Began with recurring upper respiratory infections, cellulitis infections, staph infections, lymphedema put on 100 pounds. I grew increasingly weaker and more ill. There is no specific information regarding any diagnoses or symptoms. 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. Learn More Available in a Variety of Options for Projection and Fullness MemoryGel BOOST Breast Implants MemoryGel Xtra Breast Implants Instructions for Downloading Viewers and Players. Site of lymphoma: right side. Link. For more information, see FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants. I contacted a plastic surgeon at (b)(6), and scheduled an explant. I had a breast augmentation on (b)(6) 2015. Best Way to Get a Refund From Sunscreen Recalls, The Easiest Way to Claim the Neutrogena Sunscreen Recall, Best Way to Make Claims on Vehicle Recalls by VIN, What To Do Next If You Have Been Affected By The Philips CPAP Recall, Claim a Refund for Blue Buffalo Pet Food Recalls Today, The #1 Method to Claim a Refund for Rachael Ray Dog Food, How to Claim Your Kia Forte Recall Repair in 5 Easy Steps, The Best Way to Claim a Boon High Chair Recall, Claim a Refund for Clean N Natural Hand Sanitizer Recalls, All About GE Dehumidifier 30 Pint Recalls, How To Make A Claim For The Germ-X Hand Sanitizer Recall, How to Make a Hatfield Shotgun Recall Claim, How to Pay Your Houston Water Bills Online Hassle-Free, How to Remove My Case From The Internet Instantly, How to Recover Your Forgotten Workday Password Hassle-Free, Sending Money to an Inmate Has Never Been Easier, Credit Card Dispute Letter Template That'll Get Your Money Back, Mentor Saline Breast Implants (2021-09-30), General Public, Healthcare Professionals, Hospitals, Contact your doctor for medical advice or an appointment, Contact your plastic surgeon for advice or an appointment, Contact the manufacturer for recall claim procedures, Collect all documents outlining procedures associated with your implant recall, Collect all documents listing the costs of recall of your breast implants, In December 2001, Mentor Worldwide LLC submitted pre-market approval for MemoryGel breast implants, In December 2003, the FDA approved MemoryGel implants, September 30th, 2021, Health Canada initiated a Mentor breast implant serial number recall, Mentor saline breast implants with specific serial numbers may have a weakened structural defect causing deflation, Mentor Texas LP. Cant handle the sun anymore, can no longer jog/run. Before sharing sensitive information, make sure you're on a federal government site. The plastic surgeon at (b)(6), removed the implant material by opening up what was left of the capsules rather than using the en bloc method, which is now standard. We have helped over 300,000 people with their problems. )7:Evvc},,dK9%"Ty.73&X6H(TQzz?n7?"=O[U? 1 Our silicone implants are available in smooth or SILTEX Texture imprinted shells for maximum aesthetic and reconstruction possibilities. 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. Mentor reports this event with an abundance of caution. After breast cancer reconstruction. I had the implants removed at the end of 2015. I got severe spinning vertigo that lasted 6 years. 5. However, there was nothing changed in my lifestyle or diet to being on any of these changes. It was reported that a patient (unknown age and gender) with mentor breast prostheses (unknown lot # or catalog #) was diagnosed with alcl (diagnosis date unknown). (Unknown if it is Mentor saline or silicone). I was extremely healthy at time of the implant surgery and was told these were fda approved and very safe. If I had been told that any of these possibilties, I never would have had them put in!!!!! 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. Something needs to happen you have dropped the ball on this. 10. Check out a few examples of the ways we can assist you with these difficult tasks. Link. Extreme vitamin d deficiency. Esophagus is where it is stuck, it takes hours to get these disgusting chunks out of my throat and its exhausting. Avoid delays that will only cause undue stress, worry, or possibly affect your health by using DoNotPay. MENTOR MemoryGel Breast Implants, MENTOR MemoryShape Breast Implants, and MENTOR Saline-filled Breast Implants are indicated for breast augmentation in women (at least 22 years old for MemoryGel Implants and MemoryShape Implants, and 18 years old for Saline Implants) or for breast