Inside, i was chronically fatigued for a very long time and the last 4 years i had to take a nap every day to get through life. Since then i have had to take coreg cr 20 mg to help my heart. 9574053 Over the years i tried countless different medications, one that actually caused me to have a seizure. 9554347 I even contacted mentor and the fda via email before and neither seemed to care. Before sharing sensitive information, make sure you're on a federal government site. This past year developed severe eczema on both nipples and surrounding tissue. 9531112 Immediately, my breathing was cured! No additional information has been received to date. I have been diagnosed with panic attacks, multiple sclerosis, r/a, fibromyalgia, chronic fatigue syndrome, raynauds disease, thoracic outlet syndrome, chronic insomnia. Shaky hands, high cholesterol, not a high fat diet. Link. I went on a (b)(6) breast explant group to solicit recommendations for explant surgeons. The patient did not receive chemotherapy or radiation therapy. The event required surgical intervention as the physician used a venous ports seal kit on the patient. 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. 9549491 Skin wound healing problems, bleeding disorder called von willebrands and severe allergic reactions, which caused me to be on life support and no other cause. Now i contacted mentor a few days ago to speak with mr. (b)(4), as i had previously asked who would help me cover the new surgeons expenses, only to find mr (b)(4) was unavailable and the new supervisor couldnt locate me like mr. (b)(4) had been able to. 9615519 300NACL. FDA Documents: Approval Date: November 17th, 2006 Recalls FDA Overview - Mentor MemoryGel [] No extended hospitalization was required. Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device. Im hoping! Over the 12 years i had them in my body. The patient reported severe nipple pain, fatigue, joint pain, hair loss, and overall sickness. I cant wait to get these things out if me, maybe then I will feel human instead if s cow with a fifty pound weight gain, pain all over my body , even the bottom if my feet burn. I got that brochure one month AFTER my surgery and it lists many potential issues, and it lists the chemical platinum being in the shell and that they are not aware if that platinum causes issues. Lot Numbers: 9584310 Link. I have become very clumsy, falling often, due to dizziness when i least expect it. As the months continued i still suffered from extreme fatigue, joint and muscle pain, and sinus issues. Extreme fatigue, migraines, digestive issues, worsening depression/anxiety, brain fog, memory issues, hair loss, numbness and tingling in left arm and leg, breast pain, chest pain. 9615516 No one should have to live like this, no one should. Also, i had 2 revisions to discover the implants were on nerves. U.S. data is current through June 2018. Please do something. 9553108 I feel all breast implants are dangerous and are killing women. 3502750/81317001522 In 2022, the global breast implant market had a valuation of just over $2 billion, and it is anticipated to grow at a CAGR of 5.0% during the forecast period, reaching almost $2.9 billion. 9535386 9614478 How will I recover this information? Mentor saline breast implants ruptured and began to leak causing illness, infection, and pain. 9580414 9537339 Link. Memory zero memory. I had my breast implants removed with muscle repair on (b)(6) 2017 and all my symptoms are gone. 9536099 It was reported that a (b)(6) female patient underwent stage one reconstruction surgery with saline smooth round spectrum implants. My brain fog is nearly gone now, and i no longer need daily naps. 3502325/81317001409 9570168 All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company. 9608795 United States This will involve obtaining responses from patients on the patient labeling format and content, generating a report of the findings, and incorporating all appropriate revisions immediately. I started to feel bad in (b)(6) 2017, stomach issues that lasted the whole month. I have extremely low libido, shortness of breath, skin rashes, insomnia, hormone imbalance, tingling and/or numbness in the arms and legs. 9586784 in 2000 i got mentor spectrum adjustable implants; 5 years ago i started getting sick. The implants were found with faulty valves and mold. Implantation of the MENTORBreast Implants, as well as any subsequent procedures, must be in accordance with current Mentor Product literature and accepted plastic surgical procedures by appropriately qualified licensed physicians for product to qualify for replacement under the Mentor Product Replacement Policy. 9546177 I hadnt changed my address in years. 9611048 9538083 This case is still ongoing as of November 2019. 9555184 9553111 I have a weak immune system, i get cold sores now, recently had an anaphylactic reaction, the list is endless. The patient didnt experience systemic symptoms such as fever, night sweat, or weight loss. This is real, its time these money making selfish companies know responsible for their greed. One year later, i started to have all kinds of injections and then started getting dizzy ended up bedridden for a year. I have breast implant illness and will be having the implants explanted very soon. The FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace. Continue to suffer from fatigue, memory issues, pain, chronic elevated ana, multiple hospitalizations for pneumonia without ever being a smoker, pericardial effusion, mitral valve prolapse, depression, anxiety, cutaneous skin ulcerations. The report states candida albicans in both breasts between the implants and capsules. Over the next 6 years i began to experience various symptoms such as daily headaches, insomnia, anxiety, and brain fog that i just wrote off at the time. Within 3 months started having pain. I have spoken to the manufacturer. I stopped making any strength or cardio goals and also gained about 25 pounds slowly over the following 3-4 years. 