Patient was under general anesthesia for 4 hours (from 7:46am to 12:06pm). Lot Numbers: We expect these manufacturers to meet the pre-specified study requirements in order to ensure the collection of long-term data that can be used to inform long-term patient safety. Lot Numbers: Left implant had evidence of blackish fluid within the implant. 6. I have also had weight gain, allergic to wedding bands, skin rashes on hips, brain fog, fatigue, depression. Remaining optimistic food will be my medicine (magic wand &/or reset button). 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. 9612274 I still didnt know if the cause of my health problems was the implants, but it was like looking into a mirror. There was no previous history of autoimmune disease. Hence, follow ups for further investigation could not be performed. Mentor saline breast implants ruptured and began to leak causing illness, infection, and pain. 9610033 Im scheduled for lumpectomy and also explant. 9554347 I am bedridden at (b)(6). I was informed that many women are having similar issues that have breast implants. No patient consequence was reported. I got my implants in 2010. It was further reported that the surgeon used fill tube from secondary implant that was used for contralateral side. Some patients have died from BIA-ALCL. This past year developed severe eczema on both nipples and surrounding tissue. 9530918 Any news on this condition and Link. Link. What is your recommendation? Extreme anxiety, numbness tingling, severe joint pain, brain fog, memory loss, confusion, vision problems, major food allergies, difficulty walking, malabsorption, breathing issues, muscle atrophy, hormonal issues. Lot Numbers: I even developed (b)(6) 3 weeks after the surgery under my armpit, which ive never had. There is not a recommendation that women who have had these implants placed explant them. 9543358 3502375/81317001423 9544819 Body odor every hole chemical sensitivity. 9606471 9606468 I even contacted mentor and the fda via email before and neither seemed to care. Today, the U.S. Food and Drug Administration issued warning letters to two breast implant manufacturers for failure to comply with their requirements, under their premarket approval orders, to conduct post-approval studies to assess the long-term safety and risks of their silicone gel-filled breast implants. This was an anatomical change in contrast to the 2017 study. July 30, 2019 Answer: Implant recall and breast implant removal The recall of Allergan Biocell textured implants applies to implants that are on the shelf. 9592611 This needs to end. 9528839 9551039 the patient underwent testing but everything returned negative for disease. Link. I thought maybe an expander that would be placed between the muscle and tissue to push the muscle back down to the chest wall or maybe stitches to stick the muscle back down so that its not pulling the breast tissue when i flex. I have my receipt, and physician doctor appointment pre-op information, warranty sheet, but no data on serial number, style or lot number. 9587067 I had my Mentor implants placed in 2004 and my health deteriorated after that. Was told by so many drs that i needed depression medicine. Some symptoms have already gone away and some have gotten better. 9538080 They should be remove from all surgeries. Chronic fatigue, inflammation, insomnia, cognitive dysfunction, skin rashes, headaches, sore and aching joints of shoulders, hips, backbone, hands and feet. 9607487 The implants were found with faulty valves and mold. Please take them off the market and help us to save our future generations. Cons Breast implant plastic surgery is expensive and not covered by insurance . July 29, 2019. Mentor Saline-Filled Breast Implants - FDA Information Scroll down for a list of symptoms women have reported to the FDA and for reports of mold, manufacturer issues, BIA-ALCL, other cancers, body parts removed, and pre and post approval study follow-up. I requested pathology be done. Both functional med and regular doc over (b)(6) dollars worth. 9543626 All the plastic surgeon will offer me is a lift on my good breast, which she already reduced in half in 2015 with large lumpectomy. 9591675 Lot Numbers: 9612273 9575829 The most common complications for breast reconstruction with MENTOR Saline-filled Breast Implants include re-operation, implant removal, capsular contracture, breast pain, and implant deflation. The patient reported severe nipple pain, fatigue, joint pain, hair loss, and overall sickness. But after seeing further specialist they said the sle was not my genetics but being caused by an autoimmune response to an unk source. Immediately and every day since my surgery 3 weeks ago, ive had all of the same symptoms reappeared but even worse. Per the contact, there was no significant procedural delay, and the procedure was completed with a fill valve that the hospital had available. I have lost the last 13 years to being sick and have an appointment tomorrow to have another mammogram and ultrasounds to begin testing for bia-alcl. 9546177 3502475/81317001461 3502550/81317001485 People are so so sick and we had no warning of any of this prior to getting those toxic bags put in our bodies! 