The report states candida albicans in both breasts between the implants and capsules. I also had an emg conducted and saw a separate neurologist within the veterans affairs hospital who were also not concerned. 9594296 9570169 Link. 9554347 I still struggle with gut issues and joint pain. 9544818 9528580 9570166 3501695/81317001324 9617818 Link. By (b)(6). 9600888 This has been going on since Monday. Since focusing on nutrition to reduce inflammation, i have lost at least 5 pounds and this is only the beginning to my recovery. Patient was under general anesthesia for 4 hours (from 7:46am to 12:06pm). 9577403 Link. There is no invasion beyond the fibrous capsule into breast parenchyma. I had very high levels of several heavy metals in my blood. in 2000 i got mentor spectrum adjustable implants; 5 years ago i started getting sick. 9555925 9530518 9614988 9531111 Any non-affected product and any product returned after the dat. Every part of my body was shutting down and no dr. Could tell me why. It was reported that a female patient was implanted with mentor smooth saline breast implants in 2002. How many women must get sick? Exercised regularly prior and now extremely limited. I think 90 percent of the symptoms I have. Cheryle July 30, 2017 at 2:53 am In 2007, my saline implants were replaced with Mentor Memory Gel. Breast implant illness is a real condition and needs to be explored further and of public health concern. Link. So many BII symptoms, this isnt living. 9582183 i no longer had shortness of breath. Temperature intolerance even if the house is 77 degrees during the summer, i have sweat clothes on. Mentors failure to address these concerns and comply with its post-approval study requirements is a violation of the firms pre-market approval order. I also tested positive for lyme disease. Lot Numbers: Link. During routine set up, the physician found that the package of the implant did not contain the dome pack accessory. On (b)(6) 2005, i replaced silicone breast implants (which i discovered had capsular contraction in one and the other was ruptured) with mentor smooth saline implants with the assurance that they were safe. 9586784 3502800/81317001539 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. Approximately two weeks after the procedure, the patient began to experience a number of symptoms, including extreme anxiety, numbness, tingling, joint pain, brain fog, memory loss, confusion, vision problems, food allergies, difficulty walking, breathing issues, muscle atrophy and hormonal issues. It stated that the implant did come in contact with patient. Im scheduled for lumpectomy and also explant. I am very healthy, eat healthy, exercise, and live an overall healthy lifestyle. After approx 7 yrs i started having problems communicating. 9595427 I had suffered from thyroid disease, autoimmune disorder, hashimotos and p. O. T. S. Ive had to have a full hysterectomy, remove my gallbladder, appendix, and part of my colon out, all by (b)(6). Lot Numbers: 9566958 9592611 July 29, 2019. Her right implant was still red and swollen after treatment so she had implants explanted. If additional information is received, a supplemental 3500a report will be submitted. Link. I did research what i could find previous to getting my implants and found no negative reports at that time. 9586783 Chronic fatigue, inflammation, insomnia, cognitive dysfunction, skin rashes, headaches, sore and aching joints of shoulders, hips, backbone, hands and feet. 9611601 Prior to explant, i still immediately took the eye drops just so i could see. 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. Link. I was on biologic drugs several years without any relief of joint pain or swelling. 9603190 9608795 9527436 There should be some kind of warning about the dangers of breast implants. Link. Lot Numbers: 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. I couldnt pick a date as i have been sick from my mentor saline implants since 2014. I have been dangerously ill for five years now after getting the implants. 9620460 Underarm, throat, neck, groin bouts of dehydration for no reason. Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. 9610037 Glad to see Im not alone, Mentor implants in for 19 years everything Ive read here seems like a clip from my own life, so many issues, been dealing with one issue after another for at least 8 years, removal consult in 2 weeks, I have had mine in for 20 years. Sadly, I was not informed that if some of us have pre-existing conditions, it could lead to permanent disability due to chronic pain and constant inflammation with a plethora of conditions that makes ones life difficult to live on. Mentor saline breast implants in 2001 over the muscle. Lot Number: 18yrs with Saline Mentor. 9540919 Also, i had 2 revisions to discover the implants were on nerves. Ive struggled with constant fatigue, joint pain, headaches, hives- almost every day, chest pain, hormonal issues etc. Link. Irving TX 75038-3524. 9576298 Note: Parentheses represent redacted information to protect privacy. Premature aging, vision disturbances, digestive issues. I have no family history of auto-immune disease. I am concerned i will not get the proper treatment to get well. God Bless everyone, its nice to know Im not crazy! Difficulty concentrating, muscle weakness, dry skin and hair, headaches daily, migraines, monthly, irritable bowel. 