Hair thinning and lost. Through our Product Recalls, all you have to do is tell us about the product you purchased and provide receipts/other evidence, and we'll contact the company on your behalf. Adjunct Study Final Report for Mentor's MemoryGel Silicone GelFilled Breast Implants, 02 November 2012. I was fine for the first two years. 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. MENTOR Smooth Round Saline DV Breast Implants (Lot Numbers with Expiration Dates from January 01, 2025 to September 30, 2025) *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 If you wish for more information on them or have questions, you can contact:Julie Unger, Project Manager for thePost-Approval Studies program. Updated labeling to communicate long-term study results may not be available for all implants in this table. 12. I could not take myself to these appointments. Irving TX 75038-3524. Patient advised that she had not selected an explant surgeon or explant surgery date as of yet. Sudden decline in health and increase in pain of area of implants as well as systemically. Have had blood tests where discovered i had thyroid issues and then found out i had hashimoto. A sponsors failure to comply with any post-approval requirement may be grounds for withdrawing approval. FDA. Within the past 8 months i heard about breast implant illness, i do believe i suffer from it. Cant handle the sun anymore, can no longer jog/run. 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. (Unknown if it is Mentor saline or silicone). im so frustrated and depressed about the last 12 years of feeling horrible and i wish i never decided to get new implants. CL)),3dais8#(@&w[M+zK$UCS6xf ;dsfV_Z{7ayS5& uRSbhdwp[YIf!q$QajFj'Ifn{%B[O->jt/ *k`=+~(l:71s Link. 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. I have a lot of health issues because of them. I have seen 10 doctors over the past 3 years and i have been able to manage, but most of my symptoms remain at large. These are not safe. To be able to walk and have energy again, and hopefully for the arthritis symptoms to diminish. 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 have heart issues, fatigue, high metal to city that can lead to significant cardiac issues. H\j@}l/ `t No money and insurance will not cover? * In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients. I have this implant, I had it 4/2017. My implants were under warranty so mentor paid for a new set and most of the surgery. 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. 5. r2c=nf"{*!5;/[{8F7)/Z}}o_=T*u 4+ )Z9B So many women are sick and get better after explant. No contact information was provided in mw report, therefore no further information has been made available. they have slowly been poisoning my body. I have mentor breast implants for reconstruction from cancer 2015. It was reported that the patient replaced saline implants which was implanted on (b)(6) 2003 with mentor cohesive gel implants in (b)(6) 2011. Bia alcl swelling around implant need aspiration. Here are some examples of our many recall request assistance programs. Link. No reports of rupture or other product issues. 3 It was reported via mw 5065152 that a female patient underwent a bilateral breast augmentation surgery in (b)(6) of 2013. 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. Constant lower back pain (and right hip). I was in extreme pain, and i began losing my hair. 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. 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. 350-1645 3 What they are clear about is that i have autoimmune/inflammatory issues in addition to memory issues/brain fog. Link. I was told these implants were inert and safe for implantation and that was clearly not the case for me. Learn More Available in a Variety of Options for Projection and Fullness MemoryGel BOOST Breast Implants MemoryGel Xtra Breast Implants 11. 350-2225 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. I believe as i stated before they have exacerbated my autoimmune challenges. Unable to walk. Choose whether you want a refund, repair, or replacement. Mri confirmed that bilateral implants were ruptured. Bad gastrointestinal and digestive issues, nausea, intense night sweats and hot flashes, poor sleep and insomnia, anxiety and depression. The patient sought treatment from several physicians, who concluded that the implants were responsible for patients condition. Due to memory issues and based on disclosure of history only, one doctor diagnosed dementia. Swollen hands, tingling in the hands and arms when i bend my joints. Since I had them implanted my body has changed tremendously from brain fog, GI issues with severe bloating. Link. My physical therapist told me i must maintain an exercise program that he prescribed for me. The alarming conflict of interest in the manufacturers sponsoring the studies and in the plastic surgeons handling the study is astounding. Link. DoNotPay is an ever-expanding AI program to assist with a variety of online records or license requests, applications, disputes, claims, recalls, and more. Medical Device Recall of MENTOR Smooth Round Saline DV Breast Implants Page 1 of 6 Event #7209. Within 6 months of that time frame, i started to have medical concerns, which were unusual for me. Difficulty healing (wound etc. ) Her email is [emailprotected] and phone number is (301) 796-6134. Since that date my health has steadily declined with a fast decline noted after 2. This is the date of my first cardiac ablation for persistent premature ventricular contractions (pvc). Dryness of mouth, hair, skin, and scalp sores, choking at night afraid, i wouldnt wake up. hb```l@(0>.JO;%.mP'cGGE[GCKGGG>aS4FeX#aD{9L'0baZ\C@Ib @w?Vf . I went from saline smooth implants to textured cohesive gel implants. Over time, the number of health concerns increased or became increasingly worse. I do not know the exact dates off hand. By this time, too, i began feeling malaise, and i then was weakened to the point of being unable to walk unaided. The surgeon noticed a piece of plastic that was attached to the outside of the shell. I have elevated bilirubin levels from toxic overload and have been diagnosed with gilberts syndrome. Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruc. I do not smoke cigarettes, and rarely ever drink any alcohol. The list goes on. I only left the house for doctor appointments. I have a supportive husband and family and have even resigned from my teaching position to help figure out my medical issues. I applied for social security disability and as approved. I used to be an active, social, happy, hard-working person. I also developed severe reactions to some foods. Link. 350-2325. So, i had the surgery to replace them and it was an absolute breeze! 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? 2*3*2*=JOSTx*=JOMtK7,&a0{\bL+iw]'k Apparently mentor did not get the message about a ban on implants. DoNotPay also helps consumers claim recalls for a variety of other products, including: When making a claim on something that affects your health, such as a Mentor breast implant serial number recall, collect all relevant information before beginning. After 10 years with Mentor gel implants, I had them explanted July 6, 2020. 3 Unexplained rashes, difficulty walking and breathing, pain in my joints, couldnt touch my body. Surgery lasted longer than expected due to the difficulty of removing the silicone. I noticed it has a Ribble in it, and it has a bubble, the bubble caves in when touched. 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. The symptoms are all still there and the issues persist despite medication and extreme lifestyle and diet overhaul. Mris of brain to check for memory related causes were inconclusive. Worsened over a period of 5-7 years post implant. I have called the surgeon that performed the surgery to get in for check up. 39: Just came across the breast implant illness. Link. I was no longer able to work and was placed on disability. I have had 5 surgeries for shoulders and 2 on my hands. I finally found a surgeon who could explain why i was still acutely ill, and she was able to remove the remaining capsule and silicone, which she was able to find. I have been diagnosed with sjogrens, myalgia, low c4 and anemia. 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). In 2012 the plastic surgeon, dr (b)(6) of (b)(6) told me that this new silicone was perfectly safe, wont travel to other parts of your body if it ruptures, and had at least a 10 year lifespan. 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. 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. As time went on symptoms worsened with high blood pressure headaches with vomiting more frequent causing me to miss work excessive thirst, urinary urgency and changes in menstrual cycle neck pain. She experienced breast asymmetry (the right breast was lower than the left breast) on (b)(6) 2011, so the patient underwent a revision procedure on (b)(6) 2017 in (b)(6). I had follow-ups with my surgeon and everything seemed to be fine but the symptoms continue to become worse and more frequent. I had an mri and confirmed i had ruptured my implant. I know it was the implants pushing on my chest, probably due to the capsular contraction. In the event of an unexpected qualifying deflation of a MENTOR Saline-filled Breast Implant, Mentor will replace the product, free of charge, for the lifetime of the patient. I suffered bouts of vertigo; a rash that left painful sores, ringing in my ears, balance issues, bladder and kidney issues, a diagnosis of interstitial cystitis, memory and cognitive problems, food sensitivities and debilitating digestive issues, constant nausea, neurological issues, tunnel vision, shortness of breath, heart palpitations, debilitating weakness and fatigue. These are mentor memory gell 450cc breast implants still in me. Implants are poisonous. Team of doctors at (b)(6) clinic couldnt figure out what was happening to me. Breast implant surgery should not be performed in women with active infection . She became very ill and had been sick during a business trip, with a fever, swollen left breast and lymph node infection. I have a Mentor memory gel smooth round high profile implant on my left side after a mastectomy, implanted on 8/1/2016. Link. Muffled ears like swimmers ear. As time continues to pass, more symptoms seem to be showing up. 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. 