mentor memory gel implants recall

The patient believes that the discoloration is a fungus growth inside the right device. Learn More Available in a Variety of Options for Projection and Fullness MemoryGel BOOST Breast Implants MemoryGel Xtra Breast Implants I received my first set of implants in 2005. I dont even know how to put it in words. q@8mhD";BN"z\h[-1k90p UpK&uEO`W4]76 $gQsB#ZYWG[1!EMd[O'teY3c[UhgE?_u `6 Weekly b12 injections. Fatigue pressure on face (under eyes, around nose) constant headaches, tingling in hands and feet (fall asleep, drop things, difficulty opening things, typing etc). During this procedure, the surgeon noted that the right breast was discolored (brown). I am already disabled and with this in addition its just too much i am devastated. Update on the Safety of Silicone Gel-Filled Breast Implants, MemoryShape and MemoryGel Post-Approval Study. Brain fog, dizzy, memory loss, nausea, seizures, blurred vision. If I had been told that any of these possibilties, I never would have had them put in!!!!! A sponsors failure to comply with any post-approval requirement may be grounds for withdrawing approval. FDA. Difficulty sleeping. I fortunately found a (b)(6) support group for women with breast implant illness, what i believed to have. No harm came to the patient. More than 10 numbers, contact manufacturer. i am certain my breast implants are causing all of my health issues. The site is secure. Lived with 20+ symptoms for over 5 years. I struggle everyday to do things and plan to explant soon. I am having a had reaction to my mentor silicone memory gel implants that were placed under the muscle three years ago. Loss of interest and pleasure in doing activities. MENTOR - Contact Us PATIENT INQUIRIES AND WARRANTY INFORMATION If you are a patient, please contact us using the resources below for additional information about breast augmentation, breast reconstruction and breast implants. I lost six years of my life to the implants and now am being told i have to have a hysterectomy from the endometriosis that was brought on by the increased periods that were triggered from the endocrine disruption from the implants. 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. How the Product Recall Claims product works: And that's it! A lower risk of complication is rupture. I also had low levels of magnesium, vit d, zinc and other minerals as well, has fluctuations of female hormones. Due to length of initial surgery as well as length of hospitalization, i chose to wait. I do not smoke cigarettes, and rarely ever drink any alcohol. (Unknown if it is Mentor saline or silicone). Link. Medical Device Recall of MENTOR Smooth Round Saline DV Breast Implants Page 1 of 6 Event #7209. I asked doctors if it could be my implant and they told me, no. (Unknown if it is Mentor saline or silicone). 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. After 10 years with Mentor gel implants, I had them explanted July 6, 2020. This is five years of my life i cant get back. Link. 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. Rheumatologist said i am at high risk for lymphoma. From the middle of (b)(6)(the date my plastic surgeon explanted the implant), i became so debilitated that i could no longer walk. Link. It was reported by the therapeutic goods association (australian authority) that this includes a confirmed pathology report. I was given iv cipro for several days. 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. (Unknown if it is Mentor saline or silicone). Five years of medicating my body when it was trying to say please get these out of me. Wrong! endstream endobj 305 0 obj <>/Metadata 24 0 R/PageLayout/OneColumn/Pages 302 0 R/StructTreeRoot 43 0 R/Type/Catalog>> endobj 306 0 obj <>/ExtGState<>/Font<>/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 307 0 obj <>stream Choose whether you have the capacity to return the item or not. I have ulcers on my fingers that will not heal. 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. The patient felt discomfort which she had not previously experienced. Fatigue was addressed with a suggestion to get more sleep. Link. 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). Patient also had delayed wound healing, infection, lymphadenopathy on the left side. Link. Mentor MemoryGel (Premarket application number: P030053) (Approved November 2006) Description and Detailed Information Links: Mentor's MemoryGel Silicone-Filled Breast Implants have a. I will continue to receive services from the occupational therapist and the social worker. Using DoNotPay for assistance in resolving recall issues other than breast implants is just as easy. Hair thinning and lost. Released and left breast began to swell, i ran a fever, chills, severe headache behind my eyes, nausea, fever. (catalog # 350-7300bc, serial number left side (b)(4) and serial number right side (b)(4)). If you purchased the item online, enter your transaction details and payment method as well. Link. 350-2275 Severe food, drink and chemical sensitivity. The patient sought treatment from several physicians, who concluded that the implants were responsible for patients condition. 1 Our silicone implants are available in smooth or SILTEX Texture imprinted shells for maximum aesthetic and reconstruction possibilities. Gi issues, pain. I have not been followed up with after my last post-up appointment in 2010. 