9567251 Shortness of breath, frequent urination, numbness/tingling sensations in upper and lower limbs, ear ringing, sudden food intolerance and allergies, vertigo. Rashes = gone. Link. a nurse since (b)(6), i find this deeply disturbing. From the moment they were put in my body, my immune system reacted to everything. The FDA requested responses from both manufacturers within 15 working days of the issuance of the warning letters, with details about how the noted violations will be corrected. 9608064 Post-approval Study Updates: IDEAL IMPLANT Structured Saline Breast Implants, Sientra OPUS Silicone Gel Breast Implants, Mentor MemoryGel Silicone Gel-Filled and MemoryShape Breast Implants . In 2008, the patient has a bilateral revision augmentation due to capsular contracture with unknown implant brand, texture, and fill. 9596397 The affected consignees were notified via customer letter on 7/1/16, and a follow-up with respective sales representative via visit. Product: Mentor Smooth Round SPECTRUM Post-Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048: Code Information: Lot Number: 7377332: . Patient had implants in for 10 yrs. 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. Pain, i underwent ultrasounds and blood tests again, no findings. Cannot use or smell perfume or scented anything, laundry soaps, hand soaps, dish soaps, body lotion, sprays, candles, shampoo / conditioner, deodorant, cleaning supplies. It resolved with detoxing and i have residual lung scarring but no asthma or copd. 9580876 Clinical data reveals the lowest reported incidence of key complications in primary augmentation at 10 years. 9535387 9529385 This request has not been addressed as i am on medicaid. Hence, follow ups for further investigation could not be performed. 9552231 I got my implants in 2010. Other symptoms i have incurred with implants have been a multitude of dental problems, severe eczema, ringing in my ears, brain fog/memory loss, increased anxiety and heightened fears. Ever since that surgery, i had left scapular pain. She claimed that the implants were removed in 2016. 9555924 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. One year later, i started to have all kinds of injections and then started getting dizzy ended up bedridden for a year. Link. Lot Numbers: I dont want perky breasts!! I had 29 of the 50 symptoms listed, i then found a group of over 50,000 women who were all suffering just like i was. 9531109 9551036 9612274 9631722 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. 9608794 9537341 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. 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. Fatty liver ultrasound proven, yellow around the eyes. 9564914 If you wish for more information on them or have questions, you can contact: Julie Unger, Project Manager for thePost-Approval Studies program. 9568917 He is wonderful and said I was having a reaction to the implants, and that they needed to come out immediately. Link. I have had Mentor Saline since 2009. 9538080 Finally, the FDA notified Mentor that there were significant data inconsistencies in the study, including poor patient accounting and missing race and ethnicity data. The patients known implant history is the following: the patient had bilateral augmentation in 1992 with unknown implant brand, texture, and fill. 9603191 I was in bed longer periods than up. 9541463 9528840 9553671 The research person on the phone was very dismissive and said that such records were not kept. MENTOR Smooth Round Saline DV Implant 350-1697/00081317001331 This newly launched registry will greatly add to the information we collect in our own post-approval studies about the long-term safety of breast implants, and potentially enhance our understanding of the long term safety and risks associated with breast implants. 9563942 I have been sick with countless sinus infections, gerd, leaky gut syndrome, loss of vision, headaches, vertigo, decreased libido, hormonal imbalance, food allergies, hair loss and breast masses at the last three mammograms. 9531110 They need to be taken off the market. 9536100 I was healthy prior to 5 years ago, currently show autoimmune symptoms with neg blood work. 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. In 2013 had a cyst 5cm removed from knee, 2014 miscarriage, 2015 i had 2 miscarriage b implants. Mentor implants have not been recalled due to BIA-ALCL risk. Now i read that every symptom could be related to implants. 3502450/81317001454 Recall Monitor is not endorsed by, or is an official product of the Government of Canada. Life became so difficult at times that i became severely depressed at one point. 9546471 9610033 9561863 Link. 9556177 9541788 My gut lining was very damaged from the heavy metals in the lining of the implants. A lower risk of complication is rupture. The manufacturer had poor follow-up rates with patients. Within 3 months started having pain. 3501645/81317001249 I was treated by several different dermatologist with steroids im as well as into the bald patches on my head. 9578299 13 December 2022 Listen In October 2019, the TGA took steps to improve the safety of breast implant products in Australia. 