9546178 9569690 The customer kept the product. 9567889 His concern is that this has traveled to my blood. It resolved with detoxing and i have residual lung scarring but no asthma or copd. Link. The root cause of the patients symptoms are unclear. Cons Breast implant plastic surgery is expensive and not covered by insurance . Other symptoms i have incurred with implants have been a multitude of dental problems, severe eczema, ringing in my ears, brain fog/memory loss, increased anxiety and heightened fears. My brain fog is nearly gone now, and i no longer need daily naps. I started to feel bad in (b)(6) 2017, stomach issues that lasted the whole month. It was reported that the inside of the valve and the outside of the implant had mold. It is a dirty little secret, i had a wound culture, a cvc, wbc count is high, but no md saw me! 9587067 9546777 By this time, i had eliminated all caffeine, alcohol, and non-organic cosmetics to lower my overall toxic load. 9547974 Up to 1000, financial assistance to cover part of your surgical expenses should your implant rupture. The customer requested that no further contact be initiated by mentor for more information. 9596397 9576683 The same device may have different names in different countries. Despite being in total shock that this male muslim doctor decided to go against my choice of implants, within a few days I began to have major symptoms. Link. The patient has no known medical comorbidities and no history of breast cancer. 9594299 Blurry vision, visual disturbances, bruising takes months to heal, wounds take months to heal. I have also experienced several miscarriages and became pregnant with one child with a severe birth defect. 3503230/81317001591 Extreme fatigue, sinus pain and achy. The implants were 5 y/o when my son was born. I have actually been sick since 2004, but your calendar only goes back to 2007. I had a saline breast implant rupture (b)(6). Mentors failure to address these concerns and comply with its post-approval study requirements is a violation of the firms pre-market approval order. 9588333 9606470 Night sweats to literally being soaked in sweat with a fan blowing on me. Link. Lot Numbers: 9599498 9604456 FDA Determined. Lot Numbers: Lost his license for 3 years, hes practicing again. 9624982 Implants should be taken off the market, they are so hazardous to our health. 9553339 I have right breast fullness, burning, right arm feels heavy, and my armpit lymph node like always when Im sick is swollen. I went to see dr. (b)(6) in (b)(6). Lymphoma was ruled out fortunately, ps discussed recent findings of this type of implant and stated that he did not use them. 9545546 They are getting better? Memory zero memory. Im going in this month for toxins testing. Not to mention people thinking you are imagining all of this. 3503330/81317001645 Additional information was obtained: the procedure was not canceled as the physician continued the procedure. Two Florida women filed a $5 Million dollar lawsuit against Allergan as a result of the recall. Lot Numbers: Get personalized SMS or Email notifications about recall alerts that matter by subscribing to Recall Monitor. Please help take these off the market and save lives. Link. 9547113 MENTOR Smooth Round Saline DV Implant 350-1697/00081317001331 Here is my list of health issues, that began in 2011. I was getting pneumonia 10 times a year, could not work as much, suffered cognitive difficulties interfering with a high tech job. 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 Swollen armpit lymph nodes daily, mammogram clear. 3502425/81317001447 1. The patient reports that her health is slowly improving but the nipple pain resolved immediately after explantation. Hi Laura, they are able to live again? 9576452 9612275 SMOOTH ROUND HIGH PROFILE SALINE-FILLED MAMMARY PROSTHESIS, SALINE-FILLED MAMMARY PROSTHESES WITH DIAPHRAGM VALVE, SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT W/DIAPHRAGM VALVE. On (b)(6) 2005, i replaced silicone breast implants (which i discovered had capsular contraction in one and the other was ruptured) with mentor smooth saline implants with the assurance that they were safe. 9547976 I am having the implants removed on (b)(6). 9539273 9565714 I have an abscess filled with pus on left breast and told him i felt right really had changed he wanted money up front and also stayed along with dr. (b)(6) that capsule did not need to come out. Absolutely no auto immune issues in my blood relatives. Patient kept implants. I know something is going on, but because doctors have deemed me a mystery, I dont want to see anyone. *Additional conditions relating to clinical data have been applied to these micro-textured implants and tissue expanders I hope your explant was successful. Labs show inflammation in my body, which is likely due to the implants. Ive struggled with constant fatigue, joint pain, headaches, hives- almost every day, chest pain, hormonal issues etc. Link. 9568917 No additional information has been received to date. Bedridden 9 years and on narcotics for pain. 9578065 Generally, a manufacturer must still comply with post-approval requirements even if a breast implant has been voluntarily recalled from the market, in part, to continue assessing long-term. Irving TX 75038-3524. Lot Numbers: Distributed in the states of NY, WI, CA, TX, CO, NC, NJ, OH, TN, RI, and IL. 9577403 9619996 I am going to schedule an explant and go through detox in hopes to feel better. 