9559144 Mentor Texas LP. 9543626 Years later dr diagnosed me with autoimmune illness, fibromyalgia, sjogrens syndrome, interstitial cystitis, memory problems, concentration problems, corrective tissue illness and problems finding words when talking. Some symptoms have already gone away and some have gotten better. 9569246 The physician had to put tissue expanders instead and schedule an additional surgery. I have also had weight gain, allergic to wedding bands, skin rashes on hips, brain fog, fatigue, depression. From the moment they were put in my body, my immune system reacted to everything. Heat and cold intolerance. I havent even had a cold for at least 2 years or more. Patient had implants in for 10 yrs. Per the contact, there was no significant procedural delay, and the procedure was completed with a fill valve that the hospital had available. Link. 9530518 I have seen over 35 doctors through my 18 years of nightmarish hell and have had upward of 20 plus diagnoses. 9547975 9550164 Thank you friend, hope youre feeling better! I was a health woman before I put them in and wish I never had. My sickness started about a year later. Adrenal fatigue, hypothyroidism, hashimotos, back and shoulder pain on left side, lower back pain left side, heart palpitations. He sent me on a chase for medical records 23 years old. 4. Clinical data reveals the lowest reported incidence of key complications in primary augmentation at 10 years. Implanted with mentor textured implants in 1996. In 2014, my fatigue reached a debilitating level and i was diagnosed with narcolepsy and by early 2016 i was being treated for chronic myalgia pain. By (b)(6), i began experiencing multiple sclerosis-like symptoms such as cramping muscles, vibrating/ electrical sensations throughout my body, continuing numbness and tingling in my limbs, continual muscle spasms, sore muscles, fibromyalgia, ear ringing, and a constant vibration sensation inside of my head. 9528840 I hope your explant was successful. Link. my first ones were removed via the area incision and now i have an incision in the inframammary location. I was tested for a multitude of disease such as lyme, eb, anemia, ms, als, etc. 9578064 I found great difficulty concentrating and working fast as i became easily fatigued, but was still working. Implants should be taken off the market, they are so hazardous to our health. I was informed that many women are having similar issues that have breast implants. In 2002 i began having health problems. 9558852 My skin was aging rapidly the last year, and now that the implants are out, the age spots have lightened and i have been complemented on my glowing skin again. My feet were constantly sore and i had to replace my arch supports every 30-60 days because it was like walking on bones, my foot doctor said my bottoms of my feet were the thinnest he had ever seen. 9534354 Rashes = gone. I am now in addition to suffering from a myriad of diseases (some not confirmed via scans etc) suffering from extreme stress, case has been escalated with (b)(6) and right implant has deflated on this date of (b)(6) 2017. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. My symptoms: fatigue or chronic fatigue cognitive dysfunction (brain fog, difficulty concentrating, memory loss), muscle pain and weakness, joint pain, hair loss, dry skin and hair. Breast implant illness. I had lime green nipple discharge on the right side and blood coming out the left breast nipple. Fevers, night sweats, intolerant to heat/cold, new and persistent bacterial and viral infections, slow clearing of common colds and flus, fungal infections, yeast infections, candida, sinus infections, skin rashes, ear ringing, sudden food intolerance and allergies, headaches, slow muscle recovery after activity, heart palpitations changes in normal heart rate or heart pain, sore and aching joints of shoulders, hips, backbone, hands and feet swollen and tender lymph nodes in breast area. Lost his license for 3 years, hes practicing again. 9611602 9538573 3501630/81317001218 9604455 Capsular contracture and fungal growth were diagnosed in both breasts/implants upon explantation. 9578063 I was told by my surgeon that since silicone was banned that i would need special approval to get these implants. Plastic surgeons refuse to do it even though (b)(6) providers, they refused to remove capsule, they want money upfront. I even developed (b)(6) 3 weeks after the surgery under my armpit, which ive never had. MENTOR Saline-Filled Breast Implants are inflated to the desired size with sterile isotonic saline before implantation, as well as postimplantation. The patient has no history of medical problems. Link. This is outrageous! It was the breast implant on the left side pulling my chest wall back causing my left scapular to wing out. Frequent urination, numbness/tingling sensations in upper and lower limbs, cold and discolored limbs, hands and feet, general chest discomfort, shortness of breath, pain and/or burning sensation around implant and/or underarm, liver and kidney dysfunction, cramping, toxic shock symptoms, anxiety, depression and panic attacks, leaky gut, ibs and sibo symptoms of or diagnosis of fibromyalgia, symptoms of or diagnosis of lyme disease, symptoms of or diagnosis of auto-immune diseases such as; raynauds syndrome. The action also notes Mentor had poor follow-up rates with patients in the study. 9561193 A few years ago i was having hormone inbalance issues. Link. The patient reports that her health is slowly improving but the nipple pain resolved immediately after explantation. There was a stalling hair loss for a period of time, but resumed fall out with complete hair loss by (b)(6) 2014. 