers and tracking down your Mentor breast implant provider takes time and effort. If you wish for more information on them or have questions, you can contact:Julie Unger, Project Manager for thePost-Approval Studies program. 350-3270 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 . Link. I fortunately found a (b)(6) support group for women with breast implant illness, what i believed to have. Weight began to plummet, as did blood pressure and just all over general malaise. This is so my body can have an opportunity to try and heal and settle down from all of the reactions my body is experiencing. Alcl stage and alcl treatment are unknown. 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. I have 35 symptoms of Breast Implant Illness. I began suffering with a poor immune system, memory loss, brain fog, fatigue, insomnia, neuropathy, high blood pressure, migraines, eye sight and hearing and had to have tubes put into my ears and could not get out of bed most days. Sudden food intolerance to gluten, shortness of breath, liver dysfunction and cramping. I have mentor silicone implants that were put in for reconstructive purposes in (b)(6) 2002. 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. Six months after that surgery the left capsulized; however, surgery was not safe at the time. I will be having my silicone implants removed. Link. Case-control studies were later terminated after the release of Tuftss evidence report. In 2011 there was an update on the findings (Update on the Safety of Silicone Gel-Filled Breast Implants). Per patient, the physician woke her up in the middle of the procedure informing her of the discoloration and asked her if he could replace them, therefore the patient underwent bilateral replacement. Ive been reading endless stories online. Link. Feet red swollen to deformity. 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 . I will continue to receive services from the occupational therapist and the social worker. Ongoing recurrent infections. 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. Health product - Medical device - General and plastic surgery. I'm a 34 C with my implants. A lower risk of complication is rupture. Link. Link. This study wasto be conducted in Denmark, Germany, and the UK. (Unknown if it is Mentor saline or silicone). hb```l@(0>.JO;%.mP'cGGE[GCKGGG>aS4FeX#aD{9L'0baZ\C@Ib @w?Vf . MemoryGel Post Approval Study Seventh Annual Report, November 5, 2013. 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. After getting breast implant in (b)(6) 2013, i had hives that lasted a year. vP Per the medwatch form, extended hospitalization was required. I am only (b)(6) and should not have any of these health issues. However i had in 2010 began to be diagnosed with many more autoimmune disorders. 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