9589652 Customer Service. 9611603 Had my surgery in (b)(6). One year later, celiac, other food allergies, biotoxin illness, severe symptoms that were debilitating, digestive issues, leaky gut, chemical sensitivity, light and sound sensitivity. One year later, i started to have all kinds of injections and then started getting dizzy ended up bedridden for a year. For Additional Information Contact. My card states Smooth Round High Profile Gel. An explant surgery on (b)(6) 2017, left was leaking and partially deflated. Joint pain, lethargic, slow to heal, sensitive to heat, cold extremities. 300NACL. But do you really suppose that 18,000 plus women are all experiencing a placebo effect with amelioration of their symptoms?. 9630358 9579266 In 2011 at the age of (b)(6) i had a breast augmentation using mentor 3500cc smooth saline implants. Woke up systemically ill and in widespread body pain. 9555186 Blood tests for sjogrens disease, came back negative, due to my dry mouth. Right had capsular contracture. They need to be taken off the market. 3503250/81317001607 Link. Always cite the International Consortium of Investigative Journalists when using this data. 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. 3502700/81317001515 After approx 7 yrs i started having problems communicating. Premature aging, weight problems, inflammation, poor sleep and insomnia, dry eyes, decline in vision, vision disturbances, hypo/hyper thyroid symptoms. Link. (b)(6) rn, bsn, ccrn, bs. 9610037 He was able to locate me by my name and dob, locating my implants and told me to find a surgeon and they would send his replacement implants. I have become very clumsy, falling often, due to dizziness when i least expect it. 9589651 This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them. 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. 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. 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). 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. 9594634 3502500/81317001478 9553110 9579267 Link. Rashes = gone. Pain around the chest wall and breasts, muscle twitching, dehydration, chronic neck and back pain. 9543357 Link. 9555926 At 105 pounds, she had A-cup . Lot Numbers: 9580873 Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and fax/email to Sedgwick at 888-912-7086 or mentor7209@sedgwick.com within 3 business days. I am not sure whether I have saline or silicone. Per the customer, the implant did not come into contact with any patient. Patient was under general anesthesia for 4 hours (from 7:46am to 12:06pm). 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. Absolutely no auto immune issues in my blood relatives. 9586784 9582182 In 2013 had a cyst 5cm removed from knee, 2014 miscarriage, 2015 i had 2 miscarriage b implants. Approx. 9563942 9611046 Fatty liver ultrasound proven, yellow around the eyes. Now i see it because i was part of these studies and not f/u with. 9550674 Safety data such as reoperations, deflation, capsular contracture, and pain will be collected annually out to 10 years for each patient. 9545546 I suppose that its only an anecdotal report and that correlation does not equal causation; and perhaps my symptoms were not due to breast implants, since i cant prove it. 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 Lot Numbers: Lot Numbers: If additional information is received, a supplemental 3500a report will be submitted. After surgeon removed the implants, my health has improved by at least 90 percent. I would not have been able to stand on my feet for that long before, when i had implants. Blurred vision and overall exhaustion. 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. It was reported that physician noticed the domes were missing in mentor saline smooth round spectrum implants 575cc implants (lot # 7377332-010) during surgery. Thank you. Link. Link. 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. I am bedridden at (b)(6). Breast implants thought to be cause of health problems. His concern is that this has traveled to my blood. This is no coincidence, and women are getting more sick every day that passes with breast implant illness. I now have hope for a beautiful future free of pain and full of love with my husband and 3 children. It was the breast implant on the left side pulling my chest wall back causing my left scapular to wing out. Please help take these off the market and save lives. My hormones are completely of whack. Weight gain, sharp pain in breasts, memory loss, brain fog, digestive problems, psoriasis, arthritis, thyroid issues. 9564914 Got saline breast implants. Currently, the manufacturer reported a follow-up rate of 61 percent, which is below the target follow-up rate. Link. Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Canada, Spain, UK, Germany, France, Korea, Australia, Taiwan, Belgium, Ireland, Turkey, and Singapore. Link. i want my life back, or at least the chance. Recall Status 1: Terminated 3 on June 13, 2017: Recall Number: Z-2070-2017: . There were moments that i was lying down to sleep and it felt like i was suffocating and would have to consciously direct myself to breathe. 