My implants were put in in 2008 and were Mentor Saline Implants. It wasnt until i discovered a website about breast implant illness that i put it all together. To receive credit reimbursement, customers must return product subject to this recall. 9574053 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. Its clear that the silicone toxins released through the shells were attacking my autoimmune system. A sponsors failure to comply with any post-approval requirement may be grounds for withdrawing approval. FDA. I requested pathology be done. Please do something. 9553337 I know something is going on, but because doctors have deemed me a mystery, I dont want to see anyone. 9561862 9530916 Lot Numbers: I had mentor smooth round moderate profile saline implants placed in 2013. 9571294 MENTOR Smooth Round Saline DV Breast Implants (Lot Numbers with Expiration Dates from January 01, 2025 to September 30, 2025) Its as if their symptoms mirror some of which Im suffering from. Patient was under general anesthesia for 4 hours (from 7:46am to 12:06pm). 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. Im feeling lost & consumed with chronic pain. I am totally suffering also. Affected products Filter items Showing 1 to 3 of 3 entries Show entries Issue My primary care physician cannot come up with any findings related to my overall health except that the fact my body is being compromised by breast implants that were deemed safe. 9594635 Lot Numbers: 9545546 3501680/81317001294 I want them removed as soon as possible because i know they are toxic and my body is reacting to them. Never had problems before implants. I have become very clumsy, falling often, due to dizziness when i least expect it. 9611602 Link. This didnt add much time to the procedure. 9540919 I couldnt eat anything without instantly bloating. It was reported that a (b)(6) year old female patient who underwent breast prostheses implantation in 2009 with mentor saline smooth round moderate plus profile implants 350cc (catalog # 3502350, lot # 5915659) experienced bilateral discomfort and aching. I was treated by several different dermatologist with steroids im as well as into the bald patches on my head. 9624985 9614479 He did no physical exam, but did say that he had never seen (b)(6) pay for removal. Explanted (b)(6). Manufacturer Mentor Texas, LP. Anyone, who enters my world must be fragrance free or i get an automatic headache. I was (b)(6) at the time. Your complete guide to recalls, "breast implant illness," and the conversation surrounding them. 9562724 9595691 9582571 He believed i had sleep apnea. Patient outcome has since improved, with lingering food allergies, gut issues and mold/chemical sensitivity. Ive had multiple lyme tests done that were all negative. Spine pain (not the same as back pain, more of a tender spine). Chronic fatigue, inflammation, insomnia, cognitive dysfunction, skin rashes, headaches, sore and aching joints of shoulders, hips, backbone, hands and feet. Mentor saline breast implants caused hashimotos and sjogrens auto immune. 9606471 Note: Parentheses represent redacted information to protect privacy. Consider including a copy of this recall letter when communicating. Patient had implants in for 10 yrs. 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. Was given two weeks to live if no treatment. 9603191 Lot Numbers: Blurred vision and overall exhaustion. 9541788 I am an rn, i returned to work following year 1999. MENTOR MemoryShape Breast Implants MENTOR Saline Breast Implants FDA Approved Made in the USA Implant Fill Proprietary cohesive gel which holds together uniformly to better resemble a more natural look and feel Proprietary highly cohesive gel that retains shape and has a natural feel. Mentor offers protection for their products such as: Free lifetime replacement if your implant rupture. I have had numerous disabilities and health issues ever since ranging from thyroid issues, chronic fatigue, cognitive dysfunction, muscle pains and weaknesses. Immediately, my breathing was cured! 9535131 Product: Mentor Smooth Round SPECTRUM Post-Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048: Code Information: Lot Number: 7377332: . 9533837 Please help take these off the market and save lives. Turns out the textured implants are made with platinum, the same agent used in Cisplatin chemotherapy which causes a permanent ringing in the ear. 9535775 I had an mri conducted with and without contrast and saw an ms specialist who was not concerned that i had ms. 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. This is event was reported via # mw5023558. Saw an ent and was told i needed to get my deviated septum fixed and thats why i was so tired and had sinus pain. 9608404 3501650/81317001256 Link. I recently fell on (b)(6) 2017 saw a md next day. I love my breasts but I have SO MANY of the symptoms listed here. Three factors determine lasting satisfaction: Technique and expertise, placement and patient body, and safe and high-quality implants.9 Before Your First Surgery 9557443 9543626 Issuing Office: Center for Devices and . 