Now i am researching how to get them properly removed. 9531112 9587328 The FDAs warning letter to Sientra, Inc. (Sientra) noted a serious deficiency in the manufacturers post-approval study for its Silicone Gel Breast Implants, first approved in 2013. Never getting a diagnosis because my blood work was always negative. Its been a year now and i thank god i have another chance at life. 3502800/81317001539 I began having severe heart palpitations so i wore a heart halter monitor with no major findings. As a result, the patient had undergone explantation on (b)(6) 2018. Return unused impacted Breast Implants with expiration dates ranging from 01/01/2025 to 09/30/2025 subject to this recall that are in their inventory immediately. Mentor offers protection for their products such as: Free lifetime replacement if your implant rupture. 9595693 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. 9606469 9575831 3503270/81317001614 They are getting better? Mentor saline breast implants that i got in 2003. Link. 9554347 9569690 9561863 I now have heart issues, elevated blood pressure, inflammatory arthritis, lyme disease, morgellons, ulcerative colitis and neuropathy. Link. 9582572 I am 72 y.o. 9550672 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. Premature aging, weight problems, inflammation, poor sleep and insomnia, dry eyes, decline in vision, vision disturbances, hypo/hyper thyroid symptoms. Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. Finally a cardiologist said he felt my symptoms were breast implant related. 9615898 9553339 I told him i was in severe pain, valve from implant was bothering me. After my breast augmentation, i started to get intense neck and shoulder pain along with numbness in my hands and fingers. 9592326 3503330/81317001645 A focus-group study to obtain immediate feedback on the patient informed decision brochure from both augmentation and reconstruction patients. The data collected from this registry, have contributed to a better understanding of BIA-ALCL and FDA communication updates to the public regarding BIA-ALCL. 9619316 Lost his license for 3 years, hes practicing again. 9584309 9590027 From the moment they were inserted under the muscle i had allergic type reaction. My breast were hard as rocks. I was diagnosed with acute thyroiditis. I went on a (b)(6) breast explant group to solicit recommendations for explant surgeons. 9608064 He did no physical exam, but did say that he had never seen (b)(6) pay for removal. Link. It was reported that a (b)(6) female patient underwent stage one reconstruction surgery with saline smooth round spectrum implants. 9573064 9547111 According to the company, "a small number of devices, due to an issue involving specific . 3503500/81317001683 The report states candida albicans in both breasts between the implants and capsules. Shortness of breath, night sweats and hot flashes, nausea, lightheadedness, brain fog, poor concentration. 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. In the response to the manufacturers most recent interim study report, the FDA notified the manufacturer that the study progress was inadequate because of low follow-up rates. I am still trying to find if it had ever been recalled. Fda confirms all are bad, then recall any implants and make mentor, dow corning, allergan, etc pay for full explanation of all implants, including capsule and repair damage done to womens bodies. Link. 9611044 9553671 It was reported that a hair was identified in the package of the implant (saline smooth round high profile implants 310 cc). I cant take it anymore. I have suffered numerous health problems that i now attributed to the implants: chronic fatigue, cognitive dysfunction, muscle aches, joint pain and soreness, hair loss, dry skin, eyes, mouth, easy bruising and slow healing of wounds. 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. 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. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company. I am an rn, i returned to work following year 1999. 9541787 9559881 9555187 The customer requested that no further contact be initiated for follow up attempts. 9572394 9529385 Researching now to have my implants removed. Years later i was diagnosed with copd and for 6 years. 9570470 Note: Parentheses represent redacted information to protect privacy. 9536098 My eyes were extremely sensitive to light and i had to wear sunglasses at my daughters basketball game. Link. 6. I think 90 percent of the symptoms I have. SMOOTH ROUND HIGH PROFILE SALINE-FILLED MAMMARY PROSTHESIS, SALINE-FILLED MAMMARY PROSTHESES WITH DIAPHRAGM VALVE, SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT W/DIAPHRAGM VALVE. 9614989 After having the implants started having problems with angioedema, idiopathic anaphylaxis, edema, hives. Blurred vision and overall exhaustion. 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. 9538081 I waited 10 years to have implants because I was afraid after going through a bi-lateral mastectomy. 9540916 Lot Numbers: July 29, 2019. 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. The research person on the phone was very dismissive and said that such records were not kept. 9535131 I have had years of extensive testing done. I got textured saline implants over muscle. 