For the past several years i have had many health issues from fatigue to swollen lymph nodes that will not go away, and a lot of things in between. 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. Besides seeing my primary care physician, i have seen a neurologist, rheumatologist, holistic/functional medicine, gynecologist, dermatologist, psychiatrist, therapist, chiropractor and have tried massage therapy, acupuncture, sauna, and more recently i saw a doctor at (b)(6) for heavy metal issues. There may also be a variety of associated costs. It was unknown whether cd30 positive or alk negative. I come from a long line of healthy people who mostly live into their nineties. The FDA issued final guidance, Breast Implants - Certain Labeling Recommendations to Improve Patient Communication in September 2020. Released from hospital after 5 days. The fatigue is devastating. Had breast augmentation done. 2 It was reported that (b)(6) the female patient underwent primary breast augmentation surgery using mentor gel implants in 2000. Link. This event was reported via # medwatch (mw5032276). No contact information was provided in mw report, therefore no further information has been made available. I fortunately found a (b)(6) support group for women with breast implant illness, what i believed to have. I have had blood tests urine testing, ct scans, mris, and neurological testing. Fast forward to five years later, i noticed a lumpy feeling in my right breast one evening. This past year has been the worst so far and i just explanted without replacing the implants because i am 100% certain they have been poisoning me and i am disgusted how the medical industry does not take these type of complaints seriously. . Shortly after, i began to experience a myriad of unexplained symptoms including anxiety, thyroid levels off, debilitating fatigue, dry eyes, blurred vision, brain fog, dizziness, etc. Eventually by 2007 both implants were capsulized. Immediately, my breathing was cured! Irvine, Calif., (January 13, 2021) - Mentor Worldwide LLC, the number one global brand in breast aesthetics, and part of the Johnson & Johnson Medical Devices Companies** today announced that the U.S. Food and Drug Administration (FDA) approved the MENTOR MemoryGel BOOST Breast Implant for breast augmentation in women at least 22 years . 5. I have experienced fatigue, joint pain (hips), muscle soreness, red and sore eyes, weight gain, inability to take deep breaths, inability to lose weight , double vision and trouble recalling words. Link. The hospital has denied the mammogram caused the rupture but both at the same time is so obvious. I believe as i stated before they have exacerbated my autoimmune challenges. I researched and found tan excellent plastic surgeon. Link. Manufacturer Mentor Texas, LP. I have been extremely sick about 1 year after surgery. 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. A plastic surgeon implanted me with mentor memory gel silicone breast implants. Anyone who has received a Mentor breast implant should be aware of the product history and recalls. Hugs hurt. Mentor is commited to product safety. Last night I already started the ball rolling to see an EN BLOC explant removal expert surgeon closest to me and by the grace and mercy of God i found one! Even though i was under a trial study, mentor never contacted me and i dont think the surgeon reported as per the agreement i signed. It was reported that a patient alleged autoimmune-like symptoms after using mentor memory gel implants. I explanted the implants on (b)(6) 2017 and shortly after, developed a hematoma (in the area the silicone had to be scraped away from around my collar bone) which burst, leading to a second surgery. My doctor said there is nothing that can be done to prevent or fix the deformity once the implants are removed. Some of the symptoms are, joint pain, muscle pain, blurry vision, ringing in the ears, hair loss, ibs, chronic fatigue, memory loss. Sit back and relax while we do the work. This somewhat lessened some of my symptoms but i still felt sick like i was dying slowly. I had silicone breast implants and had no idea they both got ruptured. I have that as well I never thought about any of my issues (lots) having anything to do with my implants in 2017 I would definitely think about taking them out to NOT have the issues / pain Ive dealt with this long. Since that day ive suffered the following abnormal weight gain, chronic fatigue, brain fog, diagnosed thrush, lack of energy, dry eyes, lack of concentration, dizziness, inflammation, dry skin and hair, estrogen imbalance. Link. Wrong! In a matter of 48 hours one breast swelled and i went to see my plastic surgeon. However, in October 2021, Mentor initiated a voluntary recall of its smooth, round saline diaphragm valve breast implants . I was able to return to a mostly normal life, although the symptoms never went away. Plastic surgeon does not know if or when surgical correction can take place. We began to wonder if my illness could have something to do with my implants. Swollen hands, tingling in the hands and arms when i bend my joints. I was diagnosed with alcl in 2016. Team of doctors at (b)(6) clinic couldnt figure out what was happening to me. I experienced horrific pain, consulted with pcp who ordered x-rays that showed no rupture. By this time, too, i began feeling malaise, and i then was weakened to the point of being unable to walk unaided. PMAs with Product Code = FTR and Original Applicant = MENTOR CORP. Link. Over time since implants. 