9596093 I was a health woman before I put them in and wish I never had. At this point, though, i really just want to feel healthy again and get these toxic bags out!. Ibs, osteoporosis, told i have lupus and ra, but negative blood work. Mentor smooth saline almost killed me, Ive explanted two weeks ago and Im getting my life back. I now have heart issues, elevated blood pressure, inflammatory arthritis, lyme disease, morgellons, ulcerative colitis and neuropathy. The patient underwent explantation with replacement on (b)(6) 2016 when the surgeon noticed mold in the valve area of both implants :it was described as dark green, brown and black and it was reported that some particles were also in the patient. Shortness of breath, night sweats and hot flashes, nausea, lightheadedness, brain fog, poor concentration. 9590273 All of my joints and muscles hurt so bad. They are poison and doing this to so many women. As a result, the patient had undergone explantation on (b)(6) 2018. From the moment they were put in my body, my immune system reacted to everything. 5. All symptoms continued to worsen until surgical removal with total encapsulectomy bilaterally in (b)(6) of 2017. 9574052 I even forgot to take my morning eye drops yesterday because they were moist and didnt hurt. I even contacted mentor and the fda via email before and neither seemed to care. 9617819 It has been 1.5 years. 9578066 9530517 I have right breast fullness, burning, right arm feels heavy, and my armpit lymph node like always when Im sick is swollen. 9558853 Mentor Saline Breast Implants IMPLANT SERIAL NUMBER RECALL Products can fail, either instantly or over the years. 9570169 9530516 Lot Numbers: The symptoms seem so unrelated that its the last thing you would think of even being as sick as i was. I was given chiropractic and physical therapy treatments that did not help. 9534031 9597481 Im interviewing doctors to have my explant soon. Lot Numbers: 9590027 The correlation makes sense to me. 9555924 Lot Numbers: 9539273 A lower risk of complication is rupture. But after seeing further specialist they said the sle was not my genetics but being caused by an autoimmune response to an unk source. a nurse since (b)(6), i find this deeply disturbing. 9617100 9584037 9563941 Link. Blood tests for sjogrens disease, came back negative, due to my dry mouth. The restrictions on sale and distribution are included in the Post-Market Approval (PMA) Supplement Approval letter for these implants. You can download a raw copy of the database here. Difficulty concentrating, muscle weakness, dry skin and hair, headaches daily, migraines, monthly, irritable bowel. I had very high levels of several heavy metals in my blood. 9570470 Before sharing sensitive information, make sure you're on a federal government site. 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. 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. Chronic fatigue, body pain, brain fog, dry eyes. Two Florida women filed a $5 Million dollar lawsuit against Allergan as a result of the recall. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements. Something needs to be done about this!!!! Right had capsular contracture. I had lime green nipple discharge on the right side and blood coming out the left breast nipple. Lot Numbers: 9570471 9570168 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. 9533840 Finally, the FDA notified Mentor that there were significant data inconsistencies in the study, including poor patient accounting and missing race and ethnicity data. It was reported that a (b)(6) caucasian female patient who underwent primary breast augmentation on (b)(6) 2009 developed bilateral baker grade unknown capsular contracture. My aerobic capacity diminished and recovery from my own personal workouts was long. 3502600/81317001492 I had many headaches and so much brain fog that it was difficult to do my job as an actor who is supposed to memorize lines. Then, my ana, c-reactive protein and other tests were elevated. My eyes and mouth became unbearably dry. Scroll down for a list of symptoms women have reported to the FDA and for reports of mold, manufacturer issues, BIA-ALCL, other cancers, body parts removed, and pre and post approval study follow-up. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company. 9574860 I began to experience anxiety and panic for unknown reasons so i began increasing my b vitamins, but nothing helped. Extreme fatigue, sinus pain and achy. I went to see dr. (b)(6) in (b)(6). It is hard and painful. 9541465 Physician opened another set of implants (lot # 7377332-033) however it was missing domes as well. I was never explained of the possible health risks to my immune system and quality of life. After implants, my hormone levels plummeted (ive been to specialist who could not help me) and they were 100% healthy a month before implants. 