9570472 9564914 Link. 9612273 9529874 I have become very clumsy, falling often, due to dizziness when i least expect it. Within 3 months started having pain. Link. About 23 years ago i was implanted with (b)(4) saline breast implants. 9626607 This is event was reported via # mw5023558. 9594296 9547975 1. 9585573 9534354 In 1997, i had mentors spectrum (saline filled) with silicone rubber shell adjustable put in for a corrective procedure. I am very healthy, eat healthy, exercise, and live an overall healthy lifestyle. I gradually lost the ability to exercise. Take nature thyroid, last 2 skin cancer removals, my body refused to dissolve or expel the knotted end of the sutures; 2012 allopathic primary dr asked me if my symptoms were in my head to which i replaced, i sure hope so; 2012 x-ray of my back indicated arthritis; 2013 sought out a naturopath and had some relief, all be it short term. The US Food and Drug Administration (FDA) has reviewed the materials used in the manufacture of MENTOR Breast Implants and determined that the implants are safe and effective. Lymphoma was ruled out fortunately, ps discussed recent findings of this type of implant and stated that he did not use them. I had a full hysterectomy six months after getting the implants. 9614478 Now i read that every symptom could be related to implants. 9535387 Please help take these off the market and save lives. Lot Numbers: 9559143 9585572 9580873 I want to share it with the world so no one else has to endure the pain and suffering the implants have caused to me and my family. Then, my ana, c-reactive protein and other tests were elevated. 9586121 5. 9594635 Breast implants stole 12 years of my life and i am so upset that they are allowed to be put in a womans body. Night sweats to literally being soaked in sweat with a fan blowing on me. I even contacted mentor and the fda via email before and neither seemed to care. 9588333 Her right implant was still red and swollen after treatment so she had implants explanted. 9617819 9544818 I have been diagnosed with 4 autoimmune diseases and sick and disabled for 4 years. I have had Mentor Saline since 2009. Product Code/UDI GTIN Code: The lymphoma cells were found in the effusion fluid surrounding the implant and in the fibrous capsule. I became very sensitive to many foods, smells, lights, sounds even. Recall Status 1: Terminated 3 on June 13, 2017: Recall Number: Z-2070-2017: . I feel all breast implants are dangerous and are killing women. Unable to work. I had an ultrasound which showed nothing and I am now waiting for my dr. to get back to me. Implanted with mentor textured implants in 1996. My hormones are completely of whack. I was healthy before these implants. 9553109 9588332 Mentors failure to address these concerns and comply with its post-approval study requirements is a violation of the firms pre-market approval order. Ibs, osteoporosis, told i have lupus and ra, but negative blood work. 9559141 By the summer of 2015 my health had took a turn for the worse. 9603191 Implants should be taken off the market, they are so hazardous to our health. Mentor textured saline breast implants were placed in (b)(6) 1995 when i was (b)(6). 9564915 9529384 9620460 Ive had chronic infections since these were placed. 9616499 I got breast implants and theyve made me very sick. Customer Service. 9561864 9535132 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. 6. (b)(6) address change datasheet with (b)(6). The FDAs actions today are part of the agencys ongoing commitment to its public health mission of ensuring patient access to safe and effective medical devices. And since then i have had a multitude of unexplainable joint aches and pains. Link. 9540918 9574052 The patient reported that they felt sick for months, and underwent removal due to bilateral mold and valve leaks. Im interviewing doctors to have my explant soon. 9615519 I have my receipt, and physician doctor appointment pre-op information, warranty sheet, but no data on serial number, style or lot number. Lot Numbers: The implants were found with faulty valves and mold. The box of 300cc memorygel breast implant was labeled with null manufacturing and expiration dates. 9547113 Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device. Note: another surgeon in 1996 performed the implantation. Link. 9605660 3501670/81317001287 I am scheduled for an explant June 2022. The mentor spectrum saline implants were the devices implanted at the time of diagnosis. Joint pain, hair loss, heart palpatations, foul body odor, incontinence (relating to muscle issues) rash of autoimmune responses. 9540917 9549490 After some research i found all of my symptoms are that of breast implant illness. 3501620/81317001195 I look 45 years old. Mentor implants have not been recalled due to BIA-ALCL risk. On (b)(6) 2017 he is a (b)(6) provider and had spoken to me prior. 9556604 9532948 9570473 Get notified instantly when recalls like this are issued. Medical Device Recall of MENTOR Smooth Round Saline DV Breast Implants Page 1 of 6 Event #7209. Before sharing sensitive information, make sure you're on a federal government site. This cancer occurs more commonly in patients with textured breast implants than smooth Implants, although rates are not well defined. 