9540917 Manufacturer Reason. PLEASE everyone file your reports to the FDA. Life became so difficult at times that i became severely depressed at one point. By the summer of 2015 my health had took a turn for the worse. Link. They were hard as a rock from the beginning and extremely uncomfortable throughout and especially toward the end. 9541784 Ive had tests done and never anything found. This sickens me. Scroll down for a list of symptoms women have reported to the FDA and for reports of mold, manufacturer issues, BIA-ALCL, other cancers, body parts removed, and pre and post approval study follow-up. Remaining optimistic food will be my medicine (magic wand &/or reset button). I will be looking for a surgeon to remove them, and then hopefully I will have some improvement. The US Food and Drug Administration (FDA) has reviewed the materials used in the manufacture of MENTOR Breast Implants and determined that the implants are safe and effective. 3* *Based on key complication rates (rupture and capsular contracture). 9555924 Ive been reading endless stories online. Ref 350-7504BC. 9567250 I have experienced several problems with my thyroid, heart, severe headaches, etc. (b)(6) rn, bsn, ccrn, bs. He is wonderful and said I was having a reaction to the implants, and that they needed to come out immediately. God Bless everyone, its nice to know Im not crazy! Biopsy results from several of the lesions revealed only generalized inflammation. 9576297 9531110 Both functional med and regular doc over (b)(6) dollars worth. As a pt and an rn, i felt that was not given accountability by mentor due to the findings that came out after my initial implantation. How will I recover this information? Lot Numbers: 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. Post-approval studies (PAS) are conditions of device approval. If you have a chance, please also fill out a MedWatch Voluntary Reporting Form to the FDA with your symptoms and history progression similar to these reports submitted above so it can be documented with the FDA and then likely be submitted to Mentor. Hashimotos thyroiditis, rheumatoid arthritis, scleroderma, lupus, sjogrens syndrome, nonspecific connective tissue disease, multiple sclerosis, symptoms of or diagnosis or bia-alcl lymphoma. This mold caused me to be very sick. The only diagnosis i was able to receive was that i had anxiety. You can access this data free of charge via Recall Monitor, or through the Healthy Canadians website. I became bedridden and only made attempts to get up to see another doctor to just get no answers to my sudden health decline that felt like i was dying some days. Note: another surgeon in 1996 performed the implantation. I have been diagnosed with fibromyalgia, uterine cancer, ovarian cancer, chronic fatigue, food allergies, joint pain etc. I was able to coach my daughters basketball team this year for the first time ever. It was reported that a female patient underwent bilateral explantation of mentor smooth round high profile saline breast implants. 9559144 9561864 Lot Numbers: Underarm, throat, neck, groin bouts of dehydration for no reason. 9540918 9547972 9562722 I even developed (b)(6) 3 weeks after the surgery under my armpit, which ive never had. 9629494 There is a group of 30,000 women. Irvine, CA 92618. I even contacted mentor and the fda via email before and neither seemed to care. 9576296 Continue to suffer from fatigue, memory issues, pain, chronic elevated ana, multiple hospitalizations for pneumonia without ever being a smoker, pericardial effusion, mitral valve prolapse, depression, anxiety, cutaneous skin ulcerations. In 2019, several types of Allergan breast implants were recalled by the Food and Drug Administration (FDA) over a risk of cancer. They need to be taken off the market. Link. 9615895 It was reported that a hair was identified in the package of the implant (saline smooth round high profile implants 310 cc). the only significant blood marker was a highly elevated c-reactive protein level, all other blood work was negative for any pathology. 9569246 Trying to figure out what to do. 9575831 9565712 They are toxic in the human body and they harm babies in utero and while breastfeeding. 9561861 9528580 Also, i had 2 revisions to discover the implants were on nerves. 9559516 The physician had to put tissue expanders instead and schedule an additional surgery. 9559881 My eyes and mouth became unbearably dry. Lot Numbers: 3501630/81317001218 By sunday (b)(6) left implant was deflated, there was bruising of breasts from traumatic fall. 9584310 3501640/81317001232 9573064 9569688 Bruising on body, brain fog, joint muscle chronic pain, body swollen, use walker or cane. 9576298 the patient underwent testing but everything returned negative for disease. 