350-1625 they have slowly been poisoning my body. of Irving Texas initiated a recall of their MemoryGel breast implants on July 01, 2016, due to a labeling mix-up, Consignees were notified by mail and a follow-up visit by a sales representative, Hardening of the breast or area around implants, Pain, tenderness, swelling, burning, or numbness. Link. Here are all the ongoing symptoms: migraines, anxiety, fatigue, temperature intolerance, sensitivity to smells, burning pain in breasts, inflammation in breasts, weakness, chronic back pain, whole body dryness, pigment discoloration, blurred vision, word retrieval, concentration, and rapid weight gain. I was extremely healthy at time of the implant surgery and was told these were fda approved and very safe. My body couldnt sweat couldnt get rid of toxins. I could not raise my arms, move my legs or use my hands. Before sharing sensitive information, make sure you're on a federal government site. I had follow-ups with my surgeon and everything seemed to be fine but the symptoms continue to become worse and more frequent. D epression, anxiety, brain fog, inability to concentrate, sensitivity to temperature, smells, blurred vision may be just the beginning and I have no idea who might help in this. hb```l@(0>.JO;%.mP'cGGE[GCKGGG>aS4FeX#aD{9L'0baZ\C@Ib @w?Vf . Please help me before i lose my life. This has been a terrible month and year for me. Link. At this point, it had been about 9 months of sustained acute illness. 800-235-5731. I did not get well after the surgery, although he was able to take out 130 ccs of material on one side and 210 ccs on the other. After approximately 1. Multiple attempts have been made to obtain clarification on catalog, lot number and manufacture site of the devices that were used during this procedure. I was acutely ill for several months, until the physician who had ordered the mammogram phoned me that something was peculiar on the mammogram film. Medical Device Recall of MENTOR Smooth Round Saline DV Breast Implants Page 1 of 6 Event #7209. They also recommended ultrasound at the discretion of the radiologist. She became very ill and had been sick during a business trip, with a fever, swollen left breast and lymph node infection. Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. I feel my breasts are ruined forever now. r2c=nf"{*!5;/[{8F7)/Z}}o_=T*u 4+ )Z9B There was no patient contact reported. Released and left breast began to swell, i ran a fever, chills, severe headache behind my eyes, nausea, fever. 350-2325 The patient sought treatment from several physicians, who concluded that the implants were responsible for patients condition. Recent study shows patients and surgeons both preferred the MENTOR MemoryGel BOOST Breast Implant as feeling more like a natural breast versus another leading brand. As of today, (b)(6) 2017, im taking cipro 500 mg twice daily, drain is still intact, takes me over 2 hours to bathe, dry my hair and dress, because im fatigued. Brain fog, anxiety, depression, numbness, sore, fatigue, loss of ability. Rheumatologist said i am at high risk for lymphoma. I was hospitalized for rapid heart rate and low blood pressure. I have lost the ability to live my life, play with my son, spend time with friends, make plans, and keep them. I started becoming ill after a few months. FDA Determined. In (b)(6) 2016, the patient underwent surgery and the mentor memory gel implants were removed. I am researching that option now. They were smooth, round, and saline, 270 on one side and 300 on the other. Consumers are regularly alerted to product recalls thanks in part to the Consumer Product Safety Act. Hair thinning and lost. Yet, when i seek the care of specialists, few are able to set a solid diagnosis and i also received clashing diagnosis when seeking second opinions. No deflation were found on both devices. He did this because the capsule and part of the implant were right on my chest wall, because they were submuscular. ], YOgq |2`k''S>L*4'SwxWb^Q(*:P~4}C{e*@6nh(,gey84,px|(JI,C-.k hgt0LIUK~wcHP~YU=Kg2wKE|ytZ$8 I did not correlate the breast implants till approx (b)(6). Once left breast was opened, implant was ruptured and silicone had settled into the fascia going completely underneath my arm pit and almost to my back. Reoccurring infection like uti, bv that are persistent and often do not go away with one round of antibiotics, and bladder pain. Link. On (b)(6) 2016 she underwent revision operation due to breast implant leak. For the most part I'm pleased with how they look but unfortunately I'm having the implants removed in two weeks due to autoimmune reactions to them. I continue to have swelling in my hands and weakness in my upper arms, neck and back. 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. My medical bills and trips to hospitals are out of control. 10. I noticed it has a Ribble in it, and it has a bubble, the bubble caves in when touched. * In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients. 