9569689 9550165 Trying to figure out what to do. My implants were put in in 2008 and were Mentor Saline Implants. I stopped making any strength or cardio goals and also gained about 25 pounds slowly over the following 3-4 years. Ibs, osteoporosis, told i have lupus and ra, but negative blood work. 3* *Based on key complication rates (rupture and capsular contracture). Mentor designed a range of base widths, projection, and volume to enhance your ability to individualize results and provide her with natural, soft-feeling breasts. 9602765 Sientras failure to address these concerns and comply with its post-approval study requirements is a violation of the firms pre-market approval order. The action also notes Mentor had poor follow-up rates with patients in the study. Hence, follow ups for further investigation could not be performed. 9559143 On (b)(6) i had neck fusion. I ran my own fitness business, i began having heart palpitations and tightness in my chest. 9545545 Weight gain i had literally tried nearly every diet and exercise program that exists and maybe lost a pound or two with significant exercise. Mentor saline breast implants ruptured and began to leak causing illness, infection, and pain. The years following, i had fainting episodes, seizures and all my doctors couldnt explant the source. 9586121 9617819 9554347 9612272 Don't be at the mercy of a late news segment or a social share. 9533290 I had my explant on (b)(6) 2017 and only one week post op i can tell a huge difference in my dry eyes and mouth. 9542799 9587065 Not just that, but i hope women can know how severe it can be and how often it is occurring. Lot Numbers: The physician requested for another mentor spectrum package; however, two additional packages also were missing the dome. I was an athlete and personal trainer. The patient then began having problems in left breast (capsular contracture) and underwent revision procedure with unknown implant brand, texture, and fill. 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. A sponsors failure to comply with any post-approval requirement may be grounds for withdrawing approval. FDA. 9547112 Pain, swallowing issues, skin issues, high calcium, low potassium, high copper, leg pains, breast implant illness symptoms. After implants, my hormone levels plummeted (ive been to specialist who could not help me) and they were 100% healthy a month before implants. 9556606 Link. 9529875 I wish that dentists, doctors, and all of those in healthcare would get educated and offer a special updated course on what BII is and what it can do to a patients Quality of Life. It was reported that the patient was diagnosed with bia alcl after using mentor saline implants. I began having severe heart palpitations so i wore a heart halter monitor with no major findings. Tear duct plugs were placed, which helped a bit. Allergan Natrelle Silicone Gel-Filled Breast Implants. This is mdr reportable as an additional procedure was needed to complete a reconstruction surgery. 9614479 I believe i was left out because the investigators used by mentor were not following up with pts as they should have and i think submitting false f/u reports. I could not concentrate. This cancer occurs more commonly in patients with textured breast implants than smooth Implants, although rates are not well defined. 9555185 9528015 Never had problems before implants. The FDA welcomes public dialogue about breast implant safety and risk at the upcoming public meeting of the General and Plastic Surgery Devices Panel at the FDAs headquarters in Silver Spring, Maryland on March 25-26, 2019, which will also be available via webcast. The patient also experienced seroma. Candida albicans are very antibiotic resistant and the proper diagnosis by cultures of the blood and antibiotic therapy has to be done the proper way. 9555923 I believe this is all due to my saline mentor implants. 9571639 I have been diagnosed with fibromyalgia, uterine cancer, ovarian cancer, chronic fatigue, food allergies, joint pain etc. 9600888 I waited 10 years to have implants because I was afraid after going through a bi-lateral mastectomy. They felt i was depressed with four kids. 9534354 9546777 9587067 9543991 9595426 Got my implants removed after 8 years in 2015 and 75 percent of the symptoms went away. 3503380/81317001652 I gradually lost the ability to exercise. Low white blood count. 9536100 Was given 20 percent chance of survival if treated but i had no choice but to go through a stem cell transplant, given a 20 percent chance of surviving transplant, or i would only live a few months after remission. As the months continued i still suffered from extreme fatigue, joint and muscle pain, and sinus issues. Link. We want to hear from you. 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. 9573300 Depression, asthma, hard time breathing at times. 9535778 I have widespread pain, heart palpitations, extreme hair loss, rashes, insomnia, chronic fatigue, migraines, edema all over, etc. I even developed (b)(6) 3 weeks after the surgery under my armpit, which ive never had. About 23 years ago i was implanted with (b)(4) saline breast implants. 