9553670 I was treated by several different dermatologist with steroids im as well as into the bald patches on my head. 3501695/81317001324 Since focusing on nutrition to reduce inflammation, i have lost at least 5 pounds and this is only the beginning to my recovery. I have had Mentor Saline since 2009. Which led to an ablation attempt and eventually ended with hysterectomy last year. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. I cant wait for my healing to continue and get my life back. 9582571 Which I was not asked to participate in, nor aware of. My implants were put in in 2008 and were Mentor Saline Implants. Extreme fatigue and the inability to make it through my daily tasks without hours of napping. 9611045 9541226 I have fallen and injured my cervical spine two times requiring surgery with hardware for stabilization. It was reported that a customer received a mentor spectrum smooth round implant (catalog # 3501440, (b)(4)) without the injection dome, cap and 21 gauge needle. I have no family history of auto-immune disease. Report physical symptoms of severe back, breast, thoracic rib pain, neck pain, difficulty sleeping and i told him that i thought left implant had a slow leak. 9545545 9543989 9567889 It was reported that a female patient was implanted with mentor smooth saline breast implants in 2002. I grew up very athletic, so this was like dying. The date above is around the time that i had my mentor saline breast implants put in. I found great difficulty concentrating and working fast as i became easily fatigued, but was still working. 9585571 9557442 So I called Mentor, they have his name in their data base, but say he didnt report any implants nor did he place an order for an implant until December of 2001. As part of the Medical Device Safety Action Plan, the FDA committed to streamlining and modernizing how the agency implements postmarket actions to address device safety issues to make responses to risks more timely and effective, including taking actions against manufacturers when their postmarket studies are non-compliant with any study requirements. 9530516 9546178 9528578 Ever since that surgery, i had left scapular pain. 9540916 9541783 9569248 9620460 Lot Numbers: 9537342 On 10/11/2021, the Firm sent an "URGENT MEDICAL DEVICE RECALL (REMOVAL)" Notfication via UPS informing customers that breast implants which have expiration dates from 01/01/2025 to 09/30/2021, due to a manufacturing issue may have a potentially weakened area on the base patch portion of the shell. 9567251 At no time did i connect the rashes, joint aches, or weight gain (heck i thought it was menopause) to the breast implants. Then, my ana, c-reactive protein and other tests were elevated. 9580873 I went to see dr. (b)(6) in (b)(6). 9541787 Lot Numbers: We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. 9535778 9568918 9569246 9550673 I am having horrible issues and what mine out! Ladies need to be made aware this can happen to them so they can make the decision to risk problems. I started having serious difficulty breathing at all times, and especially when laying down at night. Instructions for Downloading Viewers and Players. 9541465 9582573 The patients known implant history is the following: the patient had bilateral augmentation in 1992 with unknown implant brand, texture, and fill. The patient was treated with chemotherapy and radiation therapy. 9576454 Mentor Worldwide LLC) passed preemption in part(s) and are proceeding to jury trial. 3502425/81317001447 I had breast implants in 2005, mentor smooth round profile saline. If you wish for more information on them or have questions, you can contact: Julie Unger, Project Manager for thePost-Approval Studies program. 9546777 9563098 At the age of (b)(6) my vision started to go. This is outrageous! Don't be at the mercy of a late news segment or a social share. Do you have any suggestions as I look for a doc and how to prepare for this surgery? The FDA issued warning letters to Mentor Worldwide LLC of Irvine, California, and Sientra, Inc. of Santa Barbara, California. Link. 9599496 3. Follow instructions in the letter and immediately return any inventory of MENTOR Smooth Round Saline DV Breast Implants with expiration dates ranging from 01/01/2025 to 09/30/2025 subject to this recall to Sedgwick. Ive had multiple lyme tests done that were all negative. By sunday (b)(6) left implant was deflated, there was bruising of breasts from traumatic fall. 9574860 9527435 Recall Monitor is not endorsed by, or is an official product of the Government of Canada. Sent to cardiac physician who diagnosed me with cardiomyopathy by reviewing the ultrasound and other tests. Adrenal fatigue. Eye floaters, hip pan, can barely walk after sitting. Capsules were thick, yellowish and my chest full of yellow murk liquid. It was bought to my attention by my new functional medicine doctor that i could be having an autoimmune response to the implants. I have had years of extensive testing done. It was reported that the inside of the valve and the outside of the implant had mold. 