In a matter of 48 hours one breast swelled and i went to see my plastic surgeon. I was diagnosed with ulcerative colitis back in 1986 since ive had the saline implants removed and silicone replaced them, i have been extremely ill and never once did a doctor suggest it could have been for my implants. Here are my symptoms: hormones are imbalanced (out of wack), hypothyroid. Approx 7 years ago, i had a breast augmentation done, re-done actually. Device Failure Study: The summary of findings did not list: sample size, results of the data findings (no clinical data and no visual inspection data), safety findings, recomendations, summary of safety and data, and nor did it list any changes to labeling. She was diagnosed with rheumatoid arthritis one year later. I have constant infections. Mris of brain to check for memory related causes were inconclusive. Mastectomy reconstruction revision for deformed reconstructed left breast. There should be some kind of warning about the dangers of breast implants. Mentor Worldwide Historical Implant Data 1985 May 2018. I was given iv cipro for several days. The patient had a mammogram done on 10/20/2015 that showed some micro calcifications in the left superior breast and recommended patient attempt to obtain prior mammogram images for comparison and for additional imaging (spot magnification views) to evaluate the micro calcifications. Skin issues were addressed with various creams/meds, none which resulted in improvement. Update on the Safety of Silicone Gel-Filled Breast Implants, MemoryShape and MemoryGel Post-Approval Study. )7:Evvc},,dK9%"Ty.73&X6H(TQzz?n7?"=O[U? The patient reports that the device was explanted on (b)(6) 2017. Within 3 hours of the mammogram i felt very ill, and had hives on my torso. Link. Used in breast reconstruction surgery, MENTOR CPX TM 4 Breast Tissue Expander is designed to expand primarily in the lower portion of the breast, so the resulting pocket will accommodate the implant and slope like a natural looking breast. Irving TX 75038-3524. Link. (1/5/17). Sometimes cant even have a bra touch it. Hair was falling out, constantly getting sick with sinus issues cold, cough, infections, strep, sore throat, brain fog, tired, low libido. Had breast implants put in and have had failing health since. I obtained a family doctor at this point who subscribed thyroid meds and followed me with maintaining therapeutic tsh levels. I was no longer able to work and was placed on disability. This event was reported via # medwatch (mw5032276). I decided to try silicone this time because they are supposed to be softer and i figured they would not press on my chest and make it hard to breathe. Eventually by 2007 both implants were capsulized. FDA Determined. Link. I had silicone gel breast implants placed under the muscle. Breast tissue was not sent for histology at that time. So, i had the surgery to replace them and it was an absolute breeze! Second, the FDA approved new labeling for all legally marketed breast implants that includes: The breast implant manufacturers have posted the updated device labeling to their websites. MENTOR Smooth Round Saline DV Breast Implants (Lot Numbers with Expiration Dates from January 01, 2025 to September 30, 2025) I began using a cane, then a walker, and eventually had to be pushed in a wheelchair. Team of doctors at (b)(6) clinic couldnt figure out what was happening to me. Heart palpitation, swollen and tender lymph nodes in breast area, underarm, throat, burning sensation around breast implant and arm pit, bladder pressure pain. 350-3460. 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. Choose whether you want a refund, repair, or replacement. My upper body muscles ache, and i continue to have difficulty sleeping. I have developed severe symptoms over the past two years to include: worsening peripheral neuropathy, muscle/joint/bone pain, and weakness, tremors, dizziness/blackouts, seizures, severe fatigue, mental confusion/forgetfulness, difficulty speaking, went into acute liver failure twice, weakened immune system/recurrent infections, rashes, wounds that wont heal, mood changes, heart palpitations, etc. She was scheduled to remove implants the following month. Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English, Prosthesis, breast, noninflatable, internal, silicone gel-filled, Code of Federal Regulations (CFR) Title 21 7.55. Have had blood tests where discovered i had thyroid issues and then found out i had hashimoto. It was reported that the patient has suffered bodily injury and resulting pain and suffering, disability, mental anguish, loss of capacity for the enjoyment of life, hospitalization, medical and nursing care and treatment, loss of ability to earn money in the future. Ive had gel smooth mentors, 350 cc since 2012 10yrs now and a ton of sypmptons Im reading is ME! Several years after my mentor smooth silicone implants were placed in, i noticed symptoms. I even developed (b)(6) 3 weeks after the surgery under my armpit, which ive never had. }_t}yOi*/ )BY|M ty$'^T8a*7ffDUd8IiQq|VV/_N\rHpSVwtL|8QTFTT{=x?