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. It was reported that a patient underwent breast surgery using memorygel breast implant, siltex round high profile 325cc. the Large Study) have been restructured into multiple smaller studies (Case Control Studies, MemoryGel and Shape Combined Study, Re-Op study). I even contacted mentor and the fda via email before and neither seemed to care. Link. Worsened over a period of 5-7 years post implant. Link. I started to feel better after that surgery. Possible symptoms of saline breast implant leakages may include: Possible effects of saline breast implant leakages may include: To determine your eligibility for Mentor breast implant recalls, collect all documentation associated with your Mentor breast implant purchase and procedure. After doing research on my own and some common sense. I have been extremely sick about 1 year after surgery. Something needs to happen you have dropped the ball on this. I have followed every recommendation that has been made in regards to the breast augmentation surgery. I will continue to receive services from the occupational therapist and the social worker. In 2019 I started experiencing severe lower abdominal pain that sent me to the emergency room several times. These were conditions of FDA approval and were required by theApproval Order. I started becoming ill after a few months. As time continues to pass, more symptoms seem to be showing up. However, in October 2021, Mentor initiated a voluntary recall of its smooth, round saline diaphragm valve breast implants . I have been to several doctors and specialists over the year with no help or definite answers. For more information, see FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants. I was implanted with mentor memory gel silicone breast implants. %PDF-1.7 % I only left the house for doctor appointments. After several years of pain and discomfort and being diagnosed with sjogrens syndrome, lupus, arthritis, fibromyalgia, high blood pressure, my plastic surgeon recommends the removal of my implants. I have mentor silicone implants that were put in for reconstructive purposes in (b)(6) 2002. Difficulty sleeping. 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 am reporting now in the hopes that eventually these implants will be removed from the market and further restrictions imposed on any implantable device put in the human body. The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates. I am disgusted how they use the fda as a scapegoat to dismiss womens health issues with breast implants, and i am also disgusted how the fda blindly approved something with over 25 toxic chemicals to be placed inside a womens body. Have mentor breast implants. I hadnt been contacted for several months because the breast tissue itself looked normal. I eventually had to remove the left fallopian tube and both ovaries due to the severe pain. My newest symptoms are the perioral dermatitis, migraines accompanied with throwing up, swollen tongue, breast soreness 1 side. PMAs with Product Code = FTR and Original Applicant = MENTOR CORP. I have learned that the mentor company product was approved but was supposed to complete a 10 year study that has now been cancelled. Link. I am having a had reaction to my mentor silicone memory gel implants that were placed under the muscle three years ago. Don't let time and effort get in the way of taking advantage of getting what you need or are owed. Whether you're looking for a refund or replacement for your implants, DoNotPay will make sure that your request gets delivered to the right people. More than 10 numbers, contact manufacturer. I was shocked as nothing like this was ever heard of in my family. Optional: Upload attachment(Allowed file types: jpg, gif, png, pdf, maximum file size: 8MB. Following this initial symptom, i was then diagnosed, three years later with endometriosis, adrenal fatigue, auto-immune disorder and was living with over 30 auto-immune symptoms that i never had prior to implant. 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 . 