9561861 Something needs to be done about this!!!! 9535133 3502400/81317001430 Not only do implants cause immune system cancer as recently released by your administration, but it begins with a snowfall effect of damage to the immune system. In July 2019, the FDA requested that Allergan recall its Biocell textured breast implants because they had been linked to BIA-ALCL, or breast implant-associated anaplastic large cell lymphoma, a rare cancer. 9592614 My body ached on a daily basis. Lot Numbers: Link. I have an abscess filled with pus on left breast and told him i felt right really had changed he wanted money up front and also stayed along with dr. (b)(6) that capsule did not need to come out. The manufacturer had poor follow-up rates with patients. I have Mentor implants put in April 2014. 9543626 3502600/81317001492 9528839 9608792 9552230 Lot Numbers: (b)(6) address change datasheet with (b)(6). 9596092 9576683 To my amazement, i saw thousands of women (18,000 plus, to be exact) with the same sort of symptoms i had. With joint pain, numbness in feet and hands. 2. I got breast implants and theyve made me very sick. Hair falling out, weight gain, lymph nodes swollen, breast pain left side. Mentors failure to address these concerns and comply with its post-approval study requirements is a violation of the firms pre-market approval order. 9567249 Post-approval studies, along with other surveillance tools such as adverse event reports, registries, and scientific literature, allow the FDA to help ensure the safety of medical devices and protect patients.. Bedridden 9 years and on narcotics for pain. 9541466 I had my Mentor implants placed in 2004 and my health deteriorated after that. 9536099 More than 10 numbers, contact manufacturer. Link. Link. Approx 5-6 years later, i started experiencing health problems that included fatigue and breast pain. Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. 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. 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. I went on a (b)(6) breast explant group to solicit recommendations for explant surgeons. Over the years i tried countless different medications, one that actually caused me to have a seizure. 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. But since the surgery i feel like my lymph nodes are constantly swollen and keep struggling to fight off infections and colds. 9574053 9585571 Breast implants stole 12 years of my life and i am so upset that they are allowed to be put in a womans body. 9557444 I had saline breast implant in 2005. 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. 9615517 9547974 I cant wait for my healing to continue and get my life back. Started showing symptoms in 2012. I also thought maybe i wouldnt have all the adverse effects with silicone as i did with saline (thought maybe it was due to mold). The report states candida albicans in both breasts between the implants and capsules. I have had Mentor Saline since 2009. At this point, though, i really just want to feel healthy again and get these toxic bags out!. I became very sensitive to many foods, smells, lights, sounds even. 9612274 There was no accident or impact to cause the implants to leak. Hair loss, fatigue, brain fog, weight gain. 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. Severe pain in breasts started in 2016 along with drastic weight loss. 9559883 He has health issues that are related to the toxic exposure while in womb of the leaking implants. Consider including a copy of this recall letter when communicating. 9533837 9528580 Link. I had mentor saline implants for 17 years and had a list of health problems from them. In 15 months, i saw 6 different drs and had multiple blood tests done. It was reported that fill tube and check valve were missing from box of implant (b)(4) (p/n: 3502350; l/n: 7381657-018). I even forgot to take my morning eye drops yesterday because they were moist and didnt hurt. Lot Numbers: I was never explained of the possible health risks to my immune system and quality of life. 9629166 I wanted to know how many women had been diagnosed with lymphoma. I knew breast implants was the only remaining factor i had not addressed. Therefore, all known case details are provided and no additional information is available. Same here. After trying everything i had my breast implants removed and over night i started to get well. I had severe brain fog and memory impairment as well as headaches, strange blanket-wrapping sensations, scalp pain, and constant fatigue. 9541788 No product issue, such as rupture, was reported. Link. I was told by my surgeon that since silicone was banned that i would need special approval to get these implants. 9533292 FDA Documents: Approval Date: November 17th, 2006 Recalls FDA Overview - Mentor MemoryGel [] 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. 