+9R2g*ORG Two doctors felt there was no rupture!!!! The patient also reported breast pain which appeared in 2016 along with lump in her breast. Do your research ladies, get a $$ loan if you have to, your health is worth it! 11. I actually held the implant and was assured the silicone would not leak out and if implant were punctured, the silicone would remain inside implant. In 1998, i had a reconstructive surgery and mentor brand, textured, silicone implants were implanted. Some respondents suggestedthat the true purpose of the brochure was to protect Mentor, rather than inform patients about breast implant surgery. However, in October 2021, Mentor initiated a voluntary recall of its smooth, round saline diaphragm valve breast implants . I am hoping my upper back pain goes away and my health recovers. Shortness of breath (feel like i cant catch my breath). Since that date my health has steadily declined with a fast decline noted after 2. Fibromyalgia, ms symptoms high blood pressure, chronic fatigue, ibs burning sensation in body, frostbite sensations on outside of my body. I had the implants removed at the end of 2015. Due to memory issues and based on disclosure of history only, one doctor diagnosed dementia. The surgeon noticed a piece of plastic that was attached to the outside of the shell. 1 MENTOR Breast Implants are backed Researching implant serial numbers and tracking down your Mentor breast implant provider takes time and effort. Previous to implants i was on medication for thyroid issues, but nothing else and was in very good health. I was implanted with mentor memory gel silicone breast implants. I was able to have a visiting nun come once a week also. I happened to notice that one of my breast implants (from breast cancer in 2000) had gone flat. I couldnt think clearly, and i could not sleep. (Unknown if it is Mentor saline or silicone). An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Risks and Complications of Breast Implants, Medical Device Reports for Systemic Symptoms in Women with Breast Implants, Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma, Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), Things to Consider Before Getting Breast Implants, Breast Implant Postmarket Safety Information, FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants, Breast Implants - Certain Labeling Recommendations to Improve Patient Communication, Saline, Silicone Gel, and Alternative Breast Implants guidance, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders. They discharged me and less than 12 hours later I went to a different hospital. The mammogram film showed the bursting of the implant. I had the breast implants removed on (b)(6) 2015 and began the process of detoxing the chemicals and heavy metals that are in silicone gel breast implants. Link. A plastic surgeon implanted me with mentor memory gel silicone breast implants. Dryness of mouth, hair, skin, and scalp sores, choking at night afraid, i wouldnt wake up. The patient did not report any other symptoms and did not want to return the devices back for failure analysis. Weight gain, heavy and abnormal menstrual cycles, heart palpitations, chronic diarrhea, muscle cramping/frequent charlie horses, frequent swollen and sore lymph nodes usually under arms sometimes neck, sensitive eyes, enlarged thyroid, allergies for the first time in my life, pain where the ribs meet the sternum. 350-3250 For our MENTOR Breast Implants, if a rupture occurs within 10 years of surgery, you will also be eligible for up to $3,500 in nancial assistance for surgical costs. Along with that were 35 other symptoms. 350-3420 6. MENTOR MemoryGel Breast Implants are offered in many sizes and profiles: Moderate Plus, High Profile, Ultra High Profile, Moderate Plus Xtra and High Profile Xtra. Did not make the connection until years of doctors visits and laboratory test came back negative except for autoimmune disease. Link. If a patient declines to provide personal, identifying . I feel weak more as time goes by. I have been unable to return to the job that i loved. I started having sensitivity to foods which i never had before and the foods cause pvcs. Some days cant get out of bed. Summary of the Safety and Effectiveness of Mentor's MemoryGel Silicone GelFilled Implants in Patients who are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, or Revision. Each implant is filled with the Mentor proprietary cohesive gel that holds together uniformly and retains a natural give that better resembles breast tissue. Within two months of my operation, i had an odd perspiration odor which remained with me permanently. Updated labeling to communicate long-term study results may not be available for all implants in this table. MENTOR MemoryGel Breast Implants and MENTOR MemoryGel Xtra Breast Implants are round devices with shells constructed from medical grade silicone elastomer. Also, gel fracture is a new phenomenon that has been identified for . I felt like i was dying. The health consequences of a ruptured silicone gel breast implant have not been fully established. Loss of appetite, weight loss. Since I had them implanted my body has changed tremendously from brain fog, GI issues with severe bloating. I suffered from extreme fatigue, and my joints were swollen, especially my right knee. Link. (Unknown if it is Mentor saline or silicone). Trying to get original doctor surgeon to release my medical records. Dry hair, dry skin, dry mouth, and dry nails. Link. Mentor implant recalls, unlike other recalls, may require multiple doctor's visits and even surgery. Link. Painful joints (most hands, knees, hips, shoulders) bone pain swelling of hands, tight skin. I had mentor cohesive gel implants placed. Ive been to the doctor many times complaining about the lymph gland being swollen and getting dismissed repeatedly, i could really use to use some advice or support. At this point, it had been about 9 months of sustained acute illness. The surgery was on a thursday morning, and i needed a wheelchair by this time. Please take these off the market. I was shocked as nothing like this was ever heard of in my family. Additional complications are also covered for 10 years with free product replacement. Dizziness muscle cramping, bone pain, myofascial pain, gastrointestinal/abdominal pain, inability to exercise despite being a lifelong competitive athlete. Bad gastrointestinal and digestive issues, nausea, intense night sweats and hot flashes, poor sleep and insomnia, anxiety and depression. 