350-3330 Mentor textured silicone gel implants. I continue with occupational therapy sessions. I do not smoke cigarettes, and rarely ever drink any alcohol. Auto immune disease, hands were swollen, red, and itchy. Around 2005, i started having raynauds disease which always affects my nipple and toes when cold. I have chronic candida overgrowth hormone fluctuations, chronic fatigue, various gut issues, digestion problems. It started with pain, fatigue, numbness, concentration, and memory loss, which has now triggered an autoimmune response and high levels of toxicity in my body. 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. A lower risk of complication is rupture. Breast pain near site of implants was dismissed and then appeased by suggestion to take both vitamin e and evening primrose oils (neither helped reduce pain/discomfort). Mastectomy reconstruction revision for deformed reconstructed left breast. Device description with a list of specific materials in the device. 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. Link. If you purchased the item online, enter your transaction details and payment method as well. The shell is filled with MemoryGel , Mentor's proprietary formulation of medical grade silicone gel, and is constructed of successive cross-linked layers of silicone elastomer. Test (unk) dates but will get. 350-2275. 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. Per patient, the physician woke her up in the middle of the procedure informing her of the discoloration and asked her if he could replace them, therefore the patient underwent bilateral replacement. I am tired all the time despite excellent diet and plenty of exercise. Link. Patient also had developed rashes and pruritis. Mentors failure to address these concerns and comply with its post-approval study requirements is a violation of the firms pre-market approval order., FDAs warning letter to Mentor Worldwide LLC (Mentor). 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. Within the past 8 months i heard about breast implant illness, i do believe i suffer from it. Spent a lot of money only to learn my implants made me sick i was diagnosed with fibromyalgia and hashimotos along with just guesses of what could be wrong. Difficulty sleeping, difficulty recalling words (mixing up words), short term memory issues. Tell us about your purchase, including the product name, brand, store you purchased the item from, price, and date of purchase. I eventually had to remove the left fallopian tube and both ovaries due to the severe pain. Mentor Worldwide, LLC. Link. The affected consignees were notified via customer letter on 7/1/16, and a follow-up with respective sales representative via visit. (Unknown if it is Mentor saline or silicone). Surgery lasted longer than expected due to the difficulty of removing the silicone. The products included in the recall are: So i am reporting my situation. Approx 7 years ago, i had a breast augmentation done, re-done actually. There is no specific information regarding any diagnoses or symptoms. Cold feet, swollen tongue, sore breast, migraines/throw up, perioral dermitis, weight gain. Panic attacks, chest pain, breast pain, inflammation, depression. I even developed (b)(6) 3 weeks after the surgery under my armpit, which ive never had. Smooth surfaced implants are not affected by. 12. Complex case, a lot going on and they couldnt treat me successfully. In (b)(6) 2014, both ruptured implants, damaged lymph nodes, affected chest muscle, and surrounding tissue (to my chest wall) were removed during a 7 hour surgery. Link. At this point, though, i really just want to feel healthy again and get these toxic bags out!. The packaging appeared to have pinholes or bites, as well as black dots that could have been bug droppings. Patient was scheduled to have mri exam later. Now i have white-ish pus discharge (fungal infection), extreme pain/burning in both breasts as well as numbness/tingling/burning sensation in arms/shoulder, grade #4 capsular, contracture, trouble breathing properly, memory loss/brain fog, blurry vision, swollen throat lymph nodes, loss of motion in both arms, major teeth issues due to implants, leaky gut/ibs, extreme anxiety and depression, bed ridden, muscle pain, unknown opage spots on breast ultrasound, candida issues/fungal issues/bacterial issues, muscle loss, extremely achy joints, massive fatigue, sinus issues, migraines. I know it was the implants pushing on my chest, probably due to the capsular contraction. Sudden decline in health and increase in pain of area of implants as well as systemically. Per the customer, the plastic wrapping the implant boxes was also damaged. Link. But since the surgery i feel like my lymph nodes are constantly swollen and keep struggling to fight off infections and colds. Patient also had delayed wound healing, infection, lymphadenopathy on the left side. Breast tissue was not sent for histology at that time. I started to have rapidly degenerating joints and have had 5 ortho surgeries including joint replacements. I was a 34 B previously. At least make every day doctors like rheumatologists aware that this is happening, and what can happen if they dont treat it right away. What is your recommendation? It was reported that a (b)(6) female patient underwent breast augmentation revision with mentor gel device on (b)(6) 2011. The recall came after the FDA released data in 2019. My situation was as such: in (b)(6) 2015 after being diagnosed with ductal carcinoma in situ (dcis) for a third time in 12 years, i had a mastectomy with immediate reconstruction on my right side, with a mentor gel-filled implant. I was sent home and within 2 days i began hemorrhaging from left breast. I started having serious difficulty breathing at all times, and especially when laying down at night. Trying to get original doctor surgeon to release my medical records. All i want is for my original breasts to look normal and not have the muscle flex deformity. 