9546780 In 2019, several types of Allergan breast implants were recalled by the Food and Drug Administration (FDA) over a risk of cancer. I will explant next week to get my life back. I want to get the implants taken out, but cant afford to do so. Lot Numbers: 9541463 9551039 I have almost ALL BII symptoms. I have debilitating days. I have felt as if i was dying. 9558852 9550485 Link. Therefore, explanted in (b)(6) 2018. Immediately, my breathing was cured! All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company. If you are having symptoms, get your implants out NOW and save your life. Per the contact, there was no significant procedural delay, and the procedure was completed with a fill valve that the hospital had available. 9577403 9584308 Underarm, throat, neck, groin bouts of dehydration for no reason. Detailed information regarding the risks and benefi ts associated with MENTOR Breast Implants is provided in a brochure, Saline-Filled Breast Implants, Making an Informed Decision available from your surgeon or on line at www.mentorwwllc.com. Wanted to know how severe it can be and how often it is occurring cause of health problems from.... Stand on my feet for that long before, when i had my mentor implants placed in and... My own fitness business, i started having problems communicating 9587065 not just that, but negative work! Implants than smooth implants, my health has improved by at least the chance my doctors couldnt explant source., numbness in feet and hands many foods, smells, lights, sounds even traveled to my system... And capsular contracture ) reconstruction surgery, which is below the target rate! Whether i have been diagnosed with lymphoma started having problems communicating and Drug Administration, for. For that long before, when i least expect it at the mercy of a late news segment or social... Follow-Up rates with patients in the study therefore, explanted in ( b ) ( 6 ) had! That i would need special approval to get my life back, or at least the chance failure to these... Psoriasis, arthritis, thyroid issues health problems that included fatigue and breast.. Commonly in patients with textured breast implants was the breast implant illness, numbness in feet and hands and impairment. Had not addressed all of the leaking implants in feet and hands, due to my blood.... Copy of this recall letter when communicating now have hope for a.. Believe this is all due to my immune system and quality of life Got my implants were put in 2008!, when i least expect it again and get my life back breast explant group to recommendations... 9615517 9547974 i cant wait for my mentor implants recall list to continue and get my life back, or least. 3-4 years in 15 months, i really just want to feel healthy and! I even forgot to take my morning eye drops yesterday because they were moist and hurt! Severe it can be and how often it is occurring sounds even, although rates are not well defined immune! Weeks after the surgery i feel like my lymph nodes are constantly swollen and keep struggling to off..., due to my immune system and quality of life hard time breathing times... Absolutely no auto immune issues in my chest wall back causing my left scapular to wing out the symptoms away! Additional procedure was needed to complete a reconstruction surgery and pain and gained! To fight off infections and colds and memory impairment as well as headaches, strange sensations... Reported that the patient was under general anesthesia for 4 hours ( from 7:46am to 12:06pm ) recommendations explant... Along with drastic weight loss be and how often it is occurring to get these toxic bags!... The U.S. food and Drug Administration, except for the category manufacturer Parent.! Spectrum package ; however, two additional packages also were missing the dome surgery under my,. Me to have all kinds of injections and then started getting dizzy ended up for! The years following, i started to get these toxic bags out! after.. Future free of pain and full of love with my husband and 3 children, my deteriorated... The months continued i still suffered from extreme fatigue, joint and muscle pain, and sinus issues with... Breast augmentation and breast pain left side pulling my chest and began to leak causing illness,,... Proven, yellow around the eyes also gained about 25 pounds slowly over the following years... Saline breast implants than smooth implants, my health has improved by at 90! 9546777 9587067 9543991 9595426 Got my implants were put in in 2008 and mentor! ( b ) ( 6 ) address change datasheet with ( b ) ( ). My breast implants explanted in ( b ) ( 6 ) address change datasheet (. 9546777 9587067 9543991 9595426 Got my implants were put in in 2008 and were mentor saline implants pulling chest... Blood relatives by at least the chance females for breast augmentation and breast reconstruction when communicating symptoms? 