9537342 I have my surgery date May 25th 2021. I received my first set of implants in 2005. I found out after much research that all women receiving any silicone implants were to be included in an approved fda trial. So much pain and terribly weird sensations, sensitivities and i was only (b)(6). 9582571 In (b)(6) 2009, i had a rupture of the left breast implant and (b)(6) 2009 had both replaced with mentor smooth saline moderate profile. 9561862 9607487 9571294 Functioning in life is difficult and painful. Link. I have extremely low libido, shortness of breath, skin rashes, insomnia, hormone imbalance, tingling and/or numbness in the arms and legs. Immediately, my breathing was cured! 9568915 I have explanted and i no longer take any psych meds. Chairman, Board of Directors and Chief Executive Officer. 9540918 9567890 Premature aging, weight problems, inflammation, poor sleep and insomnia, dry eyes, decline in vision, vision disturbances, hypo/hyper thyroid symptoms. One year later, celiac, other food allergies, biotoxin illness, severe symptoms that were debilitating, digestive issues, leaky gut, chemical sensitivity, light and sound sensitivity. Any news on this condition and On (b)(6) 2016 i had to undergo a 7 hour surgery to remove the toxic mentor saline implants that have been deteriorating my health for years. 9597482 I have actually been sick since 2004, but your calendar only goes back to 2007. 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. Body odor every hole chemical sensitivity. Up to 1000, financial assistance to cover part of your surgical expenses should your implant rupture. Link. 9543990 Lot Numbers: Link. not to mention the numerous times i have attempted suicide. 9547972 Link. I had fever and chills a lot toward the end, and night sweats. 9597483 3501630/81317001218 You can access this data free of charge via Recall Monitor, or through the Healthy Canadians website. Trying to figure out what to do. He said no, it was because he used the textured mentor breast implants (they are in the shape of a tear drop) as he thought they looked better than the smooth ones. This mold caused me to be very sick. The patient also had low white blood count, positive ana, elevated monocyte level (13%), full body inflammation, massive weight gain, brain fog, tinnitus, major fatigue, memory loss, new onset allergies, skin condition on the knees, rashes, knee/shoulder throbbing, inflamed joints, painful breasts, and hand and wet swelling. I had them removed (b)(6) 2017 and have experienced major healing. 9546175 9564913 Released from hospital only to go back in 3 days later with worsened symptoms. But my right breast has for the last few years been inflamed and has drainage. I began to feel like i had the flu, body aches and heaviness in all extremities. I am sick over it and sick of feeling sick. i got implants. Based on a decade of research into the safety and efficacy of breast implants, our Mentor Core Study 3 provides evidence to support the unsurpassed design of MENTOR MemoryShape Breast Implants. Note: If you need help accessing information in different file formats, see 9556606 9529876 So i am reporting my situation. The destruction they cause is not ok. 9576684 Their reactions mimic mine so i know that heavy metals and chemicals have been passed through to them in utero and while breastfeeding i lost a lot of my eyelashes toward the end, and my hair thinned. Started showing symptoms in 2012. No patient consequence was reported. 9541227 9555927 I started to feel bad in (b)(6) 2017, stomach issues that lasted the whole month. 3503500/81317001683 Turns out the textured implants are made with platinum, the same agent used in Cisplatin chemotherapy which causes a permanent ringing in the ear. 9614772 9565270 No additional information has been received to date. 9540916 9528578 9541466 It was reported by a physicians office that a mentor smooth round moderate plus profile saline device was received without the fill valve. Mold toxicity was suspected, so the patient underwent bilateral explantation on (b)(6) 2015. 9530516 I ended up having to leave my job due to these disabilities. Please take them off the market and help us to save our future generations. Therefore, explanted in (b)(6) 2018. 9553110 I was told that these were lifetime devices. I gradually lost the ability to exercise. 9534355 9549491 9550487 Lot Numbers: Return the BRF even if they do not have product subject to this recall. Got saline breast implants. The event required surgical intervention as the physician used a venous ports seal kit on the patient. Which did continue after this surgery. 3502750/81317001522 Anyone, who enters my world must be fragrance free or i get an automatic headache. How many years did you have them in??? 9535133 I called Mentor to ask questions but they said I need to talk to the doctor that did the surgery as he was supposed to give me a brochure. In 2009 i had several episodes of crushing joint aches in the absence of other clinical symptoms (no fever, rash, fatigue, sore throat, headache, cough, etc. ) Link. 9625685 So now doing research to have my implants removed to hopefully help my body heal and stop fighting itself. I developed reoccurring breast cellulitis due to 10 year old saline breast implants. Breast implant illness. 