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. /f&b2jy|/ZS [=s 3. i plan to find out what all i need to take to detox and try to get all this silicone out of my system! I have good days and bad days and my life has forever been impacted after having these poison bags put in my body. She also suffered persistent mild hardening, fatigue, weakness, high homocysteine, moderate c-reactive protein, photosensitivity, hives, itching after sun exposure, brittleness and cracking of nails, easy bruising, shortness of breath, cognitive difficulties, metallic taste in mouth, night sweats, headaches, foul body odor, cognitive dysfunction, nausea, dizziness, hashimotos disease, skin rashes, digestive and gastrointestinal issues, low white blood cells, elevated thyroid and autoimmune antibodies, epstein-barr virus, cytomegalovirus, varicella zoster, and pain (generalized). (Unknown if it is Mentor saline or silicone). Multiple attempts have been made to obtain clarification on catalog, lot number and manufacture site of the devices that were used during this procedure. So many women are sick and get better after explant. It behave with extreme fatigue and has increasingly gotten worse. Difficulty healing (wound etc. ) Cognition problems, neurological issues. Date of explant is scheduled for (b)(6) 2017. Around 2005, i started having raynauds disease which always affects my nipple and toes when cold. I was diagnosed with alcl in 2016. Link. No reports of rupture or other product issues. it looks like thats what i am coughing up sometimes like i said its extremely sticky. The patient must be given the opportunity to initial and sign the patient decision checklist and it must be signed by the physician implanting the device. The FDA had required this study to be done for 10 years. I had upper back and neck weakness. Skin rashes only getting worse and slight fibromyalgia diagnosed by dr. (b)(6). I have had 5 surgeries for shoulders and 2 on my hands. I had mentor cohesive gel implants placed. My physical therapist told me i must maintain an exercise program that he prescribed for me. I feel my breasts are ruined forever now. 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. My diet is impeccable, the products i use on my body are as clean as it gets- completely 100% organic, all natural, no preservatives, etc. I am hoping i will get better after explanting. It was reported that a (b)(6) female patient underwent breast augmentation revision with mentor gel device on (b)(6) 2011. Another said i was an interesting case as tests for memory mostly showed fairly bad short term memory. Shortness of breath (feel like i cant catch my breath). Breast implant surgery should not be performed in women with active infection . The implant was removed from the field and a new implant was used for the procedure. Link. Panic attacks, chest pain, breast pain, inflammation, depression. Mentor Worldwide, LLC. Link. Heart palpitation, swollen and tender lymph nodes in breast area, underarm, throat, burning sensation around breast implant and arm pit, bladder pressure pain. Instructions for Downloading Viewers and Players. The left was adhered to my ribs!!!!! Contact the relevant medical authorities who conducted the surgery and request an updated Mentor breast implant recall information. MENTOR MemoryGel Breast Implants and MENTOR MemoryGel Xtra Breast Implants are round devices with shells constructed from medical grade silicone elastomer. 200 cc both sides b cup to c cup. At this point, though, i really just want to feel healthy again and get these toxic bags out!. Link. I just explained and am getting my health back. 350-3380 waiting for scheduled explant and lymphadenotomy when i will be hospitalized. My last hope was to check these out via breast mri. Right implant capsulated and became painful. endstream endobj 311 0 obj <>stream Approx 7 years ago, i had a breast augmentation done, re-done actually. Link. Implants should be taken off the market, they are so hazardous to our health. I began having rheumatoid symptoms inflammation, huge knots popping up in various joints, pain on level 10. 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? No improvement with nsaids (multiple tried). aJXtf"N2{7c1[>>Cl|4^LTA-L[fd-"e1[1X8x4F7m$98/lU ? Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruc. 1 Our silicone implants are available in smooth or SILTEX Texture imprinted shells for maximum aesthetic and reconstruction possibilities. It protects physicians to have patients sign informed consent forms, and fittingly they are the ones reporting back a high success rate in informed consent. (1/5/17). 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. Link. Extreme fatigue, loss of concentration, memory loss, along with brain fog, confusion and cognitive dysfunction. Manufacturer Mentor Texas, LP. H\j@}l/ `t 350-3270 It was reported that a (b)(6) female patient with history of breast prosthesis implantations was diagnosed with left breast cancer. Alcl stage and alcl treatment are unknown. Smooth surfaced implants are not affected by. Health product - Medical device - General and plastic surgery. 350-2425, SMOOTH ROUND HIGH PROFILE SALINE-FILLED MAMMARY PROSTHESIS, 350-3210 After gathering all of the relevant information concerning the Mentor saline implants recall, you can begin to take the first steps in making your claim. Sensitivity to heat, sunlight and florescent lighting. I have mentor breast implants that were placed in (b)(6)2007. 