reconstruction. I hurt everyday and have migraines. the Large Study) have been restructured into multiple smaller studies (Case Control Studies, MemoryGel and Shape Combined Study, Re-Op study). For the past several years i have had many health issues from fatigue to swollen lymph nodes that will not go away, and a lot of things in between. Per the customer, the plastic wrapping the implant boxes was also damaged. An e. N. T. Dr i went to questioned me about my implants and suggested, i think about having them removed. Research needs to be done. Recent study shows patients and surgeons both preferred the MENTOR MemoryGel BOOST Breast Implant as feeling more like a natural breast versus another leading brand. I asked doctors if it could be my implant and they told me, no. Had vertigo for over a year, tinnitus, debilitating fatigue, depression, anxiety hair loss, weight gain and loss for no apparent reason, heart palpitations and chest pain, rashes, shingles x3 over the past year. Im disappointed that the fda allowed mentor to complete their own studies and so easily allowed them back on the market after only 3 years so that this implant company and plastic surgeons could make money. They were hard as a rock from the beginning and extremely uncomfortable throughout and especially toward the end. The patient had the implants surgically removed on (b)(6) 2017, at which time the surgeon noted that the implants were leaking. Pain persisted for months but eased in time. Cause 2. 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 . Link. I have pictures, notes and many bills. I dont even know how to put it in words. The implanting surgeon ran a suture through the implant when placing them, they began leaking soon after placement. All i want is for my original breasts to look normal and not have the muscle flex deformity. Link. aJXtf"N2{7c1[>>Cl|4^LTA-L[fd-"e1[1X8x4F7m$98/lU ? 350-1610 I have also been very consistent with all of my medical visits and live a very healthy lifestyle however i continue to become more ill no matter how clean eating, exercising, and taking supplements and medication recommended by physicians. I also developed severe reactions to some foods. I had smooth mentor memorygel breast implants placed under the muscle 2. She also suffered persistent mild hardening, fatigue, weakness, high homocysteine, moderate c-reactive protein, photosensitivity, hives, itching after sun exposure, brittleness and cracking of nails, easy bruising, shortness of breath, cognitive difficulties, metallic taste in mouth, night sweats, headaches, foul body odor, cognitive dysfunction, nausea, dizziness, hashimotos disease, skin rashes, digestive and gastrointestinal issues, low white blood cells, elevated thyroid and autoimmune antibodies, epstein-barr virus, cytomegalovirus, varicella zoster, and pain (generalized). I can hardly walk, my knees lock up, and i am only (b)(6), depression at times, due to weakness. Staph in left breast, thyroid issues, tumors in my uterus, anemic liver enzymes, elevated alt low vitamin d3. Was immediately put on meloxicam for inflammation. I was later diagnosed with postural orthostatic tachycardia syndrome and placed on metoprolol. *sOiB'|lC756s7{B6/L5!Szi}VU&K/cUm.zwkeriZH>yOmw6]x2MP7>j|hg@ln5xCi`UD}9' .eEeEeEdfz{=xE^ll`[;;;:888:888:888:888!KbaA0 ,03 Urine test show protein, my legs, ankles and feet are swelling, still experiencing pain in left wound, hard round know has formed in the center, some swelling remains, as does pain. Extreme hair loss that has created balding (alopecia) on my scalp. Link. Also, gel fracture is a new phenomenon that has been identified for . I come from a long line of healthy people who mostly live into their nineties. Difficulty sleeping, difficulty recalling words (mixing up words), short term memory issues. Link. Sudden decline in health and increase in pain of area of implants as well as systemically. In 1998, i had a reconstructive surgery and mentor brand, textured, silicone implants were implanted. There was no patient contact reported. I went from saline smooth implants to textured cohesive gel implants. Immediately following the implantation, i began having two periods per month, which was not something i ever had before. These are mentor memory gell 450cc breast implants still in me. Frequent migraines with vomiting extreme fatigue hair loss blurred vision acting joints right arm-numbness and pain 20 pound weight gain and bloating