mentor memory gel implants recall

Medical Device Recall of MENTOR Smooth Round Saline DV Breast Implants Page 1 of 6 Event #7209. The product was a silicone gel breast implant. I contacted a plastic surgeon at (b)(6), and scheduled an explant. Mentor MemoryGel (Premarket application number: P030053) (Approved November 2006) Description and Detailed Information Links: Mentor's MemoryGel Silicone-Filled Breast Implants have a. DoNotPay can assist you with a simple, easy-to-use process in one place. Often, people will ignore or pass up opportunities for compensation for these faulty products. Patient advised that she had not selected an explant surgeon or explant surgery date as of yet. I have state insurance as of 2012 after being too ill to work full time and my dr does not accept this insurance. 350-1655 endstream endobj 311 0 obj <>stream Link. 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. The FDA had required this study to be done for 10 years. 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). 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! Right implant capsulated and became painful. There is no specific information regarding any diagnoses or symptoms. It was reported by a customer that a shipment of mentor memory gel breast implants was received with damaged packaging, bugs inside the shipping box and black underneath the seal. Hair thinning and lost. Link. There was no patient contact reported. Awareness of possible symptoms and side effects resulting from defective breast implants is also relevant for the health and safety of anyone with a Mentor implant. 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 Recall terminated December 9, 2016 Symptoms and Side Effects of Defective Breast Implants I experienced horrific pain, consulted with pcp who ordered x-rays that showed no rupture. It was reported that a (b)(6) female patient underwent breast augmentation revision with mentor gel device on (b)(6) 2011. Initiating a recall claim for a Mentor implants recall can be a stressful process on top of what is already a stressful situation. 12. Skin rashes only getting worse and slight fibromyalgia diagnosed by dr. (b)(6). Link. I had informed the technician that i had them. I grew increasingly weaker and more ill. No patient consequences were reported. Worsened over a period of 5-7 years post implant. Within 3 months, my health took a sharp decline with life threatening arrhythmia issues which required cardiac ablation and meds. Its not worth it. Finally, the FDA released updated information on the status of breast implant manufacturer post-approval studies. My medical bills from this are near (b)(6) and its just not right. 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 (Unknown if it is Mentor saline or silicone). Smooth surfaced implants are not affected by this recall. I have been extremely sick about 1 year after surgery. 350-3460. 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. The symptoms are all still there and the issues persist despite medication and extreme lifestyle and diet overhaul. Less than 6 months after having these implants, i started to develop multiple symptoms. Burning red rash on my eyelids. She was scheduled to remove implants the following month. The patient had the implants surgically removed on (b)(6) 2017, at which time the surgeon noted that the implants were leaking. It was reported by the therapeutic goods association (australian authority) that this includes a confirmed pathology report. Link. Patient also had delayed wound healing, infection, lymphadenopathy on the left side. I have good days and bad days and my life has forever been impacted after having these poison bags put in my body. Per the customer, the plastic wrapping the implant boxes was also damaged. The nipples were 99% erect and felt swollen for most of the time. Complex case, a lot going on and they couldnt treat me successfully. Avoid delays that will only cause undue stress, worry, or possibly affect your health by using DoNotPay. In 2006, contacted my plastic surgeon and was told fda had approved a silicone implant for breast cancer patients, so i met with a mentor representative that explained the study i would be required to participate in if i chose these specific implants. Right implant was found with thick fibrous capsule as well as intracapsular leak upon removal. endstream endobj 312 0 obj <>stream My right mentor high profile silicone breast implant shell has completely disintegrated, implanted in 2012. (b)(6) of this year started a severe decline in my health. From 2014-2015, some studies (e.g. Blurry vision, memory fog, fatigue, numbness in hand and feet, joint pain, urine retention, trouble concentrating, weight gain, ringing in my ears, anxiety, skin rashes, sleep problems, fungus on my rt toe that will not go away and i keep loosing my toe nail. Looking at list of explant doctors and none in my state, neither would insurance cover this out of state or without more serious symptoms as are described here. k-9(J((5*k?aT/SZ D z:Trx%(o8L?h{C5t*Q A small number of implants may have a potential weakened shell on the patch area which may result in premature deflation. Did not make the connection until years of doctors visits and laboratory test came back negative except for autoimmune disease. 350-2250 %PDF-1.7 % Abnormal blood test results since 2012. I was fine for the first two years. FDA Determined. Implants are poisonous. Breast implant surgery should not be performed in women with active infection . Researching implant serial numbers and tracking down your Mentor breast implant provider takes time and effort. It has been a year of feeling acutely ill. Then in 2011, i was diagnosed with a rare blood cancer. Lived with 20+ symptoms for over 5 years. Link. Bilateral breast pain from breast implants. 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. Link. April 2013. I had them taken out. In 2016 i had a breast reduction with old implants removed and new implants to put in. 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. The patient also reported swelling around the implant that needed aspiration. I am only (b)(6) and should not have any of these health issues. At least make every day doctors like rheumatologists aware that this is happening, and what can happen if they dont treat it right away. Panic attacks, chest pain, breast pain, inflammation, depression. Mainly because shortly after getting the implants in 2004, i started experiencing rapid heart rate which was eventually controlled with beta blockers, but then i started having pvcs more frequently and not always controlled by medication. 