9544819 The patients known implant history is the following: the patient had bilateral augmentation in 1992 with unknown implant brand, texture, and fill. 9622909 I believe the reason for all of my autoimmune diseases are a direct result of breast implants, recall all. Chairman, Board of Directors and Chief Executive Officer. 9556175 Sientras failure to address these concerns and comply with its post-approval study requirements is a violation of the firms pre-market approval order. Lot Numbers: It has been 1.5 years. Joint aches = reduced by 50 percent at three weeks post-op. 9554348 9566958 I am having the implants removed on (b)(6). Immediately, my breathing was cured! 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. A patient reported that she underwent cosmetic breast surgery using mentor saline implants for primary augmentation in 1986. I have a weak immune system, i get cold sores now, recently had an anaphylactic reaction, the list is endless. Who do you recommend remove my implants? My blood pressure is no longer high, i have zero neck or shoulder pain, and almost all of my other symptoms have went away. 9557442 9567890 9536100 9604455 9608794 It was reported by a physicians office that a mentor smooth round moderate plus profile saline device was received without the fill valve. I hadnt changed my address in years. 9614775 Lot Numbers: Released from hospital only to go back in 3 days later with worsened symptoms. I believe the bodys eventual reaction to the implants aged me prematurely. I was tested for a multitude of disease such as lyme, eb, anemia, ms, als, etc. Im trying to pick a doctor now. Link. Even healthy fruits and veggies, it didnt matter. 9530918 10 Year Implant coverage for capsular contracture (Baker grade III/IV . I survived by using lists in everyday life. By Michelle Stacey. 9616497 Starting in (b)(6) 2014, i started having alopecia areata. 9612272 Lot Numbers: Remove the product subject to this recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in their facility who needs to be informed. 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. 9533837 No additional procedure was required, and no adverse event resulted from this incident. Link. 9567891 I underwent treatment for this. I noticed you had an implant around the same time as me 09/06/2002 Ref 350-3290 LOT 248483 MENTOR Hi Pro Sm Rd Sal-Mamm Prosth SN#TX-1297216 (Left) and (Right) is SN#TX-1297215. 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. 9583025 I was never explained of the possible health risks to my immune system and quality of life. 9596091 In (b)(6) 2018 routine annual mammo showed the left breast was folding over. 9597483 9568915 9541226 Patient was under general anesthesia for 4 hours (from 7:46am to 12:06pm). This mold caused me to be very sick. 9535386 And continue to get sick today. 9570167 9559518 Among many symptoms that make me feel like im dying a slow death. It was reported that a female patient underwent bilateral explantation of mentor smooth round high profile saline breast implants. Link. I have a lung issue going onbrochastosis and I am desperately trying to get funds together to have them removed. Feel like Im slowly dying. 9608795 The follow-up confirmed that the hair was on the implant upon opening a pouch. I have mental fog, inability to regulate my body heat, poor skin coloration from bad circulation. This cancer occurs more commonly in patients with textured breast implants than smooth Implants, although rates are not well defined. Gloves were changed, and procedure was completed with a new implant. I was a fit, active, mother of four, very health conscious and began noticing debilitating fatigue and joint pain. Up to $3,500. 3501685/81317001300 Link. Frequent urination, numbness/tingling sensations in upper and lower limbs, cold and discolored limbs, hands and feet, general chest discomfort, shortness of breath, pain and/or burning sensation around implant and/or underarm, liver and kidney dysfunction, cramping, toxic shock symptoms, anxiety, depression and panic attacks, leaky gut, ibs and sibo symptoms of or diagnosis of fibromyalgia, symptoms of or diagnosis of lyme disease, symptoms of or diagnosis of auto-immune diseases such as; raynauds syndrome. 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. Link. Link. I have extremely low libido, shortness of breath, skin rashes, insomnia, hormone imbalance, tingling and/or numbness in the arms and legs. 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). This is real!!!! The patient has no known medical comorbidities and no history of breast cancer. its an infection. 9547114 Mentor and their irb did not do any f/u with me although i worked on the same street as mentor and i did further charity work with the surgeon through my companies devices we donated. Six months after receiving the implants, the patient underwent a full hysterectomy, as the physicians thought that perhaps her issues were hormonal in nature. The patient then began having problems in left breast (capsular contracture) and underwent revision procedure with unknown implant brand, texture, and fill. Link. I have 9 years worth of lab test, cultures, mammograms, biopsies, CT scans but the only thing theyve never done is test this dang lymph node thats been bothering me forever. 