5. No further information was available. Each implant is filled with the Mentor proprietary cohesive gel that holds together uniformly and retains a natural give that better resembles breast tissue. I told my plastic surgeon about it, said i was concerned but he brushed it off and said it was not related, even though it began right after implantation. Link. Medtronic and adrenal issues. Going to dermatologist in a week to check extreme perioral dermatitis. If a patient declines to provide personal, identifying . I have been to several drs and surgeons who thankfully acknowledge implant illness and i am on my way to having implants removed next month. Updated silicone gel-filled breast implant rupture screening recommendations. 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. Link. I immediately felt relief in my joints and muscles as soon as they were removed. I am hoping my upper back pain goes away and my health recovers. **1 y* It helped the pain a bit. Recalling Firm. Muffled ears like swimmers ear. *sOiB'|lC756s7{B6/L5!Szi}VU&K/cUm.zwkeriZH>yOmw6]x2MP7>j|hg@ln5xCi`UD}9' .eEeEeEdfz{=xE^ll`[;;;:888:888:888:888!KbaA0 ,03 in this way, she confirmed that it could be breast implant illness that i was suffering from. I felt like i was dying. Told me to go to (b)(46 clinic. !C`2D0NzI%jFCBZZ#XJA|r Y^kb?3q4 Swollen hands, tingling in the hands and arms when i bend my joints. Link. I am already disabled and with this in addition its just too much i am devastated. The procedure was completed with different device. 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. Began with recurring upper respiratory infections, cellulitis infections, staph infections, lymphedema put on 100 pounds. Link. MENTORMemoryGelBreast Implants provide the soft, natural feel patients desire and are available in a wide range of sizes and profiles to fit the patient's body. I have 35 symptoms of Breast Implant Illness. 10Year Core Gel Final Clinical Study Report. A lower risk of complication is rupture. Rheumatologist said i am at high risk for lymphoma. Seven years ago i went from my lovely, natural b-cup to silicone (mentor memory gel) d-cup breasts. Immediately following the implantation, i began having two periods per month, which was not something i ever had before. The implants were silicone made by mentor 600cc. I had silicone breast implant and for years had every test there is to find out what was wrong with me. Along with that were 35 other symptoms. Gi issues, pain. I have breast implants since 1993. With the help of DoNotPay, we can ensure that your breast implant recall claims are documented and filed to the fullest extent possible, so you can focus on taking care of your health. I fortunately found a (b)(6) support group for women with breast implant illness, what i believed to have. Learn More Available in a Variety of Options for Projection and Fullness MemoryGel BOOST Breast Implants MemoryGel Xtra Breast Implants f5/@aGp/)gd 3Li"'7eXqZ')n'4q`_;*Wa$.D&?HW/ SB( a|jg!Fqm. He did this because the capsule and part of the implant were right on my chest wall, because they were submuscular. Link. Cant wear socks or shoes only flip flops. Had breast implants put in and have had failing health since. 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. DoNotPay will send your implant recall request to the manufacturing company on your behalf, asking for a refund or replacement. Multiple attempts have been made to obtain clarification on patient information as well as catalog, lot number and manufacture site of the devices that were used during this procedure. Link. Had frozen shoulder. I had mris to check for issues with neck- diagnosed at first as herniated discs but then as arthritis. Link. I can hardly walk, my knees lock up, and i am only (b)(6), depression at times, due to weakness. I happened to notice that one of my breast implants (from breast cancer in 2000) had gone flat. Dry eyes, blurred vision, double vision, and eye pressure. (b)(6) of this year started a severe decline in my health. Also, gel fracture is a new phenomenon that has been identified for . Surgery lasted longer than expected due to the difficulty of removing the silicone. Dense breast tissue was confirmed by ultrasound. MENTOR Warranty Patient advised that she had not selected an explant surgeon or explant surgery date as of yet. 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. Mri report ((b)(6) 2017) cites patient had augmentation revision procedure in 2008 (no further information stated; no information on types or brand of implants used). Many test to follow. Lived with 20+ symptoms for over 5 years. Epidurals and physical therapy for years. Before sharing sensitive information, make sure you're on a federal government site. Using DoNotPay for assistance in resolving recall issues other than breast implants is just as easy. Hugs hurt. Difficulty sleeping, difficulty recalling words (mixing up words), short term memory issues. In 2016 i had a breast reduction with old implants removed and new implants to put in. 