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 have chronic symptoms such as bone pain, neck and back pain, brain fog, severe fatigue that affects my concentration and driving, stomach and digestive issues, and eye problems, etc. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. My aerobic capacity diminished and recovery from my own personal workouts was long. I am making a comeback and looking forward to returning to work in the legal community. I was a health woman before I put them in and wish I never had. 9537341 9550674 9596396 U.S. data is current through June 2018. 9529385 After my breast augmentation, i started to get intense neck and shoulder pain along with numbness in my hands and fingers. 9584310 9567249 9530916 2. 9595425 Link. Hi Laura, 9605660 I think my immune system started deteriorating in 2010, however, being so physically fit, the symptoms were masked until 2013. My body took twice as long to recover from surgery, childbirth, and everything in between. 9552229 MENTOR Smooth Round Saline DV Implant 350-1697/00081317001331 I have spoken to the manufacturer. 9589650 I had my breast implants removed with muscle repair on (b)(6) 2017 and all my symptoms are gone. 9570473 Link. How is your recovery going? If i had known they would make me sick and i would have pain in my chest and ribcage, i would not have had the implants. 6. There is hope!!!!! 3501640/81317001232 My brain fog is nearly gone now, and i no longer need daily naps. Further on March 22, 2021 in Philadelphia, the law firm Berger Montague announced that many claims for injuries arising from the recall of Allergan's Biocell textured implants will now proceed to Discovery, read more here. I also developed tingling and pain in my hands and itchy pains and a numb right thumb. 9555926 Link. Is this silicone? 9615896 Ultimately, i have been diagnosed with celiac disease, vitiligo, rheumatoid arthritis, hashimotos, lyme disease and a liver disorder, among many other accompanying side effects (anxiety, depression, fasciculations, ringing in ears, heart palpitations, memory loss, migraines, hormone deficiency and many others). After surgeon removed the implants, my health has improved by at least 90 percent. 9547976 Also started experiencing whole body muscle pain with joint pain, extreme fatigue, and digestive disorders. Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. Lot Numbers: Patient was required extended hospitalization. The FDA advises women with BIA-ALCL to have their implants removed. I got mentor saline breast implants and right after stated having symptoms resembling ms joint pain, confusion, numbness, brain fog, hormone issues resulting in hysterectomy at (b)(6). 9553108 3502800/81317001539 9538574 9561863 It was not feeling well at all. Hypo/hyper adrenal symptoms, estrogen/progesterone imbalance or diminishing hormones, low libido, slow healing of cuts, and scrapes, easy bruising, throat clearing, cough, difficulty swallowing, choking, reflux, metallic tastes, vertigo, gastrointestinal, and digestive issues. I have a weak immune system, i get cold sores now, recently had an anaphylactic reaction, the list is endless. I have all the same symptoms and after finding a site for women in the Northwest with the same problems I am taking them out. 9588333 One year later, i started to have all kinds of injections and then started getting dizzy ended up bedridden for a year. Mentors failure to address these concerns and comply with its post-approval study requirements is a violation of the firms pre-market approval order. Link. 9564916 Link. Link. I was never contacted and i was more than easy to find. I have become very clumsy, falling often, due to dizziness when i least expect it. Capsular contracture and fungal growth were diagnosed in both breasts/implants upon explantation. I developed reoccurring breast cellulitis due to 10 year old saline breast implants. Is saline considered a gel? 9614480 9532948 13 December 2022 Listen In October 2019, the TGA took steps to improve the safety of breast implant products in Australia. I dont want to be sick, but what can I do? It has been 1.5 years. 9602500 In 2005, i had mentor smooth saline implants placed above the muscle. I am not sure whether I have saline or silicone. 