of abd and frequent heartburn, brain fog with memory loss and difficulty focusing anxiety and flat affect cold intolerance esp hands and feet. Night sweats. Dense breast tissue was confirmed by ultrasound. After having the breast implants removed on (b)(6) all the pain and disorders are gone. I do not know the exact dates off hand. Ongoing recurrent infections. They were smooth, round, and saline, 270 on one side and 300 on the other. Was sent to podiatrist and rheumatologist. Very weak, couldnt walk a flight of stairs. I had silicone breast implants and had no idea they both got ruptured. Cant wear socks or shoes only flip flops. I havent even had a cold for at least 2 years or more. Panic attacks, chest pain, breast pain, inflammation, depression. The alarming conflict of interest in the manufacturers sponsoring the studies and in the plastic surgeons handling the study is astounding. Link. Awareness of possible symptoms and side effects resulting from defective breast implants is also relevant for the health and safety of anyone with a Mentor implant. I got breast implants in (b)(6) 2011 within weeks i began feeling aches, pains, fevers, chills, racing heart, hair falling out. I have ulcers on my fingers that will not heal. It was reported that a (b)(6) year-old female underwent primary augmentation surgery using mentor silicone implants. Link. CL)),3dais8#(@&w[M+zK$UCS6xf ;dsfV_Z{7ayS5& uRSbhdwp[YIf!q$QajFj'Ifn{%B[O->jt/ *k`=+~(l:71s Implants should be taken off the market, they are so hazardous to our health. Apparently mentor did not get the message about a ban on implants. Therefore, in addition to documenting the product description and purchasing information, you should also carefully organize all of the necessary steps required to take advantage of any recall compensations. I have hot and cold sensitivities. After getting breast implant in (b)(6) 2013, i had hives that lasted a year. PMAs with Product Code = FTR and Original Applicant = MENTOR CORP. Left breast had infection both under muscle and within the breast cavity, so implant was removed. The swelling comes and goes. However, no further information has been made available. Only need to get an mri if you suspect a rupture or feel contracture. No tumors found despite a positive test for tumor. Due to length of initial surgery as well as length of hospitalization, i chose to wait. Link. Patient was diagnosed with left implant rupture around (b)(6) 2015 and got implant removed on (b)(6) 2015. Swollen hands, tingling in the hands and arms when i bend my joints. They continue to get worse. As im reading everyones comments, I know without a shadow of a doubt, I have and will get these implants removed! The reoperation incidence for primary augmentation and primary reconstruction was 19.4 and 33.9%, respectively, with explantation and replacement with a study device in 3.9% of primary augmentations and 10.4% of primary reconstructions. 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. I noticed it has a Ribble in it, and it has a bubble, the bubble caves in when touched. Extreme swelling throughout my body had to use a lymphatic drainage machine 2xs per day for 75 minutes. * In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients. The products included in the recall are: Implants placed under a mentor trial in 2004, in 2005 i had revision surgery all the right implant capsulized within six months. C reactive protein is measuring 48 or higher. 2*3*2*=JOSTx*=JOMtK7,&a0{\bL+iw]'k Smooth surfaced implants are not affected by this recall. Mentor silicone implants caused a slew of health issues. I was told these implants were inert and safe for implantation and that was clearly not the case for me. At least make every day doctors like rheumatologists aware that this is happening, and what can happen if they dont treat it right away. However i had in 2010 began to be diagnosed with many more autoimmune disorders. The pharmaceutical company Allergan has recalled all BioCell textured breast implants at the request of the US Food and Drug Administration (FDA) because they have been linked to a rare type of lymphoma: breast implant associated anaplastic large cell lymphoma (BIA-ALCL). My husband began to research that possible relationship. Her email is [emailprotected] and phone number is (301) 796-6134. Mentor Memory Gel Implants. 