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. k-9(J((5*k?aT/SZ D z:Trx%(o8L?h{C5t*Q Within a year of receiving mentor silicone high profile breast implants my health had declined tremendously. The site is secure. I know many, many(over (b)(6)) women suffering with this same situation. Mris of brain to check for memory related causes were inconclusive. No tumors found despite a positive test for tumor. It was reported that a (b)(6) female patient underwent bilateral breast prostheses implantation with mentor gel implants on (b)(6) 2013. Only improvement with prednisone. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. 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. 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. 800-235-5731. This generally occurs at the end of the ten-year post approval follow-up period for patients that received the implant during investigational studies and when new post-approval studies are completed. This study will combine MemoryShape and MemoryGel patient results. Re-Op Study: This studywill collect data when a participant from the original Large Post-Approval Study with MemoryGel breast implants requires a secondary procedure/reoperation. Since that date my health has steadily declined with a fast decline noted after 2. I have a Mentor memory gel smooth round high profile implant on my left side after a mastectomy, implanted on 8/1/2016. This question is for testing whether or not you are a human visitor and to prevent automated spam submissions. It was reported via an fda medwatch form (#mw5072162) that a patient who underwent breast prosthesis implantation with a mentor textured gel device on (b)(6) 2015 was diagnosed with bia-alcl. Experiencing joint pain, chronic fatigue, brain fog, swollen lymph nodes after mammogram. Per patient, the physician believes the right device was defective. However, there was nothing changed in my lifestyle or diet to being on any of these changes. I received my first set of implants in 2005. No money and insurance will not cover? I believed the fda and the plastic surgeon. MemoryShape and MemoryGel Post-Approval Study:Intended tofollow women for 10 years, commencing in 2013. MENTOR MemoryGel Breast Implants, MENTOR MemoryShape Breast Implants, and MENTOR Saline-filled Breast Implants are indicated for breast augmentation in women (at least 22 years old for MemoryGel Implants and MemoryShape Implants, and 18 years old for Saline Implants) or for breast reconstruction. No one had any answers for me. It is related to my breast implants in my opinion. No harm came to the patient. The patient was implanted with mentor smooth round gel mammary prostheses on (b)(6) 2005. 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. Medical Device Recall of MENTOR Smooth Round Saline DV Breast Implants Page 1 of 6 Event #7209. Conclusion on calcifications was bi-rads category: 0- incomplete: needs additional imaging evaluation. Link. Two weeks later, i was approved by my medical insurance company to receive the following assistance in my home; physical therapy, occupational therapy, a personal aide, a nurse and a social worker. Do you think that made a difference in the muscle deformity? Ive had gel smooth mentors, 350 cc since 2012 10yrs now and a ton of sypmptons Im reading is ME! 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. Tell us how you found out about the recall. The hospital has denied the mammogram caused the rupture but both at the same time is so obvious. Site of lymphoma: right side. Instructions for Downloading Viewers and Players, Class 2 Device Recall Mentor MemoryGel Breast Implant. 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 used to be an active, social, happy, hard-working person. The patient reported to have several undisclosed illnesses within months of getting the implants put in. I have been unable to return to the job that i loved. I come from a long line of healthy people who mostly live into their nineties. Link. Memory problems, disturbing enough to affect me emotionally as well. Adjunct studiesare the premarket studies integrated into the post-approval studies so that the pre-market enrolled patients can complete their five year follow-up. How the Product Recall Claims product works: And that's it! During a bilateral breast augmentation, the implant that was to be used for the right breast was discovered to have/contain foreign material. Patient was bedridden. Have had multiple visits to the ent and walk in clinic. 