Dry eyes, blurred vision, double vision, and eye pressure. of Irving Texas initiated a recall of their MemoryGel breast implants on July 01, 2016, due to a labeling mix-up, Consignees were notified by mail and a follow-up visit by a sales representative, Hardening of the breast or area around implants, Pain, tenderness, swelling, burning, or numbness. I have many chronic illnesses that i never had before including: pain in my breasts, joints, bones, arthritis, migraine headaches and dizziness, aversion to smells and taste, dry skin, canker sores in mouth, throat and swallowing problems, chronic fatigue, memory problems, gerd, insomnia, ear ringing, restless leg syndrome, forgetfulness, anxiety and panic attacks, swelling, inflammation all over body, weight gain in upper extremities. Link. I have been ill for past several years with autoimmune illness. Began with pain in joints/muscles of the neck, led to other infections and weakened immune system, followed by growing pain in joints and extreme fatigue. Instructions for Downloading Viewers and Players, Class 2 Device Recall Mentor MemoryGel Breast Implant. Over the past 3 years i have slowly begun to improve. Choose whether you have the capacity to return the item or not. I have ulcers on my fingers that will not heal. FDA Documents: Approval Date: November 17th, 2006 Recalls After approximately 1. Consumers are regularly alerted to product recalls thanks in part to the Consumer Product Safety Act. If I had been told that any of these possibilties, I never would have had them put in!!!!! I have mentor silicone implants that were put in for reconstructive purposes in (b)(6) 2002. Teague urinary incontinence, dry skin, sjogrens autoimmune, hair loss, burning around the breast tissue, two air forms of thyroid cancer, chronic fatigue. Now all i want is my life back. Rushed to surgery for third time. The hospital has denied the mammogram caused the rupture but both at the same time is so obvious. To be able to walk and have energy again, and hopefully for the arthritis symptoms to diminish. 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! Patient felt symptom-free almost immediately after removing implants. I was implanted with mentor memory gel silicone breast implants. 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. I havent even had a cold for at least 2 years or more. A lot of my symptoms have improved or disappeared after removing the implants. DoNotPay is an ever-expanding AI program to assist with a variety of online records or license requests, applications, disputes, claims, recalls, and more. 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. Her email is [emailprotected] and phone number is (301) 796-6134. Now i am homeless. Since the removal of the implants, i have had 2 addl reconstruction surgeries including a latissimus flap. Skin issues were addressed with various creams/meds, none which resulted in improvement. endstream endobj 312 0 obj <>stream Worsened over a period of 5-7 years post implant. 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. A bilateral breast mri was done on (b)(6) 2017 due to recent diagnosis of left breast cancer (exact date of diagnosis is unknown) the mri was done to assess extent of disease and for possible contralateral disease. Loss of interest and pleasure in doing activities. This study wasto be conducted in Denmark, Germany, and the UK. CL)),3dais8#(@&w[M+zK$UCS6xf ;dsfV_Z{7ayS5& uRSbhdwp[YIf!q$QajFj'Ifn{%B[O->jt/ *k`=+~(l:71s 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. I went to the er, where they werent sure what was wrong and gave me antibiotics, which had no effect. Link. )7:Evvc},,dK9%"Ty.73&X6H(TQzz?n7?"=O[U? In doing my research, i trusted the fdas recommendation that these were very safe implants. 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. As of(b)(6) i no longer was able to work. 1* Choose from a wide range of sizes and profiles including Moderate Classic, Moderate Plus, High, and Ultra High. it looks like thats what i am coughing up sometimes like i said its extremely sticky. (b)(6) of this year started a severe decline in my health. I am only (b)(6) and should not have any of these health issues. Lowered immune system, and i get sick (strep throat, colds) and i never used to, slow clearing of colds. From the middle of (b)(6)(the date my plastic surgeon explanted the implant), i became so debilitated that i could no longer walk. Arthritis in my hands, swollen feeling, vision issues, hypothyroid, hashimoto, crepe like/dry skin. Was rushed to surgery, large hematoma was removed and hospitalised for several days. Some respondents suggestedthat the true purpose of the brochure was to protect Mentor, rather than inform patients about breast implant surgery. No harm came to the patient. 5 post implants. From that time on, i developed more and more symptoms that piled on top of each other. At least make every day doctors like rheumatologists aware that this is happening, and what can happen if they dont treat it right away. Neck, shoulder pain along with tension on where my head and spine meet. 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. I have a supportive husband and family and have even resigned from my teaching position to help figure out my medical issues. Implants should be taken off the market, they are so hazardous to our health. I got so sick so fast and did not know why. i have been so sick i feel like i have to try getting them out to see if i have a chance to get some sort of my life back. Physician did not perform any pathology tests. Muffled ears like swimmers ear. Posting Date. I have been to several doctors and specialists over the year with no help or definite answers. Five years of medicating my body when it was trying to say please get these out of me. Link. a few months later things went downhill fast! Previous to implants i was on medication for thyroid issues, but nothing else and was in very good health. Memory problems, disturbing enough to affect me emotionally as well. I had mentor silicone breast implants in (b)(6) 2007. I can hardly walk, my knees lock up, and i am only (b)(6), depression at times, due to weakness. 