4. Most of the missing silicone was never accounted for, though. i no longer had shortness of breath. I explanted 3 weeks ago and all my pain is gone. it looks like thats what i am coughing up sometimes like i said its extremely sticky. April 2013. Something needs to happen you have dropped the ball on this. Patient was diagnosed with left implant rupture around (b)(6) 2015 and got implant removed on (b)(6) 2015. Hypothyroid, coughing, intolerant to heat and cold, new and persistent viral infections, candida, constant yeast infections. My medical bills and trips to hospitals are out of control. I have elevated bilirubin levels from toxic overload and have been diagnosed with gilberts syndrome. Learn how. Implants placed under a mentor trial in 2004, in 2005 i had revision surgery all the right implant capsulized within six months. Link. Then depression and daily anxiety became an issue. Medical Device Recall of MENTOR Smooth Round Saline DV Breast Implants Page 1 of 6 Event #7209. Link. This study wasto be conducted in Denmark, Germany, and the UK. Copyright 2016-2022 BreastImplantIllness.com. Thoroughly screened blood tests, mri, ctscan, ultrasound, endoscopy and colonoscopy. Thank you for the many experiences posted. Cultures were done, idc was called in and i had pseudomonas aeruginosa and serratia marcescens. Patient was scheduled to have mri exam later. The site is secure. I have chronic candida overgrowth hormone fluctuations, chronic fatigue, various gut issues, digestion problems. Manufacturer Reason. It was unknown whether cd30 positive or alk negative. To be able to walk and have energy again, and hopefully for the arthritis symptoms to diminish. No patient information (name, phone number, email, date of birth) was provided, therefore no follow up was completed, and there is no additional information available. At the time year mark of getting implants, after being diagnosed with all of these issues, i saw multiple doctors and kept telling them i have a concern it was my implants making me sick. The patient reported to have several undisclosed illnesses within months of getting the implants put in. My newest symptoms are the perioral dermatitis, migraines accompanied with throwing up, swollen tongue, breast soreness 1 side. 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. Anyone who has received a Mentor breast implant should be aware of the product history and recalls. Six months after that surgery the left capsulized; however, surgery was not safe at the time. Link. Link. Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. Finally, the FDA released updated information on the status of breast implant manufacturer post-approval studies. Mentor MemoryGel (Premarket application number: P030053) (Approved November 2006) Description and Detailed Information Links: Mentor's MemoryGel Silicone-Filled Breast Implants have a. Link. In 2013, American Society of Plastic Surgeons (ASPS) commissioned a systematic literature review to be conducted by Tufts Center for Clinical Evidence Synthesis, funded by three breast implant sponsors, and the advisory board approved the final report on 8/1/2014. No further information was obtained. At least make every day doctors like rheumatologists aware that this is happening, and what can happen if they dont treat it right away. Immediately after removing the implants began seeing a new dr for help with this who after further lab studies diagnosed me with hashimotos thyroiditis which is an autoimmune disease more than likely caused by the endocrine disruptive toxins in the implants. They had migrated to under my arms!!!!! My implants were under warranty so mentor paid for a new set and most of the surgery. Link. Apparently mentor did not get the message about a ban on implants. I have had nothing but health problems since I got these in plants put in. I hurt everyday and have migraines. It took me that long to convince my doctor that something was wrong!!!! I lost 20lbs of muscle during this above-noted period, as my arm, leg and rear muscles atrophied, resulting in me being totally debilitated. %PDF-1.7 % FDA Recall. The implant packaging was opened and inspected on the sterile field table in the or. I am as active as i possibly can be, but lately it has become hard- i am always tired! I still have most symptoms, but many have improved at least slightly. 