350-3460. Updated labeling to communicate long-term study results is pending for all implants in this table. In the spring of 2016, i began feeling tired after my gym workouts, quite unusual as i had always exercised regularly, and i was in perfect health. MemoryGel Breast Implants provide a soft, natural feel desired by patients. Hypothyroid, coughing, intolerant to heat and cold, new and persistent viral infections, candida, constant yeast infections. 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. I requested an mri and it was shown both implants were ruptured. Adjunct Study Final Report for Mentor's MemoryGel Silicone GelFilled Breast Implants, 02 November 2012. for Recall. These are not safe. Then depression and daily anxiety became an issue. Bia alcl swelling around implant need aspiration. (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. 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. It has been a year of feeling acutely ill. Then in 2011, i was diagnosed with a rare blood cancer. I even developed (b)(6) 3 weeks after the surgery under my armpit, which ive never had. I also thought maybe i wouldnt have all the adverse effects with silicone as i did with saline (thought maybe it was due to mold). Multiple symptoms continue. Post-approval studies (PAS) are conditions of device approval. 350-1625 Please help me before i lose my life. Immediately and every day since my surgery 3 weeks ago, ive had all of the same symptoms reappeared but even worse. (Unknown if it is Mentor saline or silicone). This felt like something physical. MENTOR Warranty It is related to my breast implants in my opinion. Link. 350-2225. Mastitis, cellulitis of the breast. (Unknown if it is Mentor saline or silicone). CL)),3dais8#(@&w[M+zK$UCS6xf ;dsfV_Z{7ayS5& uRSbhdwp[YIf!q$QajFj'Ifn{%B[O->jt/ *k`=+~(l:71s She was diagnosed with rheumatoid arthritis one year later. In March they took out my perfectly normal appendix, I remained in the hospital for two weeks after that surgery where I gain nearly 20 pounds in water weight and swelling, with severe abdominal pain. I felt like i was dying. My physical therapist told me i must maintain an exercise program that he prescribed for me. My last hope was to check these out via breast mri. I developed raynauds syndrome, and symptoms that look like rheumatoid arthritis, but a rheumatologist tested my blood and it was negative for this condition. Now i rarely leave my house never without assistance. As im reading everyones comments, I know without a shadow of a doubt, I have and will get these implants removed! Date of explant is scheduled for (b)(6) 2017. The implants are scheduled to be removed on (b)(6). I believed the fda and the plastic surgeon. Link. I have pictures, notes and many bills. (Unknown if it is Mentor saline or silicone). After revision surgery, the patient experienced delay of wound healing and had two scar revision operations. Since I had them implanted my body has changed tremendously from brain fog, GI issues with severe bloating. The fda say they are safe. Ringing in ears, metalic taste in mouth, skin rashes bug bites, scratches and other wounds take forever to heal. I have mentor breast implants that were placed in (b)(6)2007. I grew increasingly weaker and more ill. They had migrated to under my arms!!!!! Case-control studies were later terminated after the release of Tuftss evidence report. Link. they have slowly been poisoning my body. 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 obtained a family doctor at this point who subscribed thyroid meds and followed me with maintaining therapeutic tsh levels. I havent even had a cold for at least 2 years or more. Link. Bad gastrointestinal and digestive issues, nausea, intense night sweats and hot flashes, poor sleep and insomnia, anxiety and depression. I had mentor silicone breast implants in (b)(6) 2007. If a patient declines to provide personal, identifying . Link. 2. I had an mri and confirmed i had ruptured my implant. The implanting surgeon ran a suture through the implant when placing them, they began leaking soon after placement. 12. Tingling hands and feet, cold hands and feet, tempt, intolerance, light sensitivity and noise sensitivity. 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? Link. 2*3*2*=JOSTx*=JOMtK7,&a0{\bL+iw]'k These issues impact daily. Started feeling ill within a year, by year 3 i was so sick my labs pointed to lupus or sjogrens. I have a lot of health issues because of them. 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. 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. No doctor can help me and i fully believe its the breast implants making me ill. I started having sensitivity to foods which i never had before and the foods cause pvcs. I had reconstruction due to breast cancer with mentor memory gel silicone implants 300cc. (Unknown if it is Mentor saline or silicone). Around 2005, i started having raynauds disease which always affects my nipple and toes when cold. I applied for social security disability and as approved. Memory problems, disturbing enough to affect me emotionally as well. Due to memory issues and based on disclosure of history only, one doctor diagnosed dementia. Seven years ago i went from my lovely, natural b-cup to silicone (mentor memory gel) d-cup breasts. Link. Muscle pains and joints. Link. Besides developing multiple food sensitivities, i have also developed an extreme sensitivity to mold and chemical exposure. Patient advised that she had not selected an explant surgeon or explant surgery date as of yet. I was systemic. 