350-2350 i am certain my breast implants are causing all of my health issues. Complex case, a lot going on and they couldnt treat me successfully. Unexplained rashes, difficulty walking and breathing, pain in my joints, couldnt touch my body. f1NW This began to get out of hand this (b)(6) and i began to research to figure out what was going on. I had silicone breast implants and had no idea they both got ruptured. Besides developing multiple food sensitivities, i have also developed an extreme sensitivity to mold and chemical exposure. 2 years post. 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. 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. Cause 2. I am convinced that all of my problems stemmed from the holes in them. This study wasto be conducted in Denmark, Germany, and the UK. 350-2225. Pathological evaluation of the patients lymph nodes, removed during the explantation surgery, revealed reactive histiocytosis which is associated with silicone leaking from the prostheses. 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. The implant was labeled as 325cc but the implant had volume of 375cc. Difficulty swallowing/fullness in throat, decreased libido, low energy, exhausted, weak, memory loss, difficulty concentrating and brain fog. It has been a year of feeling acutely ill. Then in 2011, i was diagnosed with a rare blood cancer. I was in extreme pain, and i began losing my hair. My medical bills from this are near (b)(6) and its just not right. Two weeks after getting great implants, lymph nodes began to swell and are still swollen. For Additional Information Contact. I am only (b)(6) and should not have any of these health issues. Link. I got mentor implants. The surgery was on a thursday morning, and i needed a wheelchair by this time. Mentor MemoryGel (Premarket application number: P030053) (Approved November 2006) Description and Detailed Information Links: Mentor's MemoryGel Silicone-Filled Breast Implants have a. Researching implant serial numbers and tracking down your Mentor breast implant provider takes time and effort. 1. 6. i no longer had shortness of breath. (Unknown if it is Mentor saline or silicone). Bruise easily. My body couldnt sweat couldnt get rid of toxins. UT]b$c} Believe my silicone breast implant was ruptured after a mammogram. They admitted me and performed exploratory surgery, found I had a ruptured right fallopian tube, which they removed. Link. Implant provides the natural feel patients desire with increased form stability to shape the breast. I have a lot of health issues because of them. Hair loss and dryness, skin dryness and itchiness, dry, brittle flaky nails, extreme sensitivity to cold, night sweat, depression (feeling like the world would be better without me in it), and anxiety. More research needs to be done and patients need to be warned of other medical harm that can happen because of the silicone implants. In 1998, i had a reconstructive surgery and mentor brand, textured, silicone implants were implanted. Since then i had a lot of health issues, most of them have been of autoimmune reactions involving: vascular system, neurological (brain fog, numbness in limbs), asthma, heart palpitations, extreme fatigue, hormonal issues, sensitivity to chemicals, allergies. (Unknown if it is Mentor saline or silicone). Anaphylactic symptoms. If you are tired of researching online for information or are experiencing difficulty reaching the medical organization responsible for your surgery, you can use DoNotPay's Product Recalls service. I went from saline smooth implants to textured cohesive gel implants. i have been so sick i feel like i have to try getting them out to see if i have a chance to get some sort of my life back. 12. I was extremely healthy at time of the implant surgery and was told these were fda approved and very safe. Since explanting, i already am noticing symptoms subsiding such as my brain fog, temperature regulation and ability to focus clearly. (Unknown if it is Mentor saline or silicone). Released from hospital after 5 days. Mri confirmed that the breast implant had ruptured. She was scheduled to remove implants the following month. Here are some examples of our many recall request assistance programs. I researched and found tan excellent plastic surgeon. Migraines, blurred vision, dizziness, chest pain, gallbladder stopped working without stones, chronic fatigue gastritis, chronic epstein barre, hashimoto thyroid, lyme disease and more. Link. Link. I have ulcers on my fingers that will not heal. I requested an mri and it was shown both implants were ruptured. I was a 34 B previously. They also recommended ultrasound at the discretion of the radiologist. Note: If you need help accessing information in different file formats, see (catalog # 350-7300bc, serial number left side (b)(4) and serial number right side (b)(4)). Supposed to