350-3460. Dermatologist and allergist were seen without relief. I have night sweats, i get insomnia, i have a couple different autoimmune diseases that have come about. Only need to get an mri if you suspect a rupture or feel contracture. Patient suffered pain on the left side for the past year and it was getting worse. Since this event involves device sterility and could have led to an adverse event or serious injury, it is considered serious and mdr reportable. Dryness of mouth, hair, skin, and scalp sores, choking at night afraid, i wouldnt wake up. 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. 1. Patient was scheduled to have mri exam later. The surgeon noticed a piece of plastic that was attached to the outside of the shell. They were hard as a rock from the beginning and extremely uncomfortable throughout and especially toward the end. 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. I was no longer able to work and was placed on disability. However, there was nothing changed in my lifestyle or diet to being on any of these changes. Other diagnosis are for fibromyalgia due to the chronic pain i suffer. I had the implants removed at the end of 2015. Within two months of my operation, i had an odd perspiration odor which remained with me permanently. Within several months i developed capsular contracture in r breast. Patient was bedridden. Over the next 3 years my health steadily declined with unexplained symptoms. Now that ive seen the reports on tv and the studies associating silicone implants with a certain type of cancer. I experience brain fog, trouble recalling words and im only(b)(6). 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. These are mentor memory gell 450cc breast implants still in me. Ringing in ears, metalic taste in mouth, skin rashes bug bites, scratches and other wounds take forever to heal. 5. 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). Skin rashes only getting worse and slight fibromyalgia diagnosed by dr. (b)(6). Link. Released and left breast began to swell, i ran a fever, chills, severe headache behind my eyes, nausea, fever. 350-1625 Avoid delays that will only cause undue stress, worry, or possibly affect your health by using DoNotPay. Since that date my health has steadily declined with a fast decline noted after 2. Bruise easily. Per the medwatch form, extended hospitalization was required. Often, people will ignore or pass up opportunities for compensation for these faulty products. Alcl stage and alcl treatment are unknown. They had migrated to under my arms!!!!! 350-1655 Link. I was fine for the first two years. Have had multiple visits to the ent and walk in clinic. They admitted me and performed exploratory surgery, found I had a ruptured right fallopian tube, which they removed. MemoryShape PostApproval Cohort Study (formerly Contour Profile Gel Core Study) Final Clinical Study Report . Manufacturer requested implant and packaging directly from or team to investigate. I was a 34 B previously. Link. I finally found out that this is the brand I have for about 10 years nowI just thought I was having symptoms of getting old, until I heard about BII.now I realize that every thing that is wrong with me I have read about on BII sites..Now, what do I do? Link. Night sweats. Thank you for the many experiences posted. In (b)(6) of 2016 the implants were explanted and reported to be filled with mold. No reports of rupture or other product issues. Link. 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 had mentor cohesive gel implants placed. Two weeks after getting great implants, lymph nodes began to swell and are still swollen. Mentor Texas LP. I noticed it has a Ribble in it, and it has a bubble, the bubble caves in when touched. I lost 20lbs of muscle during this above-noted period, as my arm, leg and rear muscles atrophied, resulting in me being totally debilitated. Link. Cold feet, swollen tongue, sore breast, migraines/throw up, perioral dermitis, weight gain. 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. 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. I have been extremely sick about 1 year after surgery. I have this implant, I had it 4/2017. I am convinced that all of my problems stemmed from the holes in them. It was reported that a patient alleged autoimmune-like symptoms after using mentor memory gel implants. Site of lymphoma: right side. But since the surgery i feel like my lymph nodes are constantly swollen and keep struggling to fight off infections and colds. Then upon investigating, i found that all of my symptoms were related to silicone poisoning due to ruptured implants. My medical bills from this are near (b)(6) and its just not right. I applied for social security disability and as approved. Weekly b12 injections. No patient consequences were reported. I was able to have a visiting nun come once a week also. Link. 350-3270 Link. In 2012 while leaning over the side of tub, i heard a pop, experienced a sharp shooting pain that went straight thru my left breast. Breast implant manufacturers may need to update product labeling as the FDA learns new clinical information. Bad gastrointestinal and digestive issues, nausea, intense night sweats and hot flashes, poor sleep and insomnia, anxiety and depression. my first ones were removed via the area incision and now i have an incision in the inframammary location.