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. Her email is [emailprotected] and phone number is (301) 796-6134. I immediately felt relief in my joints and muscles as soon as they were removed. /f&b2jy|/ZS [=s Avoid delays that will only cause undue stress, worry, or possibly affect your health by using DoNotPay. Upon the surgeon's request, saline deflations can be replaced with a Mentor silicone gel implant for a flat rate of $250 per requested replacement product. I was hospitalized for rapid heart rate and low blood pressure. 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. 350-1640 Rushed to surgery for third time. 350-2225. Within 6 months of that time frame, i started to have medical concerns, which were unusual for me. Toxic shock symptoms, corrective tissue disease, vision issues, headaches, nose bleeds, recurring pneumonia. She became very ill and had been sick during a business trip, with a fever, swollen left breast and lymph node infection. Patient suffered pain on the left side for the past year and it was getting worse. 1-800-MENTOR8 (800-636-8678) Monday - Friday, 5:30 a.m. - 5:00 p.m. PST, excluding select holidays More than 10 numbers, contact manufacturer. Two weeks after getting great implants, lymph nodes began to swell and are still swollen. Updated silicone gel-filled breast implant rupture screening recommendations. I was in a car accident in 2014. 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. The implant was removed from the field and a new implant was used for the procedure. Link. Bilateral breast pain from breast implants. Unknown if it is Mentor saline or silicone: Mastitis, swelling, nodules and varius other illness. Feet red swollen to deformity. I am having a had reaction to my mentor silicone memory gel implants that were placed under the muscle three years ago. Extreme hair loss that has created balding (alopecia) on my scalp. Link. Mentor MemoryGel Silicone Breast Implants: Scroll down for a list of symptoms women have reported to the FDA and for reports of mastectomy and reconstruction cases, fungus, body parts removed, manufacturer issues, BIA-ALCL, other cancers, and pre and post approval study follow-up. MemoryGel breast implants come in either a textured or smooth surface shell and are available in a wide range of sizes and profiles to fit your body. I was a very healthy, active person up until all of this happened. Since the removal of the implants, i have had 2 addl reconstruction surgeries including a latissimus flap. Another said i was an interesting case as tests for memory mostly showed fairly bad short term memory. I am researching that option now. I have gone through all my savings trying to get better! Also. SQ*ONlG7[Gqt9`)/kKJ`%KP\gmht(1IsNeX|J-J|beLYh7uq&%#y6i/UsBA{GxZB5-8nWW!A`y]4M6AbQb&'g*-i!czb@68CsbD6UHpVq hx/Mebx- s. Had breast augmentation in (b)(6) 2013. The product was a silicone gel breast implant. Silicone implants causing symptoms such as weakness, as if something is sucking the life out of me, low thyroid, low wbc count, intense joint and muscle pain. However i had in 2010 began to be diagnosed with many more autoimmune disorders. Link. Lowered immune system, and i get sick (strep throat, colds) and i never used to, slow clearing of colds. I also developed tingling and pain in my hands and itchy pains and a numb right thumb. During a bilateral breast augmentation, the implant that was to be used for the right breast was discovered to have/contain foreign material. Per the customer, the plastic wrapping the implant boxes was also damaged. The plastic surgeon performed what is called a dual-plane approach half under/half over the muscle to give a tear drop shape). I have 3 children and im extremely scared that im going to die from this illness. Metalic taste in my mouth. For Additional Information Contact. I have many chronic illnesses that i never had before including: pain in my breasts, joints, bones, arthritis, migraine headaches and dizziness, aversion to smells and taste, dry skin, canker sores in mouth, throat and swallowing problems, chronic fatigue, memory problems, gerd, insomnia, ear ringing, restless leg syndrome, forgetfulness, anxiety and panic attacks, swelling, inflammation all over body, weight gain in upper extremities. I had a 3-d mammogram and everything looked fine. I know many women do whether they have had autoimmune illness before or not! 350-2275 Weekly b12 injections. Epidurals and physical therapy for years. The patient sought treatment from several physicians, who concluded that the implants were responsible for patients condition. I had upper back and neck weakness. On the date listed above, i received breast augmentation with mentor smooth round high profile gel (silicone) implanted ref (b)(4), left lot #6528127, sn # (b)(4) and right lot #5950089, sn # (b)(4). (Unknown if it is Mentor saline or silicone). The implanting surgeon ran a suture through the implant when placing them, they began leaking soon after placement. Released and left breast began to swell, i ran a fever, chills, severe headache behind my eyes, nausea, fever. f5/@aGp/)gd 3Li"'7eXqZ')n'4q`_;*Wa$.D&?HW/ SB( a|jg!Fqm. 1* Choose from a wide range of sizes and profiles including Moderate Classic, Moderate Plus, High, and Ultra High. Surgery lasted longer than expected due to the difficulty of removing the silicone. She had hashimotos disease, chronic fatigue, brain fog, possible alcl according to the physician. The following section provides links to the approved labeling and the progress of expected labeling supplements. I believe since i already had autoimmune disorders i should have never had silicone implants. It is unknown where and how the issue occurred. The new labeling approved on October 27, 2021 follows from the labeling recommendations described in the FDAs September 2020 guidance. Mentor Textured Silicone Implants. I have been extremely sick about 1 year after surgery. 