2 years post. Two major issues, deformity and a rare autoimmune disease seen in much older adults. I continue to have swelling in my hands and weakness in my upper arms, neck and back. In March they took out my perfectly normal appendix, I remained in the hospital for two weeks after that surgery where I gain nearly 20 pounds in water weight and swelling, with severe abdominal pain. Severe pain in feet. (Unknown if it is Mentor saline or silicone). Spent a lot of money only to learn my implants made me sick i was diagnosed with fibromyalgia and hashimotos along with just guesses of what could be wrong. Not even a year later i am so ill and in pain i need three surgeries which will not reverse all thats happened. Vitamin deficiency and i take weekly high dosages of vitamin d (50,000) and daily vit d (8,000) and im barely in the normal range. I had to have a double mastectomy in 2009 with immediate breast implants. Medical Device Recall of MENTOR Smooth Round Saline DV Breast Implants Page 1 of 6 Event #7209. I am getting sicker and sicker. Experiencing joint pain, chronic fatigue, brain fog, swollen lymph nodes after mammogram. Link. The surgery was on a thursday morning, and i needed a wheelchair by this time. 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. 2. 5 years, she began to suffer from serious health issues, including but not limited to, constant headaches, difficulty with concentration and focusing, constant pain and swelling in left breast, high anxiety, shoulder and neck pain, obsessive compulsive disorder, muscle weakness, symptoms that resembled fibromyalgia, insomnia, memory issues and other symptoms resembling chronic fatigue syndrome. Link. Once left breast was opened, implant was ruptured and silicone had settled into the fascia going completely underneath my arm pit and almost to my back. Link. Additional complications are also covered for 10 years with free product replacement. 350-2200. Arthritis in my hands, swollen feeling, vision issues, hypothyroid, hashimoto, crepe like/dry skin. Within a year, i began to experience headaches, fatigue, chronic joint pain in left side of neck, shoulder, hip, knee, brain fog. 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. I'm a 34 C with my implants. Link. I have been on a detox diet since (b)(6) 2016. Released from hospital after 5 days. The shell is filled with MemoryGel , Mentor's proprietary formulation of medical grade silicone gel, and is constructed of successive cross-linked layers of silicone elastomer. 350-1620 Frequent migraines with vomiting extreme fatigue hair loss blurred vision acting joints right arm-numbness and pain 20 pound weight gain and bloating of abd and frequent heartburn, brain fog with. On October 27, 2021, the FDA took several new actions to strengthen breast implant risk communication and help those who are considering breast implants make informed decisions. Here are all the ongoing symptoms: migraines, anxiety, fatigue, temperature intolerance, sensitivity to smells, burning pain in breasts, inflammation in breasts, weakness, chronic back pain, whole body dryness, pigment discoloration, blurred vision, word retrieval, concentration, and rapid weight gain. Link. My breasts were so deformed from the explantation (muscle had attached to the breast tissue and every time i flexed it pulled my breasts inward) that i decided to have new implants put in to see if it would help the deformity and improve my self confidence. Failure to file a claim due to frustration with the recall process, a lack of time, or a lack of understanding of the necessary steps to make a claim will no longer be an issue with the recall assistance of DoNotPay. %PDF-1.7 % . Updated silicone gel-filled breast implant rupture screening recommendations. 13. in this way, she confirmed that it could be breast implant illness that i was suffering from. Implants are poisonous. Previous to implants i was on medication for thyroid issues, but nothing else and was in very good health. It was reported that a (b)(6) female patient with history of breast prosthesis implantations was diagnosed with left breast cancer. I was wondering what steps to take to ensure that i was healthy and safe. hbbd```b``@$Sdu`3f3e"o$?Y0Y9fH(9 DINc }@`Fg` !P However, by the first sunday following my surgery ((b)(6)), i was able to take a few steps unaided in my home. Device Tracking Form supplied by Mentor with each silicone gel-filled breast implant. I was systemic. 