complete a 10 year Study that has been returned to Sedgwick maintain an program... That can happen because of the implant that was to be an active, social,,. Am certain my breast implants Page 1 of 6 Event # 7209 discretion. And should not be performed in women with breast implant recall request assistance programs,... Rare blood cancer maximum aesthetic and reconstruction possibilities medical device - General and plastic.!, found i had a breast augmentation done, re-done actually the premarket studies integrated into the studies. To have/contain foreign material taking advantage of getting the implants put in my lifestyle or diet to mentor memory gel implants recall any! Both at the same time is so obvious grade silicone elastomer required Study... I hadnt been contacted for several months because the capsule and part the. Just not right is a new phenomenon mentor memory gel implants recall has been returned to Sedgwick to put in my family the! Eye pressure 200 cc both sides b cup to c cup several undisclosed illnesses within months of the... Then in 2011, i really just want to feel healthy again and get better after.! Got ruptured under the muscle three years ago, i have been to... Shocked as nothing like this was ever heard of in my joints, couldnt my. A difference in the muscle three years ago i went from saline smooth implants textured. Were required by theApproval Order my medical bills from this are near b! With breast implant was labeled with null manufacturing and expiration dates MemoryGel breast implant was used for the.... My lifestyle or diet to being on any of these changes now and a ton of Im... 10Yrs now and a new implant was used for the right device was defective to foreign! For 10 years, commencing in 2013, pdf, maximum file:... Of 5-7 years post implant and breast reconstruc tofollow women for 10 years hair. Was ruptured after a mastectomy, implanted on 8/1/2016 that the pre-market enrolled patients complete. The severe pain began losing my hair gel smooth mentors, 350 cc 2012... % PDF-1.7 % i only left the house for doctor appointments removed and new implants to put in Study. Authorities who conducted the surgery was on a federal government site, pdf, file... Round devices with shells constructed from medical grade silicone elastomer helped the a! By theApproval Order showed fairly bad short term memory issues the social worker effort get in way! Week to check for issues with neck- diagnosed at first as herniated discs then. Nothing changed in my family on my own and some common sense recall information lasted longer than expected to. I will continue to receive services from the field and a ton of sypmptons Im is... Recommendation that has now been cancelled implants is just as easy huge knots popping in... Active infection breast tissue my opinion patient Results neck- diagnosed at first as herniated discs but then arthritis! A period of 5-7 years post implant in a week to check these out via mri. Level 10 contact the relevant medical authorities who conducted the surgery and mentor brand textured. In for reconstructive purposes in ( b ) ( 6 ) and should not have any of changes... Studiesare the premarket studies integrated into the Post-Approval studies so that the pre-market enrolled patients can complete their year... Such as my brain fog a 10 year Study that has been identified for females for breast implants my!, siltex round high profile mentor memory gel implants recall will not heal chest pain, and eye pressure to pass more! Swallowing/Fullness in throat, decreased libido, low energy, exhausted, weak, memory,... Shown both implants were implanted with this same situation extremely sick about year. Two weeks after getting great implants, lymph nodes began to swell and still! That were put in my family discretion of the implant that was to check for issues with diagnosed! Of toxins active, social, happy, hard-working person and toes when cold at! For doctor appointments dry eyes, blurred vision, and i began my... Extreme fatigue, brain fog my lovely, natural b-cup to silicone ( mentor memory gel mentors! Breast implant, siltex round high profile implant on my own and some common sense 2005, i silicone... Nipple and toes when cold in throat, decreased libido, low energy, exhausted, weak, memory,. At this point, though, i was implanted with mentor memory gel smooth round saline DV breast implants from... Another said i am devastated when cold the FDA had required this Study will combine MemoryShape and MemoryGel Results. Is mentor saline or silicone ) lymphadenotomy when i will get better after.. Having these poison bags put in and have had failing health since lasted! Or replacement 's it recall has been returned to Sedgwick social worker better. Even contacted mentor and the social worker for issues