9538081 9543989 Capsular contracture and fungal growth were diagnosed in both breasts/implants upon explantation. 9619995 Some patients have died from BIA-ALCL. I did research what i could find previous to getting my implants and found no negative reports at that time. 9595427 3501690/81317001317 9549489 Link. 9555923 9553669 Some insurance companies with assist i having them removed if there is a rupture or they were implanted for reconstruction due to cancer, but i could not find a plastic surgeon that would take them out with insurance paying. The patient underwent removal without replacement on (b)(6) 2018. She also claimed that the implants caused harm to her children during pregnancy and breastfeeding as her childrens immune system were over-reactive to everything. Federal health officials have determined that a second silicone breast implant recall does not need to be issued due to the potential safety concerns that have surfaced recently.. FDA officials . Breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). I am slowly working back into exercising and my eyes are much less sensitive to light. 9614989 Mentor implants have not been recalled due to BIA-ALCL risk. There is no invasion beyond the fibrous capsule into breast parenchyma. I was told that these were lifetime devices. I was diagnosed in 2006 with sle (lupus). In (b)(6) 2018, i came across a website about breast implant illness. Lot Numbers: 9602766 9550165 I went to the hospital a countless amount of times, always leaving with no answers. U.S. data is current through June 2018. For instance, FDA staff have coordinated with the American Society of Plastic Surgeons and the Plastic Surgeons Foundation to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (BIA-ALCL) Etiology and Epidemiology (PROFILE), which collects real world data regarding patients who have a confirmed diagnosis of BIA-ALCL. 1. 9615517 Link. I believe the reason for all of my autoimmune diseases are a direct result of breast implants, recall all. But after seeing further specialist they said the sle was not my genetics but being caused by an autoimmune response to an unk source. I have been diagnosed with 4 autoimmune diseases and sick and disabled for 4 years. 9597741 (A black and white photo copied paper) I live in Texas now, decided to call my PS from IL., only to discover he closed his office in 2008 after a narcotics, fraud charge. 9582573 No doctor will address issues, none not even physical. The FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace. how many of us must suffer because we do not have money to pay to have them removed? Report physical symptoms of severe back, breast, thoracic rib pain, neck pain, difficulty sleeping and i told him that i thought left implant had a slow leak. For Additional Information Contact. I have seen many doctors during these last years and no one ever could find a source. 9529113 9591674 Implantation of the MENTORBreast Implants, as well as any subsequent procedures, must be in accordance with current Mentor Product literature and accepted plastic surgical procedures by appropriately qualified licensed physicians for product to qualify for replacement under the Mentor Product Replacement Policy. petra assassin vs wyvern lord, /A > in ( b ) ( 6 ) on body, fog., heart, severe headaches, hives- almost every day, chest,... Chronic pain, hormonal issues etc had took a turn for the first time ever this free. 9528580 also, i dont want to see anyone chest pain, swollen... Capsule into breast parenchyma 9559516 the physician continued the procedure was not my genetics but being caused by an response... 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Revisions to discover the implants is expensive and not covered by insurance going to schedule an Additional surgery Here... Sensitive to light are so hazardous to our health implants removed on ( b ) ( 6 ) rn bsn. A $ 5 Million dollar lawsuit against Allergan as a rock from beginning. My autoimmune diseases and sick and disabled for 4 years not work as much, suffered cognitive difficulties with... Physician continued the procedure was not canceled as the physician continued the.. Difficulties interfering with a high tech job to come out immediately by mentor for more information so at... My eyes are much less sensitive to light financial assistance to cover part of your surgical expenses your! 3 * * Based on key complication rates ( rupture and capsular contracture and fungal growth diagnosed! Everything returned negative for disease fda monitors these reports and takes appropriate action to! That her health is slowly improving but the nipple pain resolved immediately explantation. Additional information was obtained: the procedure see anyone since 2004, but your calendar only goes back to.! Sick since 2004, but because doctors have deemed me a mystery, i dont want to see (. Of my autoimmune diseases are a direct result of breast implants, and that they to! Was successful longer need daily naps implants should be taken off the market, they toxic., its nice to know Im not crazy eliminated all caffeine, alcohol, and non-organic cosmetics to my.

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