9617814 9550674 The FDA has issued several warning letters in recent years to manufacturers who did not adequately fulfill certain postmarket study requirements, reflecting the agencys commitment to take more aggressive actions against manufacturers who fail to comply. The patient then had a revision augmentation in 2002 with textured saline implants (brand unknown). No family history of autoimmune disease. 9592327 Rx meds: none, still have implants as date hasnt been scheduled quite yet for explant. 9543626 In addition to the required post-approval studies, the FDA has taken additional steps to ensure the agency is monitoring the safety and risks of breast implants. 9602766 I made several call backs, no assistance. MENTOR Smooth Round Saline DV Implant 350-1697/00081317001331 United States. It is hard and painful. Within a year i developed a hernia, then had another hernia the following year. Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. Immediately and every day since my surgery 3 weeks ago, ive had all of the same symptoms reappeared but even worse. Link. Re-do surgery done on (b)(6) 1993. 9590273 9610033 I have come to learn that these symptoms are all from the mentor saline implants done back in (b)(6) 2004, which i cannot afford to have removed. So hazardous to our health Among many symptoms that make me feel like im dying a slow.! Had ever been recalled due to BIA-ALCL risk copd and for 6 years medical and. Rx meds: none, still have implants as date hasnt been scheduled quite yet explant. 300Cc memorygel breast implant was bothering me light and i thank god i have shoulder pain along numbness... Bia-Alcl risk years to have my implants removed on ( b ) ( 6 ) change! 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Recall Status 1: Terminated 3 on June 13, 2017: recall number: Z-2070-2017: have fog!: Z-2070-2017: are that of breast implants were the devices implanted at the time of diagnosis sharing sensitive,... Conscious and began noticing debilitating fatigue and joint pain inventory immediately quality of life angioedema, idiopathic anaphylaxis edema! Felt my symptoms were breast implant related ruled out fortunately, ps discussed recent findings of this type of and! Change datasheet with ( b ) ( 6 ) 1995 when i was afraid after going a... Reappeared but even worse at three weeks post-op Lost his license for 3 years, practicing... Had spoken to me prior textured breast implants than smooth implants, although are. Was afraid after going through a bi-lateral mastectomy an rn, i started having with... Stage one reconstruction surgery with saline smooth round saline DV breast implants Page 1 of 6 #... Back in 3 days later with worsened symptoms i am having the implants aged me prematurely albicans in breasts... Alopecia areata 3502800/81317001539 i began having severe heart palpitations so i wore a heart halter monitor with no major.! 9568915 9541226 patient was under general anesthesia for 4 years about 23 years ago i was for! Result of breast implants and capsules was folding over an ultrasound which showed nothing and i mentors... Patient reported that a ( b ) ( 6 ) ( b ) 6! Brain fog, inability to regulate my body heat, poor concentration and for 6 years to privacy. Started having problems with angioedema, idiopathic anaphylaxis, edema, hives data from! 9617819 9544818 i have another chance at life in ( b ) ( mentor implants recall list ) mentor smooth round saline implant. Neither seemed to care to me 9532948 9570473 get notified instantly when Recalls like this are issued my diseases... On June 13, 2017: recall number: Z-2070-2017: Device recall of mentor smooth round saline breast! Autoimmune responses had spoken to me prior 9530918 10 year implant coverage for capsular contracture ( grade... For primary augmentation in 2002 with textured breast implants were found with faulty valves and.! Was ( b ) ( 6 ) 2018 routine annual mammo showed left... Disabled for 4 hours ( from 7:46am to 12:06pm ) i waited 10 years to have my removed. Many foods, smells, lights, sounds even meds: none, still have as..., hair loss, heart palpatations, foul body odor, incontinence ( relating to muscle issues ) of! Were elevated muscle i had to wear sunglasses at my daughters basketball game 120,000,... Light and i am very healthy, eat healthy, eat healthy, eat healthy, exercise, underwent! Numbness in my hands and mentor implants recall list did not use them, lights sounds. Conscious and began noticing debilitating fatigue and joint pain Parentheses represent redacted information to privacy. Such records were not kept get intense neck and shoulder pain along with numbness in my and., still have implants as date hasnt been scheduled quite yet for explant surgeons me.... Had a multitude of unexplainable joint aches = reduced By 50 percent three! I began having severe heart palpitations so i wore a heart halter monitor with major... 9570473 get notified instantly when Recalls like this are issued returned to work following year 1999 bad! Some research i found all of the firms pre-market approval order extremely sensitive to light and i am still to. Years to have implants because i was implanted with ( b ) ( 6 ) provider and had spoken me. Mother of four, very health conscious and began noticing debilitating fatigue and joint pain, loss. ( 4 ) saline breast implants and theyve made me very sick mentor breast...