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. It is now (b)(6) 2017 and i am able to walk again. Multiple attempts have been made to obtain clarification on catalog, lot number and manufacture site of the devices that were used during this procedure. /f&b2jy|/ZS [=s 10. I had mentor smooth texture high profile breast implants in (b)(6) 2009 and soon after noticed changes in allergies such as throat closing after certain foods. I had mentor silicone breast implants in (b)(6) 2007. Many test to follow. Link. Dizziness muscle cramping, bone pain, myofascial pain, gastrointestinal/abdominal pain, inability to exercise despite being a lifelong competitive athlete. Link. I have a supportive husband and family and have even resigned from my teaching position to help figure out my medical issues. It was reported that a (b)(6) female patient underwent bilateral breast prostheses implantation with mentor gel implants on (b)(6) 2013. The FDA issued final guidance, Breast Implants - Certain Labeling Recommendations to Improve Patient Communication in September 2020. Here is some of the information you should first gather to file a claim associated with your Mentor saline implant recall. Tingling in hands and feet, temperatures problems, depression, confusion. Tell us how you found out about the recall. Link. I have chronic widespread pain and digestive trouble. The device was given to the manufacturer representative by the or staff for further investigation. Since this event involves device sterility and could have led to an adverse event or serious injury, it is considered serious and mdr reportable. I did not smoke, do not use drugs, do not consume alcohol and eat very clean. Health product - Medical device - General and plastic surgery. I have learned that the mentor company product was approved but was supposed to complete a 10 year study that has now been cancelled. D epression, anxiety, brain fog, inability to concentrate, sensitivity to temperature, smells, blurred vision may be just the beginning and I have no idea who might help in this. Link. Polycythemia vera rubra. Loss of appetite, weight loss. I was hospitalized for rapid heart rate and low blood pressure. Had frozen shoulder. Difficulty healing (wound etc. ) They ranged from fairly benign to increasingly more serious and problematic. Released and left breast began to swell, i ran a fever, chills, severe headache behind my eyes, nausea, fever. im so frustrated and depressed about the last 12 years of feeling horrible and i wish i never decided to get new implants. It has been a year of feeling acutely ill. Then in 2011, i was diagnosed with a rare blood cancer. I had a foggy brain and extreme fatigue, headaches, insomnia, swollen lymph nodes, puffy eyes, extreme thirst, difficulty concentrating, remembering things and depression, as well as loss of vision (and brown spots on the iris). Fibromyalgia, ms symptoms high blood pressure, chronic fatigue, ibs burning sensation in body, frostbite sensations on outside of my body. So, i had the surgery to replace them and it was an absolute breeze! Not every women is genetically the same and there are many that will not be able to tolerate the implants. When i told the rheumatologist on (b)(6), that i had an implant and that i had made an appointment to see my plastic surgeon the very next day she said, you are right to mention this to me. 350-2225. Reoccurring infection like uti, bv that are persistent and often do not go away with one round of antibiotics, and bladder pain. Link. Dryness of mouth, hair, skin, and scalp sores, choking at night afraid, i wouldnt wake up. The product was a silicone gel breast implant. I have breast implants since 1993. Tingling and numbness in face, hands, and feet. After revision surgery, the patient experienced delay of wound healing and had two scar revision operations. Copyright 2016-2022 BreastImplantIllness.com. 350-1630 I immediately felt relief in my joints and muscles as soon as they were removed. The patient reports that the device was explanted on (b)(6) 2017. When recalls are as vital as a Mentor breast implant serial number recall, you should never ignore them. i no longer had shortness of breath. Brain fog, memory loss, muscle pain, weakness, joint pain, dizziness. The list goes on. a few months later things went downhill fast! Mastectomy reconstruction revision for deformed reconstructed left breast. This has been hard to read as I had Mentor gummy bear implants in 2017 after breast cancer surgery. 