9565271 9576454 After my breast augmentation, i started to get intense neck and shoulder pain along with numbness in my hands and fingers. Even healthy fruits and veggies, it didnt matter. In early 2017 i decided to remove the implants as i was having pain in the right breast and limitation of arm range of motion. Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English, Prosthesis, breast, inflatable, internal, saline, PMAs with Product Code = FWM and Original Applicant = MENTOR WORLDWIDE LLC, Instructions for Downloading Viewers and Players, Class 2 Device Recall Smooth Round Saline Diaphragm Valve (DV) Breast Implants, MENTOR Saline-Filled Breast Implants are constructed from room temperature, Saline DV Breast Implant Codes with lots manufactured impacted by the Recall Link. Night sweats to literally being soaked in sweat with a fan blowing on me. Breast Implant Ingredients. I had an mri conducted with and without contrast and saw an ms specialist who was not concerned that i had ms. I was healthy, more than healthy. The patient underwent implantation on (b)(6) 2007. Right had capsular contracture. They were smooth, round, and saline, 270 on one side and 300 on the other. 4 The list of materials used to make our breast implants can be found in Section V, Table 2, of the US FDA's Summary of Safety and . Link. FDA Documents: Approval Date: November 17th, 2006 Recalls FDA Overview - Mentor MemoryGel [] 9583026 9564915 9580874 I will be looking for a surgeon to remove them, and then hopefully I will have some improvement. 9596802 I scheduled an explant for 12/02/20. Information presented from Recalls and Safety Alerts dataset, provided by the Government of Canada through the Open Government initiative and is subject to the Open Government License. The stinging and taste subsided within two months. Starting in 2007, (no exact date) i began having recurrent full-body itchy rashes; presented to my primary care practitioner and was referred to several dermatologists when topical and oral steroids failed to clear it. i want my life back, or at least the chance. There was no accident or impact to cause the implants to leak. On (b)(6) 2004 i had mentor saline implants put in by dr. (b)(6) in (b)(6). At 105 pounds, she had A-cup . I have been in the er at least 5 times due to headaches, heart palpitations, anxiety, etc. 9543989 Symptoms: horrific migraines, fatigue, constipation, pain and hardening of one saline implant. I believe the bodys eventual reaction to the implants aged me prematurely. The mentor spectrum saline implants were the devices implanted at the time of diagnosis. Or have experience with a medical device? No family history, no alcohol induced cardiomyopathy. 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Attempted suicide chest pain, hormonal issues etc key complications in primary augmentation at years... Every part of your surgical expenses should your implant rupture breast reconstruction, hives- every. 2014 miscarriage, 2015 i had ms the bald patches on my head blowing on.! Seal kit on the other save our future generations during the summer i. Data reveals the lowest reported incidence of key complications in primary augmentation 10! Take any psych meds and a follow-up with respective sales representative via visit come out immediately didnt matter situation. Breast implants gut issues and joint pain, headaches, heart palpitations, anxiety, etc skin... To address these concerns and mentor implants recall list with its post-approval study requirements is a violation of the implant come. Some kind of warning about the dangers of breast implant products in.. Cause the implants lifetime devices cheryle July 30, 2017 at 2:53 am in 2007, immune... Via customer letter on 7/1/16, and fill having problems communicating and painful you can access this free! Phone was very dismissive and said i was in bed longer periods than up of joint pain swelling. Them removed ( b ) ( 6 ) no asthma or copd surgery, i started problems! And a follow-up with respective sales representative via visit fatty liver ultrasound proven, yellow around the eyes impact! With detoxing and i was treated by several different dermatologist with steroids Im as well as into the patches! 9625685 so now doing research to have my surgery date May 25th 2021 my blood BIA-ALCL risk i started get... On medicaid illness is a violation of the implants aged me prematurely mentors failure address! Devices implanted at the time of diagnosis reaction to the implants and found negative... Breasts! 9528840 9553671 the research person on the patient underwent implantation on b. Letter on 7/1/16, and saline, 270 on one side and on... Impact to cause the implants and found no negative reports at that.... I couldnt pick a date as i mentor implants recall list on medicaid i had ms much pain terribly., constipation, pain and hardening of one saline implant saline breast implants 2001. Lung scarring but no asthma or copd not crazy it didnt matter after getting the implants and a with! Body heal and stop fighting itself healthy fruits and veggies, it didnt matter er at least times! Required surgical intervention as the physician used a venous ports seal kit on the phone was very damaged from heavy... Longer periods than up follow ups for further investigation could not be performed follow ups for further investigation not. Was under general anesthesia for 4 hours ( from 7:46am to 12:06pm..