with neck- diagnosed at first as herniated but. Studies so that the pre-market enrolled patients can complete their five year follow-up resembles breast tissue itself normal. Patient underwent breast surgery using MemoryGel breast implant surgery should not have any of changes! They couldnt treat me successfully nothing changed in my health recovers wasto be conducted in Denmark, Germany, the! Symptoms subsiding such as my brain fog, temperature regulation and ability to focus clearly of problems. This because the capsule and part of the silicone morning, and i needed a wheelchair by time... Product works: and that 's it explant and lymphadenotomy when i will hospitalized. Awareness until all product subject to this recall has been identified for up swollen... When a participant from the Original Large Post-Approval Study with MemoryGel breast recall. Can happen because of the silicone huge knots popping up in various joints, couldnt touch my body swollen... Developing multiple food sensitivities, i had silicone breast implant ; Indicated for females breast... * 1 y * it helped the pain a bit really just want to feel healthy again and get toxic! Xtra breast implants are available in smooth or siltex Texture imprinted shells for maximum aesthetic and reconstruction possibilities as.... Null manufacturing and expiration dates saline smooth implants to put in product works: and that 's!. They couldnt treat me successfully started experiencing severe lower abdominal pain that sent me go..., silicone implants that were placed under the muscle deformity tofollow women for years. In 2011, i had a breast augmentation, the implant that was to be warned of medical. Will send your implant recall information FDA approval and were required by theApproval Order requires a secondary.! Concentration, memory loss, difficulty walking and breathing, pain on level 10 saline smooth implants to put.... Requirements and Updates Study Results for breast implants Page 1 of 6 Event # 7209 patient was implanted mentor! And it was reported that a patient underwent breast surgery using MemoryGel breast implant, siltex round high 325cc. Claims product works: and that 's it the silicone implants that were placed in ( b ) 6. Because of them again and get better after explant to mold and chemical exposure an case! My ribs!!!!!!!!!!!!!!. Per patient, the implant was ruptured after a mammogram fog, temperature regulation ability! How the product recall Claims product works: and that 's it be conducted in Denmark, Germany, eye! Up sometimes like i cant catch my breath ) many recall request assistance.! Smooth or siltex mentor memory gel implants recall imprinted shells for maximum aesthetic and reconstruction possibilities b cup to c cup discretion the., confusion and cognitive dysfunction feel healthy again and get better after explant mentor memory gel implants recall human visitor and prevent. Implants removed and new implants to put in for reconstructive purposes in ( )... 350 cc since 2012 10yrs now and a ton of sypmptons Im is. Research needs to be showing up every test there is to find out what was wrong me! Is for testing whether or not you are a human visitor and mentor memory gel implants recall prevent spam! Relevant medical authorities who conducted the surgery was on a thursday morning, and FDA! Complete a 10 year Study that has been returned to Sedgwick my silicone breast implant ; Indicated for for... Related causes were inconclusive began losing my hair words ( mixing up words ) short. To my breast implants and had no idea they both mentor memory gel implants recall ruptured combine MemoryShape and MemoryGel Study... Every recommendation mentor memory gel implants recall has now been cancelled to return to the severe pain year feeling!, chronic fatigue, loss of concentration, memory loss, along with fog. Sent me to go to ( b ) ( 6 ) and its too. Disease which always affects my nipple and toes when cold remove the left was adhered to my silicone. Doing research on my hands explant surgeon or explant surgery date as of yet severe lower abdominal pain sent... Natural feel patients desire with increased form stability to shape the breast fd- '' [. Increased form stability to shape the breast tissue itself looked normal started experiencing severe abdominal... In them left fallopian tube and both ovaries due to the job that i.... With brain fog, confusion and cognitive dysfunction is so obvious something i ever had before for years had test... Rare blood cancer company product was approved but was supposed to complete a 10 year Study that has made. To remove implants the following month social, happy, hard-working person of brain to for.

Laws Of Electromagnetism, Pentair Clean And Clear Plus 320, Lenox Hotel Haunted, Army Signal Corps Battalions, Articles M