9619995 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. Rashes = gone. 9575831 9553109 Link. 9563098 Distributed in the states of NY, WI, CA, TX, CO, NC, NJ, OH, TN, RI, and IL. 9617818 Shaky hands, high cholesterol, not a high fat diet. I will tell my story, and would never recommend breast implants to anyone. I am still trying to find if it had ever been recalled. Link. My ana was positive right before explant (b)(6)2017. The patient didnt experience systemic symptoms such as fever, night sweat, or weight loss. 9550164 9561195 9578064 The FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace. United States Their immune systems are overreactive to everything. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. 9580876 9612272 Link. I still struggle with gut issues and joint pain. 9528840 Link. Please look at breast implant illness and healing by (b)(6). 9582861 Sientras failure to address these concerns and comply with its post-approval study requirements is a violation of the firms pre-market approval order. (A black and white photo copied paper) I live in Texas now, decided to call my PS from IL., only to discover he closed his office in 2008 after a narcotics, fraud charge. Some insurance companies with assist i having them removed if there is a rupture or they were implanted for reconstruction due to cancer, but i could not find a plastic surgeon that would take them out with insurance paying. Researching now to have my implants removed. 9615518 3503460/81317001676 9573299 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. Or have experience with a medical device? January 2020 kidney stones removed, blood work pretty good other than low iron still, then in November 2020 high liver enzymes and 2021 diagnosed with autoimmune hepatitis. the patient underwent testing but everything returned negative for disease. 3503290/81317001621 9541784 9556176 This is not ok!!!!! People are dying, others are struggling to survive. I recently explanted in (b)(6) 2016. 3503420/81317001669 On (b)(6) 2004 i had mentor saline implants put in by dr. (b)(6) in (b)(6). Most recalls are not even mentioned in the mainstream! After some research i found all of my symptoms are that of breast implant illness. I have been holding off getting the implant I need because I a 72 and I want the same profile sagging that I have in my other breast. 9553108 3502450/81317001454 He is wonderful and said I was having a reaction to the implants, and that they needed to come out immediately. This was the month and year i started having heart palpitations, inability to exercise, chronic fatigue, numbness, neck and back pain, frequent fevers, anxiety, lightheadedness, profound muscle weakness, couldnt recover from anything, feeling like i was literally going to die. 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. 9535773 9595693 Link. The patient underwent removal without replacement on (b)(6) 2018. 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. Irving TX 75038-3524. This report is for the one of the two implant. Link. I had my Mentor implants placed in 2004 and my health deteriorated after that. 9531111 Sent to cardiac physician who diagnosed me with cardiomyopathy by reviewing the ultrasound and other tests. 5. 9550165 9573064 MENTOR Smooth Round Saline DV Implant 350-2175/00081317001348 I had the implants removed at the end of 2015. 9557445 My body took twice as long to recover from surgery, childbirth, and everything in between. 9567251 Note: another surgeon in 1996 performed the implantation. 9554349 I had mentor saline breast implants augmented under the muscle in (b)(6) 2006 at the age of (b)(6). Breast Implant Ingredients. 9531110 9604456 Do you think that made a difference in the muscle deformity? After 4 years i developed a cyst in my right shoulder that was so large it had to be surgically removed. 9559143 9547112 I am having horrible issues and what mine out! Link. In 2015, doctor found lump in right breast, mano shows calcification on left, right has 2 cyst at 10 oclock, had biopsy ductal plasia on right breast, had breast mri last week. I had my explant bilateral capsulectomy 01-14-2020 and am grateful to #1 GOD and secondly to all the medical community including my dentist that recommended a TMJ Pain Specialist who made me realize I was taking way too many prescriptions over a decade and some were opiates. It was reported that a female patient was implanted with mentor smooth saline breast implants in 2002. 9594633 3501625/81317001201 9605660 Chief resident dr. (b)(6) verified breast deflation, but did not allow an appt, that is coveted by (b)(6). Adrenal fatigue. Its three weeks post-explant and im down 7 pounds with a completely sedentary existence while recovering from surgery. Get notified instantly when recalls like this are issued. 9575829 This mold caused me to be very sick. I got my implants in 2010. Breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). But my right breast has for the last few years been inflamed and has drainage. The most common complications for breast reconstruction with MENTOR Saline-filled Breast Implants include re-operation, implant removal, capsular contracture, breast pain, and implant deflation. Link. Customer Service. 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