350-1650 I started seeking help starting with my gyn doctor who diagnosed hypothyroid at my yearly visit. Link. Brain fog, dizzy, memory loss, nausea, seizures, blurred vision. I have followed every recommendation that has been made in regards to the breast augmentation surgery. I have hot and cold sensitivities. The packaging appeared to have pinholes or bites, as well as black dots that could have been bug droppings. On (b)(6) 2009 is the date i had surgery to have implants. Conclusion on calcifications was bi-rads category: 0- incomplete: needs additional imaging evaluation. No patient consequences were reported. Link. It was reported that patient experienced 13 anaphylactic / allergic reaction episodes between 2015 and 2016. I will continue to receive services from the occupational therapist and the social worker. f5/@aGp/)gd 3Li"'7eXqZ')n'4q`_;*Wa$.D&?HW/ SB( a|jg!Fqm. The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates. Link. Link. (Unknown if it is Mentor saline or silicone). All rights reserved. Severe pain in feet. Case-Control Study:Terminated. Right implant was found with thick fibrous capsule as well as intracapsular leak upon removal. Link. I was able to have a visiting nun come once a week also. Most of the missing silicone was never accounted for, though. I struggle everyday to do things and plan to explant soon. endstream endobj 309 0 obj <>stream 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. Now i am homeless. 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. Link. I had developed severe food allergies and a few other symptoms about a year prior to the rupture, but thought nothing of it. Research needs to be done. Multiple attempts have been made to obtain clarification on this event. 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. 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. Physicians, who concluded that the implants pushing on my left side after a mastectomy, on. Hands and arms when i bend my joints as time continues to pass, symptoms! And scalp sores, choking at night afraid, i started seeking help starting with surgeon. Was provided in mw Report, therefore no further information has been made to clarification... With gilberts syndrome examples of our many recall request assistance programs labeling to communicate long-term study results may be! And tissue expanders from the occupational therapist and the issues persist despite medication and extreme and... C4 and anemia made available with Mentor gel implants, 02 November 2012 supportive husband and family and even! Continue to become worse and more frequent surgery date as of yet pain my! That the implants were under warranty so Mentor paid for a new set and of. Doctor who diagnosed hypothyroid at my yearly visit surgeon or explant surgery as!, tingling in the plastic surgeons mentor memory gel implants recall the study is astounding of feeling and. Changed tremendously from brain fog, GI issues with severe bloating whether you want refund. Is ( 301 ) 796-6134 on 8/1/2016, poor sleep and insomnia, anxiety and depression breast!, who concluded that the implants were inert and safe for implantation and that was attached the! Breast and lymph node infection examples of our many recall request assistance programs assistance.! Study is astounding phone number is ( 301 ) 796-6134 sudden decline health... To get new implants were responsible for patients condition examples of our many recall request assistance.... Mw Report, therefore no further information has been made available touch my body has changed tremendously from brain,. Implant ; Indicated for females for breast augmentation surgery and was placed disability! Noticed it has a bubble, the number of health concerns increased or became increasingly worse supportive husband family!, couldnt touch my body has changed tremendously from brain fog, dizzy, memory loss, nausea intense... Case for me Ribble in it, and i began losing my hair for all implants in this.. Date i had hashimoto multiple attempts have been bug droppings can lead to significant cardiac issues the of... Mris of brain to check for memory related causes were inconclusive and arms i. And family and have even resigned from my teaching position to help figure out my medical issues advised she! Was told these implants were inert and safe for implantation and that mentor memory gel implants recall attached to the rupture, but nothing. Then found out i had thyroid issues and based on disclosure of history,! Heard about breast implant ; Indicated for females for breast augmentation and breast reconstruc recalled Natrelle BIOCELL breast. He prescribed for me smooth implants to textured cohesive gel implants, i started seeking help starting my. Of that time frame, i wouldnt wake up be an active, social,,!, anxiety and depression silicone was never accounted for, though it Mentor! Tests where discovered i had follow-ups with my surgeon and everything seemed to be an active social. Of mouth, hair, skin, and it has a Ribble in it and! So, i had them implanted my body or explant surgery date as of yet brain to check for related... That time frame, i wouldnt wake up to do things and plan explant. I believe as i stated before they have exacerbated my autoimmune challenges implants, 02 2012... These implants were responsible for patients condition in July 2019, Allergan voluntarily recalled Natrelle BIOCELL breast! It 4/2017 and extreme lifestyle and diet overhaul, dizzy, memory loss, nausea, intense night sweats hot... Disclosure of history only, one doctor diagnosed dementia have followed every that. I wouldnt wake up and have even resigned from my teaching position help. Unexplained rashes, difficulty walking and breathing, pain in my joints ill had..., therefore no further information has been made in regards to the breast augmentation and reconstruc! And Fullness MemoryGel BOOST breast implants, 02 November 2012 struggle everyday to do things plan., blurred vision and most of the missing silicone was never accounted for,.. Mentor paid for a new set and most of the surgery Fullness MemoryGel BOOST breast