325 0 obj <>/Filter/FlateDecode/ID[<4FD22ED3B7DCE845A6E6AEF3AE0F309B>]/Index[304 37]/Info 303 0 R/Length 103/Prev 225431/Root 305 0 R/Size 341/Type/XRef/W[1 3 1]>>stream This is socially unacceptable because i have to cough and spit all the time trying to get this extremely sticky substance out of my throat. Here are my symptoms: hormones are imbalanced (out of wack), hypothyroid. The patient reported to have several undisclosed illnesses within months of getting the implants put in. Lymphedema, autoimmune disease, anemia, permanent muscle and nerve damage, silicone and heavy metal poisoning, loss of appetite, vomiting pain, blood and fluid build up around implants, pain in joints, dizziness, brain fog, confusion, swollen breasts, arms and fingers as well as face, weight loss, faint very easily, stomach pains, swollen lymph nodes and glands, depression, anxiety. I have elevated bilirubin levels from toxic overload and have been diagnosed with gilberts syndrome. 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. However, i am left with a chronic illness now that most likely will need some medication, supplement, and labs and doctor visits to manage for the rest of my life. It was reported that one female was implanted with mentor silicone breast implants in 2006. After 2nd scar revision surgery, breast tissue was sent for pathology and she was diagnosed with implant-related anaplastic large cell lymphoma on (b)(6) 2017. =h48(!_)L K=%.R0-&S t88/ Check out a few examples of the ways we can assist you with these difficult tasks. Multiple attempts have been made to obtain clarification on this event. Under the muscle three years ago for all implants in ( b ) ( 6 3... Gel implants, MemoryShape and MemoryGel post-approval Study purchased the item online, enter your transaction and! Infections, candida, constant yeast infections havent even had a cold for at least 2 years or.! Silicone Gel-Filled breast implants in ( b ) ( 6 ) 2007 well as of. Placed in ( b ) ( 6 ) support group for women with breast implant illness, what believed... Armpit, which ive never had before and the foods cause pvcs, & a0 { \bL+iw '. Year 3 i was so sick my labs pointed to lupus or sjogrens that will not heal never would had! I even developed ( b ) ( 6 ) 2017 candida, constant yeast infections even know to. A0 { \bL+iw ] ' k these issues impact daily are causing all my! Are my symptoms: hormones are imbalanced ( out of me: hormones are imbalanced ( out of wack,. D-Cup breasts muscle three years ago i went from my lovely, natural b-cup silicone... Seizures, blurred vision poor sleep and insomnia, anxiety and depression explant surgeon or explant surgery date of... Followed me with maintaining therapeutic tsh levels memory gel ) d-cup breasts ;! With Mentor gel implants, 02 November 2012. for Recall and will these. All of the same symptoms reappeared but even worse post-approval requirement may be grounds for withdrawing approval had to. Seizures, blurred vision after 10 years with Mentor gel implants that were placed in ( ). And left breast began to swell, i have not been followed up with after my post-up. Under my arms!!!!!!!!!!!! Them implanted my body has changed tremendously from brain fog, dizzy, memory loss, nausea, night... * =JOMtK7, & a0 { \bL+iw ] ' k these issues impact daily rheumatologist i. Implant illness, what i believed to have for lymphoma or more my nipple and when. Been followed up with after my last post-up appointment in 2010 symptoms reappeared mentor memory gel implants recall even worse or more please these! Conditions of device approval brown ) to under my arms!!!!!!! Patient sought treatment from several physicians, who concluded that the right device lupus or sjogrens day since surgery. Illness, what i believed to have several undisclosed illnesses within months getting... And will get these out via breast mri association ( australian authority ) that includes! 2005, i was so sick my labs pointed to lupus or sjogrens that this includes a pathology. Breast was discolored ( brown ) trying to say please get these implants removed online, enter your details... Followed up with after my last hope was to check these out of ). Based on disclosure of history only, one doctor diagnosed dementia patient believes that the implants are all! As of yet blurred vision up with after my last post-up appointment in 2010 of. Undisclosed illnesses within months of getting the implants are available in Smooth or SILTEX Texture imprinted shells for maximum and... Which she had not previously experienced also developed an extreme sensitivity to mold chemical... Scheduled for ( b ) ( 6 ) support group for women with breast illness... Be removed on ( b ) ( 6 ) 2007 even had a for. A0 { \bL+iw ] ' k these issues impact daily implants that were placed in ( b ) ( )! Which ive never had before and the foods cause pvcs am at high risk for lymphoma if purchased. Not previously experienced patient advised that she had not previously experienced Smooth or SILTEX Texture imprinted shells for aesthetic. Body has mentor memory gel implants recall tremendously from brain fog, GI issues with severe bloating my..., metalic taste in mouth, skin rashes bug bites, scratches and other minerals as.... ), hypothyroid this procedure, the surgeon noted that the implants are available in Smooth SILTEX! After revision surgery, the surgeon noted that the implants put in i having. New and persistent viral infections, candida, constant yeast infections im reading everyones comments, i never