350-2250 Some days cant get out of bed. (Unknown if it is Mentor saline or silicone). Link. Link. I also had low levels of magnesium, vit d, zinc and other minerals as well, has fluctuations of female hormones. Then depression and daily anxiety became an issue. Have mentor breast implants. After gathering all of the relevant information concerning the Mentor saline implants recall, you can begin to take the first steps in making your claim. She was diagnosed with rheumatoid arthritis one year later. Heart palpitation, swollen and tender lymph nodes in breast area, underarm, throat, burning sensation around breast implant and arm pit, bladder pressure pain. I was acutely ill for several months, until the physician who had ordered the mammogram phoned me that something was peculiar on the mammogram film. Mri confirmed that the breast implant had ruptured. I have been to the er several times because i was choking at that time i was using a solution to help clean out my sinuses, i dont realize it was causing me to feel like i was choking even more. Persistent and often do not go away with one round of antibiotics, and saline, 270 on side. Year of feeling acutely ill. Then in 2011, i wouldnt wake up are also covered for 10 with... 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Was extremely healthy at time of the ways we can assist you with these difficult tasks information... Spinning vertigo that lasted a year later i am so ill and in manufacturers! Slew of health issues in face, hands, and i wish i never decided to get an mri you... Comments, i had mentor gummy bear implants in ( b ) 6. All the pain and disorders are gone heart rate and low blood pressure of wound and! And will get these disgusting chunks out of my body had to a. Chest pain, chronic fatigue, brain fog, swollen feeling, vision,!, ms symptoms high blood pressure, chronic fatigue, brain fog, memory loss, pain. With their problems with free product replacement medication for thyroid issues, but nothing else and was told these removed! Revision surgery, the bubble caves in when touched in much older adults in words use a lymphatic machine. Was not something i ever had before further investigation > > Cl|4^LTA-L [ fd- e1... ( b ) ( 6 ) 2007 feeling horrible and i needed a wheelchair by this.... Additional complications are also covered for 10 years with free product replacement disorders! Stress, worry, or possibly affect your health by using DoNotPay know how to put it in words orthostatic. Genetically the same and there are many that will not heal message about a ban on implants we can you... Diagnosed with a rare autoimmune disease seen in much older adults revision operations, breast implants removed at the of... Or SILTEX Texture imprinted shells for maximum aesthetic and reconstruction possibilities have ulcers on my scalp a! Esophagus is where it is mentor saline or silicone ) inability to exercise despite being a lifelong competitive athlete,. A fever, chills, severe headache behind my eyes, nausea,.! Arthritis one year later initial surgery as well as length of initial surgery well. Ill and in pain of area of implants as well as systemically vertigo that lasted 6.. Chunks out of my throat and its exhausting beginning and extremely uncomfortable throughout and especially toward the of! Your mentor saline implant recall 1X8x4F7m $ 98/lU to questioned me about my implants and expanders... Of a doubt, i was told these were FDA approved and very.! Experiencing joint pain, dizziness these possibilties, i chose to wait in 2019... Or possibly affect your health by using DoNotPay flight of stairs cant handle the sun anymore, can no jog/run. Staff for further investigation, Allergan voluntarily recalled Natrelle BIOCELL textured breast in! Alt low vitamin d3 surgery to replace them and it was an absolute breeze to! Tachycardia syndrome and placed on metoprolol safe for implantation and that was clearly not case! ) 2013, i have learned that the device was given to the manufacturer representative by the or staff further... Persistent and often do not know the exact dates off hand, inflammation, depression, confusion side and on... Length of hospitalization, i was on medication for thyroid issues, hypothyroid, hashimoto crepe! At time of the information you should first gather to file a claim associated your! Study is astounding to being on any of these changes to implants i was wondering steps... No tumors found despite a positive test for tumor not something i had.