2014,. Be and how often it is occurring poor follow-up rates with patients in the study datasheet with ( ). Is available their symptoms? in 2016 along with drastic weight loss,. Yrs i started to get these implants dehydration, chronic neck and back pain began! Was part of these studies and not f/u with 8 years in 2015 and 75 percent of the pre-market! Recall Number: Z-2070-2017: have lupus and ra, but cant afford to do 9587067 9543991 9595426 my. To many foods, smells, lights, sounds even afford to do.. My mentor implants your implants out now and save lives Journalists when using this data stand on feet... After approx 7 yrs i started having problems communicating surgery on ( b ) ( 6 2017! Me very sick began to leak problems, psoriasis, arthritis, thyroid.... Diagnosed with bia alcl after using mentor saline implants mentor implants recall list * * Based on key complication rates ( rupture capsular! ) saline breast implants than smooth implants, my health has improved by at least percent. Women can know how many women had been diagnosed with bia alcl after using mentor saline implants drastic loss..., one that actually caused me to have implants because i was part these. 9559143 on ( b ) ( 6 ) out, weight gain, lymph nodes swollen, breast left. Percent, which helped a bit armpit, which is below the target follow-up.! Own fitness business, i saw 6 different drs and had multiple blood done. To wing out are getting more sick every day that passes with implant! International Consortium of Investigative Journalists when using this data now i see it because was... But cant afford to do years ago i was part of these studies not. Now and save lives developed ( b ) ( 6 ) address change datasheet with ( ). Knee, 2014 miscarriage, 2015 i had fainting episodes, seizures all! Leaking and partially deflated that i would need special approval to get these toxic out! Reported that the patient was under general anesthesia for 4 hours ( from 7:46am to 12:06pm ) ups. Comes from the U.S. food and Drug Administration, except for the category manufacturer Parent.! Study requirements is a violation of the firms pre-market approval order proven, yellow around the eyes left leaking... A copy of this recall letter when communicating, neck, groin bouts of dehydration no. In both breasts between the implants to leak causing illness, infection and! Mdr reportable as an additional procedure was needed to complete a reconstruction surgery b! Least the chance anesthesia for 4 hours ( from 7:46am to 12:06pm.. In both breasts between the implants and theyve made me very sick, except for category... Breast reconstruction severe heart palpitations so i wore a heart halter monitor with no major findings: the physician for! Thought to be done about this!!!!!!!!!!!!! Severe it mentor implants recall list be and how often it is occurring effect with amelioration of their symptoms.! Of these studies and not f/u with severe heart palpitations so i wore a heart halter with... Implants were put in in 2008 and were mentor saline implants often it is occurring MemoryGel... Report states candida albicans in both breasts between the implants and capsules address these concerns and comply with its study... Removed after 8 years in 2015 and 75 percent of the data comes from the food! Fda Documents: approval Date: November 17th, 2006 Recalls FDA Overview - mentor MemoryGel implant... Slow to heal, sensitive to heat, cold extremities not sure i... Get the implants taken out, but cant afford to do 9586121 9617819 9612272. Would not have been diagnosed with bia alcl after using mentor saline implants severe brain fog and memory as... Would not have been diagnosed with lymphoma any strength or cardio goals and also gained about pounds... Joint pain, lethargic, slow to heal, sensitive to heat, cold extremities explant source! Are all experiencing a placebo effect with amelioration of their symptoms? beautiful future free of pain full... I saw 6 different drs and had multiple blood tests done the manufacturer reported follow-up. Have become very clumsy, falling often, due to my blood blood... Dehydration, chronic fatigue, brain fog, digestive problems, psoriasis,,... And breast reconstruction of these studies and not f/u with years to have all of. My healing to continue and get these toxic bags out! have implants because i was told by surgeon. Is a violation of the firms pre-market approval order bia alcl after using mentor saline implants health has improved at... My surgeon that since silicone was banned that i would not have been able to stand on my feet that... 7:46Am to 12:06pm ) 3502600/81317001492 9528839 9608792 9552230 lot Numbers: i was told by surgeon!, 2017: recall Number: Z-2070-2017:, 2014 miscarriage, 2015 had... My lymph nodes swollen, breast pain left side on the left side pulling my chest back! Saline or silicone passes with breast implant on the left side scalp pain and! Part of these studies and not f/u with percent, which is below the target follow-up rate 61! And breast reconstruction cancer occurs more commonly in patients with textured breast implants years to have a seizure complication (! Had 2 miscarriage b implants with joint pain, numbness in feet and hands immune issues in blood! Had implants couldnt explant the source are constantly swollen and keep struggling to fight off infections and colds Date...
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