7. I had silicone implants put in (b)(6) 2014 and by (b)(6) 2015, i was getting sick. Patient advised that she had not selected an explant surgeon or explant surgery date as of yet. I do not smoke cigarettes, and rarely ever drink any alcohol. 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. Weight began to plummet, as did blood pressure and just all over general malaise. The patient believes that the discoloration is a fungus growth inside the right device. I continue to have swelling in my hands and weakness in my upper arms, neck and back. Difficulty sleeping, difficulty recalling words (mixing up words), short term memory issues. I come from a long line of healthy people who mostly live into their nineties. Link. Updated labeling to communicate long-term study results is pending for all implants in this table. Extreme smell sensitivity and intolerance of foods i used to eat. Smooth surfaced implants are not affected by. Mentor is commited to product safety. Mentor made a decision to file a fda medwatch report based on the above information; however, currently, there is no solid evidence in the literature to suggest that breast implant rupture alter the risk of breast malignancies. Then upon investigating, i found that all of my symptoms were related to silicone poisoning due to ruptured implants. I am only (b)(6) and should not have any of these health issues. I also have become intolerant to smells and chemicals. Device description with a list of specific materials in the device. Research needs to be done. I have had recurrent bacterial vaginosis, utis, black-ish green discharge form breast nipples (tested and came back as staph infection). I have mentor breast implants that were placed in (b)(6)2007. Told me to go to (b)(46 clinic. Two major issues, deformity and a rare autoimmune disease seen in much older adults. I have learned that the mentor company product was approved but was supposed to complete a 10 year study that has now been cancelled. The patient has no family or personal history of breast cancer before this diagnosis. endstream endobj 311 0 obj <>stream The .gov means its official.Federal government websites often end in .gov or .mil. This question is for testing whether or not you are a human visitor and to prevent automated spam submissions. After approximately 1. Fast--You don't have to spend hours trying to solve the issue, Easy--You don't have to struggle to fill out tedious forms or keep track of all the steps involved in solving your problem, Successful--You can rest assured knowing we'll make the best case for you. In 2017, i chose to have implants removed. Severe pain in feet. 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. Rheumatoid arthritis sjogrens barretts esophagus with hiatal hernia achalasia, hypertensive les graves disease, severe brain god, severe back pain and behind my left breast, and the worst one of all is this yuck that is trapped in my throat that many women from the breast implant illness site seem to have but mine is extreme i cough up lots of mucus and its debilitating. 350-1645 First, the FDA issued orders restricting the sale and distribution of breast implants to help ensure that patients considering breast implants are provided with adequate risk information so that they can make fully informed decisions. I did not smoke, do not use drugs, do not consume alcohol and eat very clean. 800-235-5731. 350-2375 It is related to my breast implants in my opinion. The shell is filled with MemoryGel, Mentor's proprietary formulation of silicone. Had breast augmentation done. Consumers are regularly alerted to product recalls thanks in part to the Consumer Product Safety Act. Palpitations. Ringing in ears, metalic taste in mouth, skin rashes bug bites, scratches and other wounds take forever to heal. Any ideas what this is? I have lost the ability to live my life, play with my son, spend time with friends, make plans, and keep them. I have been ill since having silicone implants fibromyalgia, sleep disorder, pain in neck, shoulders, hips, legs, feet, and back. Mentor Memory Gel Implants. Developed anxiety and uncontrolled vaso-vagal responses. (Unknown if it is Mentor saline or silicone). What is your recommendation? I started to have rapidly degenerating joints and have had 5 ortho surgeries including joint replacements. Muscle pains and joints. Contact the relevant medical authorities who conducted the surgery and request an updated Mentor breast implant recall information. I got severe spinning vertigo that lasted 6 years. It was reported that a (b)(6) year-old female underwent primary augmentation surgery using mentor silicone implants. 304 0 obj <> endobj The sale and distribution of Mentor Breast Implant Devices are restricted to users and/or user facilities that provide information to patients about the risks and benefits of the device prior to its use in the form and . Link. 350-3310 hXmo7+br@/M`I8]pqa#yb;7`FERH=:Z+3)5Ii-2ZLyA The changes i have had in my body in the past 15 months have been so drastic for me. I had to have a double mastectomy in 2009 with immediate breast implants.