9594634 9547111 9540919 Antecubital trigger thumb release, frozen shoulder release, chiropractic manipulation for several back problem etc. 9535773 Mr. (b)(4) had requested me to write an email, stating my health issues, and the need for help to get the ruptured implant out and because i was unique out of the box situation he would be forwarding it to mentor legals department to see what they are willing to do. 9534031 I was healthy prior to 5 years ago, currently show autoimmune symptoms with neg blood work. 9559882 9556607 I have chronic joint pain, fatigue, anxiety, migraines, hair loss, and many other issues. 9607486 A focus-group study to obtain immediate feedback on the patient informed decision brochure from both augmentation and reconstruction patients. These incidences spontaneously resolved. 9558222 Was the surgery difficult and painful? Copyright 2016-2022 BreastImplantIllness.com. I now have heart issues, elevated blood pressure, inflammatory arthritis, lyme disease, morgellons, ulcerative colitis and neuropathy. Health product recall MENTOR Saline Breast Implants Brand (s) Last updated 2022-03-10 Summary Product MENTOR Saline Breast Implants Issue Medical devices - Premature failure What to do Contact the manufacturer if you require additional information. The only diagnosis i was able to receive was that i had anxiety. Link. I underwent treatment for this. I received my first set of implants in 2005. I was on biologic drugs several years without any relief of joint pain or swelling. 3503270/81317001614 9608794 Functioning in life is difficult and painful. 9547973 I began to be light headed and eventually full blown vertigo episodes. 9555187 I had 3 healthy boys regular delivery. Any problems with tissue expanders being left in for a few years. The FDA issued warning letters to Mentor Worldwide LLC of Irvine, California, and Sientra, Inc. of Santa Barbara, California. capsule had gone away? Lot Numbers: 3501625/81317001201 The correlation makes sense to me. Years later i was diagnosed with copd and for 6 years. 9555185 9565269 9620460 Post-approval requirements are critical to ensuring the safety and effectiveness of the medical products we regulate and well continue to hold manufacturers accountable when they fail to fulfill these obligations, said FDA Commissioner Scott Gottlieb, M.D. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. This cancer occurs more commonly in patients with textured breast implants than smooth Implants, although rates are not well defined. 3503330/81317001645 MENTOR MemoryShape Breast Implants MENTOR Saline Breast Implants FDA Approved Made in the USA Implant Fill Proprietary cohesive gel which holds together uniformly to better resemble a more natural look and feel Proprietary highly cohesive gel that retains shape and has a natural feel. I have suffered numerous health problems that i now attributed to the implants: chronic fatigue, cognitive dysfunction, muscle aches, joint pain and soreness, hair loss, dry skin, eyes, mouth, easy bruising and slow healing of wounds. Lot Numbers: 3501690/81317001317 I was treated by several different dermatologist with steroids im as well as into the bald patches on my head. Two Florida women filed a $5 Million dollar lawsuit against Allergan as a result of the recall. Mentor saline breast implants caused hashimotos and sjogrens auto immune. Shortness of breath, frequent urination, numbness/tingling sensations in upper and lower limbs, ear ringing, sudden food intolerance and allergies, vertigo. (b)(6) address change datasheet with (b)(6). 9578299 In 2008, the patient has a bilateral revision augmentation due to capsular contracture with unknown implant brand, texture, and fill. 9540917 9631722 During routine set up, the physician found that the package of the implant did not contain the dome pack accessory. 9580874 By 2007, my health issues had progressed with increased fatigue, emotional lability, gastrointestinal problems, and increased breast pain. Many of having symptoms even much worse then i. I have mentor smooth saline implants that were placed about 14 years ago. Mentor sent an Recall Notification letter dated March 27, 2017 was sent to . 9576452 6. I had an ultrasound which showed nothing and I am now waiting for my dr. to get back to me. 9559516 3502425/81317001447 Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. I have actually been sick since 2004, but your calendar only goes back to 2007. 9629900 9531109 The FDA requested the voluntary recall from Allergan after a "significant increase" in cases of a . 9565271 I have fallen and injured my cervical spine two times requiring surgery with hardware for stabilization. 9571294 I cant wait for my healing to continue and get my life back. 9550485 9610037 I have also had surgeries for those joint problems. 9615895 3502375/81317001423 His name is Dr. Bradford Roberg in Crystal Lake, IL. No relief after surgery. I had very high levels of several heavy metals in my blood. Lot Numbers: 9579266 Get notified instantly when recalls like this are issued. Lot Numbers: 9566957 She also reports headaches, brain fog, joint pain, body aches, chronic fatigue, dry eyes, weight loss, digestive system issues, sore feet, and increased recovery period from any surgery. It was reported that the patient was diagnosed with bia alcl after using mentor saline implants. 9551034 9532947 9538572 Link. 3501620/81317001195 Link. I want to share it with the world so no one else has to endure the pain and suffering the implants have caused to me and my family. 9544819 Researching now to have my implants removed. Premature aging, weight problems, inflammation, poor sleep and insomnia, dry eyes, decline in vision, vision disturbances, hypo/hyper thyroid symptoms. In (b)(6) 2017, i learned about breast implant illness or autoimmune syndrome induced by adjuvants. 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