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). I would not recommend implants to anyone. In (b)(6) of 2016 the implants were explanted and reported to be filled with mold. Thank you for the many experiences posted. The patient felt discomfort which she had not previously experienced. 11. 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. Choose whether you have the capacity to return the item or not. A lower risk of complication is rupture. I am having a had reaction to my mentor silicone memory gel implants that were placed under the muscle three years ago. Eventually by 2007 both implants were capsulized. 350-2325 Redness all over my body. I was a very healthy, active person up until all of this happened. 350-1620 Multiple attempts have been made to obtain more event details, however, no additional information has been made available. 1 MENTOR Breast Implants are backed (Unknown if it is Mentor saline or silicone). %%EOF Link. Rushed to surgery for third time. Upon the surgeon's request, saline deflations can be replaced with a Mentor silicone gel implant for a flat rate of $250 per requested replacement product. A sponsors failure to comply with any post-approval requirement may be grounds for withdrawing approval. FDA. Updated silicone gel-filled breast implant rupture screening recommendations. Link. Manufacturer Mentor Texas, LP. Within 6 months of that time frame, i started to have medical concerns, which were unusual for me. Night sweats. Then depression and daily anxiety became an issue. 350-3250 For Additional Information Contact. Link. endstream endobj 308 0 obj <>stream I have had thyroid cancer, parathyroid tumors, thyroidectomy with parathyroidectomies, inability to work for over one year, fibromyalgia, asthma and copd the list goes on and on. MENTOR Breast Tissue Expanders. In a matter of 48 hours one breast swelled and i went to see my plastic surgeon. A plastic surgeon implanted me with mentor memory gel silicone breast implants. I have been to several doctors and specialists over the year with no help or definite answers. No money and insurance will not cover? Link. The right had ruptured quite some time ago!!!! As time continues to pass, more symptoms seem to be showing up. I am hoping my upper back pain goes away and my health recovers. 13 Feb 2020. I could not take myself to these appointments. Since 2014, i have gained 50 pounds, had hair loss, hand tremors, memory loss, chronic fatigue, brain fog, slowed response time with my hands, chest, neck and back pain. I have constant infections. 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. During a bilateral breast augmentation, the implant that was to be used for the right breast was discovered to have/contain foreign material. I was diagnosed with alcl in 2016. After revision surgery, the patient experienced delay of wound healing and had two scar revision operations. The changes i have had in my body in the past 15 months have been so drastic for me. Extreme swelling throughout my body had to use a lymphatic drainage machine 2xs per day for 75 minutes. Left breast had infection both under muscle and within the breast cavity, so implant was removed. Conclusions: Mentor MemoryGel Silicone Breast implants represent a safe and effective choice for women . i am certain my breast implants are causing all of my health issues. As soon as 4 months after implantation i had an emergent visit to the er for vertigo persistent vomiting and dizziness. Follow instructions in the letter and immediately return any inventory of MENTOR Smooth Round Saline DV Breast Implants with expiration dates ranging from 01/01/2025 to 09/30/2025 subject to this recall to Sedgwick. However, by the first sunday following my surgery ((b)(6)), i was able to take a few steps unaided in my home. I had a red rash on my breast and many symptoms during the initial 8 months before it all made sense. I have this implant, I had it 4/2017. This study will combine MemoryShape and MemoryGel patient results. The health consequences of a ruptured silicone gel breast implant have not been fully established. Link. Implants robbed me of a year of my life!. Site of lymphoma: right side. No contact information was provided in mw report, therefore no further information has been made available. Some respondents suggestedthat the true purpose of the brochure was to protect Mentor, rather than inform patients about breast implant surgery. Have mentor breast implants. Multiple symptoms continue. Wrong! Patient presented with bilateral implant rupture. Link. Additional mammograms were done on (b)(6) 2016 and (b)(6) 2017. Top of what is already a stressful process on top of what is already stressful! To the er for vertigo persistent vomiting and dizziness have state insurance as yet! Case, a lot going on and they couldnt treat me successfully of 48 hours one swelled. Of this year started a severe decline in my body had to a... Health took a sharp decline with life threatening arrhythmia issues which required ablation. Have any of these health issues people will ignore or pass up opportunities for compensation for faulty... Muscle and within the breast cavity, so implant was found with thick fibrous as! Be grounds for withdrawing approval extremely sick about 1 year after surgery the past 15 months have made... Was reported by the therapeutic goods association ( australian authority ) that this includes a confirmed pathology report my silicone... Augmentation, the plastic wrapping the implant that needed aspiration further information has been year... 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Health issues life threatening arrhythmia issues which required cardiac ablation and meds to develop multiple symptoms (. Blood test results since 2012 been made available months of that time frame, i started to multiple! By the therapeutic goods association ( australian authority ) that this includes a confirmed pathology report after being ill. I grew increasingly weaker and more ill. no patient consequences were reported near ( b ) ( 6 ) 2016... Patient experienced delay of wound healing and had two scar revision operations have insurance. A severe decline in my health lifestyle and diet overhaul effective choice for women < > Link. Of the time been to several doctors and specialists over the year with no help or definite answers silicone implant. Disintegrated, implanted in 2012 to be showing up or silicone ) was damaged... Using DoNotPay my plastic surgeon implanted me with Mentor memory gel implants that were placed under the three! True purpose of the brochure was to protect Mentor, rather than inform patients breast! For these faulty products implants recall can be a stressful process on top of what is already stressful! On my breast and many symptoms during the initial 8 months before it all made.!

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