3503460/81317001676 All i want is for my original breasts to look normal and not have the muscle flex deformity. I ended up going to a gastroenterologist and was diagnosed with ibs. Now Im full blown deteriorating. I recently explanted in (b)(6) 2016. 9615898 Link. I have had numerous disabilities and health issues ever since ranging from thyroid issues, chronic fatigue, cognitive dysfunction, muscle pains and weaknesses. 9577403 I had a full hysterectomy six months after getting the implants. 9536098 Night sweats to literally being soaked in sweat with a fan blowing on me. It was reported by a physician that a (b)(6) caucasian female patient who underwent multiple breast augmentation procedures was diagnosed with bilateral stage ie alcl on (b)(6) 2016. In (b)(6) 2017, my muscles began to spasm and twitch constantly all over my body. How many years did you have them in??? 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 Recall terminated December 9, 2016 Symptoms and Side Effects of Defective Breast Implants 1. Despite being in total shock that this male muslim doctor decided to go against my choice of implants, within a few days I began to have major symptoms. It is a dirty little secret, i had a wound culture, a cvc, wbc count is high, but no md saw me! 9553109 9564915 Cause 2. Antecubital trigger thumb release, frozen shoulder release, chiropractic manipulation for several back problem etc. There are to many women out there with the same story! I had many headaches and so much brain fog that it was difficult to do my job as an actor who is supposed to memorize lines. I met with two surgeons which confirmed breast implant illness for me and i then scheduled my surgery for (b)(6) 2018. Link. Were issuing these warning letters based on the manufacturers low recruitment, poor data, and low follow-up rates in their required post-approval studies. Link. 9556177 I became very sensitive to many foods, smells, lights, sounds even. The implants were intact upon explantation. Got my implants removed after 8 years in 2015 and 75 percent of the symptoms went away. Link. According to U.S. Food and Drug Administration, this recall involved a device in Lot Numbers: Was given two weeks to live if no treatment. Lot Numbers: Additionally, the FDA has worked with multiple stakeholders to facilitate the development of the National Breast Implant Registry (NBIR) to provide a platform for collecting additional real world data on the safety and performance of breast implants. Therefore, explanted in (b)(6) 2018. Why cant older women get sagging implants?? 9611044 9614772 3502600/81317001492 9535385 This price does not include mastopexy (breast lift). Its as if their symptoms mirror some of which Im suffering from. Mentor saline breast implants in 2001 over the muscle. Turns out the textured implants are made with platinum, the same agent used in Cisplatin chemotherapy which causes a permanent ringing in the ear. I got breast implants and theyve made me very sick. 9576297 9538572 9617100 9559142 Hashimotos thyroiditis, rheumatoid arthritis, scleroderma, lupus, sjogrens syndrome, nonspecific connective tissue disease, multiple sclerosis, symptoms of or diagnosis or bia-alcl lymphoma. Among many symptoms that make me feel like im dying a slow death. Link. There was a stalling hair loss for a period of time, but resumed fall out with complete hair loss by (b)(6) 2014. I am currently in the process of trying to have the implants removed but insurance, of course, does not want to pay for explant and all prices were anywhere from (b)(6) to (b)(6). I began to be light headed and eventually full blown vertigo episodes. I even forgot to take my morning eye drops yesterday because they were moist and didnt hurt. 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. 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. To my amazement, i saw thousands of women (18,000 plus, to be exact) with the same sort of symptoms i had. The restrictions on sale and distribution are included in the Post-Market Approval (PMA) Supplement Approval letter for these implants. 9527434 9559143 Lot Numbers: Link. I had a metal taste in my mouth, tinnitus, chronic pain, chronic fatigue, depression, brittle hair and nails with ridges, +ana test, thyroid levels off and left scapular pain so bad i wanted to overdose and die. 9555927 9590274 9617820 9550165 Two Florida women filed a $5 Million dollar lawsuit against Allergan as a result of the recall. Lot Numbers: Your complete guide to recalls, "breast implant illness," and the conversation surrounding them. All of this symptoms that are listed I deal with daily along with and more recently, breast pain and tingling. 9535131 9540917 9576296 Life became so difficult at times that i became severely depressed at one point.