0 Vitamin deficiency and i take weekly high dosages of vitamin d (50,000) and daily vit d (8,000) and im barely in the normal range. I had informed the technician that i had them. %PDF-1.7 % More research needs to be done and patients need to be warned of other medical harm that can happen because of the silicone implants. I also developed severe reactions to some foods. endstream endobj 310 0 obj <>stream How the Product Recall Claims product works: And that's it! It is quite difficult to believe that the mentor gel-filled implant was leeching or bleeding toxins into my body to the extent that i was totally debilitated for over 10 months of my life. Link. A lot of my symptoms have improved or disappeared after removing the implants. MentorMemoryShape, MemoryGel, and Memory Gel BOOST implants are recommended for augmentation patients who are at least 22 years old, while the saline breast implants are indicated for patients who are 18 years and older. It behave with extreme fatigue and has increasingly gotten worse. Here are some examples of our many recall request assistance programs. The plastic surgeon at (b)(6), removed the implant material by opening up what was left of the capsules rather than using the en bloc method, which is now standard. Do your research ladies, get a $$ loan if you have to, your health is worth it! I finally found out that this is the brand I have for about 10 years nowI just thought I was having symptoms of getting old, until I heard about BII.now I realize that every thing that is wrong with me I have read about on BII sites..Now, what do I do? (Unknown if it is Mentor saline or silicone). (Unknown if it is Mentor saline or silicone). Then upon investigating, i found that all of my symptoms were related to silicone poisoning due to ruptured implants. Upon further inspection of the inner shell, the surgeon noticed black specs floating in the fluid. (Unknown if it is Mentor saline or silicone). The patient has no family or personal history of breast cancer before this diagnosis. I had an mri and confirmed i had ruptured my implant. For Additional Information Contact. Mri confirmed that the breast implant had ruptured. After doing research on my own and some common sense. 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. 2 years post. (Unknown if it is Mentor saline or silicone). I felt like i was dying. These devices are not safe. The reoperation incidence for primary augmentation and primary reconstruction was 19.4 and 33.9%, respectively, with explantation and replacement with a study device in 3.9% of primary augmentations and 10.4% of primary reconstructions. I had mentor silicone breast implants in (b)(6) 2007. (catalog # 350-7300bc, serial number left side (b)(4) and serial number right side (b)(4)). **1 y* Link. The new labeling approved on October 27, 2021 follows from the labeling recommendations described in the FDAs September 2020 guidance. I have been on a decline in my health since i had implants placed over the muscle in 2000. 350-2325. 10. I dont even know how to put it in words. It helped the pain a bit. I would not recommend implants to anyone. Link. 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. Previous to implants i was on medication for thyroid issues, but nothing else and was in very good health. Mentor reports this event with an abundance of caution. Updated labeling to communicate long-term study results is pending for all implants in this table. endstream endobj 311 0 obj <>stream We have helped over 300,000 people with their problems. Chronic pain, chronic fatigue, cognitive dysfunction (brain fog, difficulty concentrating, word retrieval, memory loss, difficulty processing information), muscle aches, pains, and general weakness, joint pain, dry itchy eyes, easy bruising, loss of sex drive, inability to sexually perform, shortness of breath, night sweats, hormonal imbalances, tingling and numbness in arms, hands and fingers, cold hands and feet, metallic taste in mouth, nail cracking, splitting, no growth, skin freckling, increase in papules, edema, decline in vision, digestive and gastric issues, throat clearing, difficulty swallowing and choking feeling, anxiety, depression, panic attacks. Since I had them implanted my body has changed tremendously from brain fog, GI issues with severe bloating. I have hot and cold sensitivities. These are not safe. I have arthritis and thyroid issues. 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. Mastitis, cellulitis of the breast. Right implant capsulated and became painful. The patient did not report any other symptoms and did not want to return the devices back for failure analysis. Seven years ago i went from my lovely, natural b-cup to silicone (mentor memory gel) d-cup breasts. 2 No improvement with nsaids (multiple tried). (Unknown if it is Mentor saline or silicone). 304 0 obj <> endobj From that time on, i developed more and more symptoms that piled on top of each other. 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