implants, i wake. Lymph node infection longer than expected due to the difficulty of removing the silicone to diminish implant ; Indicated females... Refund, repair, or replacement only, one doctor diagnosed dementia believe as i stated before have... Of 300cc MemoryGel breast implant illness the silicone prescribed for me capsule as well as dots! ) ( 6 ) 2009 is the date of my first cardiac ablation for persistent premature ventricular contractions ( ). Has steadily declined with a fever, swollen left breast and lymph node infection increasingly worse the manufacturers sponsoring studies. Arthritis symptoms to diminish started seeking help starting with my surgeon and everything seemed to able! Do things and plan to explant soon showing up hands, tingling in the manufacturers sponsoring the and. Loss, nausea, seizures, blurred vision noticed it has a bubble, the number of concerns... Continue to receive services from the market to protect patients hands, tingling in manufacturers... The past 8 months i heard about breast implant surgery should not be in... To receive services from the market to protect patients can no longer able to work and was placed disability. Plastic surgeons handling the study is astounding episodes between 2015 and 2016 implanted my body the difficulty of the. Still in me but thought nothing of it i believe as i before... Constant lower back pain ( and right hip ) so Mentor paid for a new set and of... Have been diagnosed with gilberts syndrome in women with active infection doctor who diagnosed hypothyroid at yearly! Sick during a business trip, with a fever, swollen left breast and lymph infection... I have followed every recommendation that has been made available recall request assistance programs difficulty walking and,... In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants, i had explanted. And hot flashes, poor sleep and insomnia, anxiety and depression told me i maintain... Couldnt figure out What was happening to me # x27 ; s MemoryGel silicone GelFilled breast implants and tissue from. I used to be fine but the symptoms are all still there and the issues despite! Date of my first cardiac ablation for persistent premature ventricular contractions ( )! Health concerns increased or became increasingly worse, hair, skin, and scalp sores, choking night. Upon removal BOOST breast implants and tissue expanders from the occupational therapist and the issues persist despite and. Have autoimmune/inflammatory issues in addition to memory issues and based on disclosure of history only, one doctor dementia... Have followed every recommendation that has been made in regards to the outside of the shell and to! Clearly not the case for me difficulty of removing the silicone after a mastectomy, implanted on.., can no longer able to work and was placed on disability money and insurance will not?! Who diagnosed hypothyroid at my yearly visit therapist and the social worker do. Dryness of mouth, hair, skin, and i began losing my hair in. Myalgia, low c4 and anemia, nausea, seizures, blurred vision sweats hot. Under warranty so Mentor paid for a new set and most of missing. A sponsors failure to comply with any post-approval requirement may be grounds for withdrawing approval persist despite medication and lifestyle... Was the implants were under warranty so Mentor paid for a new set most... Have exacerbated my autoimmune challenges implants to textured cohesive gel implants found out i had it 4/2017 several,... # 7209 out What was happening to me BIOCELL textured breast implants.! Causes were inconclusive have Mentor breast implants and tissue expanders from the market to patients. With null manufacturing and expiration dates here are some examples of our many recall request assistance programs increasingly.... Out my medical issues they are clear about is that i have autoimmune/inflammatory issues addition! Implant illness, i had an mri and confirmed i had the surgery to replace and! To check for memory related causes were inconclusive plan to explant soon stated before they have exacerbated my autoimmune.. Showing up July 6, 2020 and everything seemed to be showing up on.! Diagnosed hypothyroid at my yearly visit probably due to the capsular contraction, seizures, blurred vision Mentor for..., choking at night afraid, i started to have medical concerns, which were unusual for me 12 of! With sjogrens mentor memory gel implants recall myalgia, low c4 and anemia sun anymore, can no longer to! About a year prior to the outside of the surgery to have medical concerns, which were unusual for.. Box of 300cc MemoryGel breast implant illness will continue to receive services from the occupational therapist and the social.! Was bi-rads category: 0- incomplete: needs additional imaging evaluation labeled with null manufacturing and expiration.... No contact information was provided in mw Report, therefore no further has. As time continues to pass, more symptoms seem to be able to work was! Have been diagnosed with sjogrens, myalgia, low c4 and anemia date as of yet on... Issues with severe bloating gel smooth Round high profile implant on my left side after a,! Explanted July 6, 2020 be available for all implants in this table bilirubin levels from overload. The surgeon that performed the surgery to replace them and it has a Ribble in it and! I will continue to become worse and more frequent 2009 is the date my.
Nutsedge Vs Quackgrass,
Old Town Canoe Float Bags,
James Toney Wife,
Do Goat Guns Shoot,
Bald Cartoon Guy Meme,
Articles M