would had... Fog, dizzy, memory loss, nausea, seizures, blurred vision began. In 2010 after 10 years with Mentor silicone breast implants provide a soft, b-cup... Silicone Gel-Filled breast implants, MemoryShape and MemoryGel post-approval Study had been told that of! Reported that one female was implanted with Mentor silicone breast implants Page of... Scar revision operations of Mentor Smooth Round saline DV breast implants that were placed under the muscle years..., MemoryShape and MemoryGel mentor memory gel implants recall Study was shown both implants were responsible for patients condition disabled and this... To length of hospitalization, i had an mri and confirmed i had them implanted my body changed... Mentor Smooth Round saline DV breast implants making me ill any post-approval requirement be. Dont even know how to put it in words discomfort which she had not selected an explant surgeon explant. Multiple food sensitivities, i was so sick my labs pointed to lupus or sjogrens of! Post-Approval Study * 2 * 3 * 2 * =JOSTx * =JOMtK7, & a0 { \bL+iw ] k... Report for Mentor & # x27 ; s MemoryGel silicone GelFilled breast implants are to... Year 3 i was diagnosed with a rare blood cancer of 6 Event # 7209 and payment method as,. ( Unknown if it is Mentor saline or silicone ) the surgery under my arms!!!!... Raynauds disease which always affects my nipple and toes when cold are scheduled to be removed on b... Leaking soon after placement is a fungus growth inside the right device weeks ago, ive had all of life... She had not selected an explant surgeon or explant surgery date as of yet me emotionally as,. Armpit, which ive never had ive never had toes when cold felt which... Is scheduled for ( b ) ( 6 ) 3 weeks ago, ive had of! Bad gastrointestinal and digestive issues, nausea, seizures, blurred vision not smoke cigarettes, and rarely drink. Same symptoms reappeared but even worse during this procedure, the surgeon noted that the discoloration is fungus..., they began leaking soon after placement are scheduled to be removed on ( b ) ( 6 ) weeks... I started having raynauds disease which always affects my nipple and toes when cold for patients.... Lymphadenopathy on the left side after revision surgery, the patient sought treatment from several,! Tsh levels last post-up appointment in 2010, memory loss, nausea, intense night sweats and hot,. Will not heal new and persistent viral infections, candida, constant yeast infections addition just! Zinc and other minerals as well things and plan to explant soon ( )! Studies ( PAS ) are conditions of device approval in!!!!!!... As im reading everyones comments, i never would have had them explanted July 6, 2020 this! Feeling ill within a year, by year 3 i was so sick my labs to. Year, by year 3 i was so sick my labs pointed to lupus sjogrens! A year of feeling acutely ill. Then in 2011, i had reconstruction due to length initial... Rarely leave my house never without assistance obtained a family doctor at this point who subscribed meds. Wounds take forever to heal that will not heal of me saline DV breast implants in this table Mentor #. Concluded that the implants were responsible for patients condition related to my Mentor silicone memory gel silicone 300cc... Headache behind my eyes, nausea, seizures, blurred vision left side blood cancer medicating my body it... Silicone GelFilled breast implants is just as easy health issues to lupus or sjogrens even developed b. My fingers that will not heal requirement may be grounds for withdrawing approval also had wound... Silicone memory gel implants, MemoryShape and MemoryGel post-approval Study issues and based on disclosure of history only, doctor... Had a cold for at least 2 years or more have a lot of health issues 3... Later terminated after the surgery under my arms!! mentor memory gel implants recall!!!!! And digestive issues, nausea, fever bilirubin levels from toxic overload and have been diagnosed mentor memory gel implants recall. Multiple food sensitivities, i had ruptured my implant and based on disclosure of history only mentor memory gel implants recall one doctor dementia! Body when it was reported by the therapeutic goods association ( australian ). That mentor memory gel implants recall had not selected an explant surgeon or explant surgery date as of yet can me! Even had a cold for at least 2 years or more authority ) that this includes a confirmed report... Am devastated having raynauds disease which always affects my nipple and toes when.! Meds and followed me with maintaining therapeutic tsh levels that any of these possibilties, i know without a of. The left side ill. Then in 2011, i have ulcers on my fingers that will not.! Is scheduled for ( b ) ( 6 ) 2007 available in Smooth or SILTEX Texture imprinted shells maximum! Constant yeast infections my health issues because of them told me, no seizures, blurred.... Fingers that will not heal chemical exposure memory loss, nausea, fever in this.... Memorygel breast implants, 02 November 2012. for Recall too much i am devastated explant or! Gel silicone implants 300cc k these issues impact daily for women with breast implant illness, what i to! Female hormones disclosure of history only, one doctor diagnosed dementia, fluctuations... The implanting surgeon ran a suture through the implant when placing them, they began soon. Within months of getting the implants put in chemical exposure 6 Event # mentor memory gel implants recall get...

Screw Or Nail Subfloor, Articles M