3503500/81317001683 800-235-5731. 9620460 Shaky hands, high cholesterol, not a high fat diet. On (b)(6) 2016 i had to undergo a 7 hour surgery to remove the toxic mentor saline implants that have been deteriorating my health for years. I am desperately trying to get funds together to have them removed. I even contacted mentor and the fda via email before and neither seemed to care. His name is Dr. Bradford Roberg in Crystal Lake, IL. In 2002 i began having health problems. No one should have to live like this, no one should. Link. I have actually been sick since 2004, but your calendar only goes back to 2007. 9631722 Link. Fda confirms all are bad, then recall any implants and make mentor, dow corning, allergan, etc pay for full explanation of all implants, including capsule and repair damage done to womens bodies. 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. I am having the implants removed on (b)(6). July 29, 2019. I had very high levels of several heavy metals in my blood. Medical devices help to diagnose, prevent and treat many injuries and diseases. Lot Numbers: Thank you for your time. 9532948 I think 90 percent of the symptoms I have. (b)(6) address change datasheet with (b)(6). During routine set up, the physician found that the package of the implant did not contain the dome pack accessory. Never was i contacted for any f/u. Swollen armpit lymph nodes daily, mammogram clear. Also, i had 2 revisions to discover the implants were on nerves. Same here. 9574052 Mentors failure to address these concerns and comply with its post-approval study requirements is a violation of the firms pre-market approval order. 3502500/81317001478 Lot Numbers: 1. 9540917 Link. 9553340 I have had these implants for 6 years (smooth round high profile gel) I have literally been sick with a lot of these symptoms since a month after having them put in..I recently have been put through test after test and they cant seem to find anything Ive told them its the implants but no luck.Finally a plastic surgeon agreed to remove them on dec.19th .thank you I will continue to follow this page .. Cassandra , have u improved since ur implants was removed? Before sharing sensitive information, make sure you're on a federal government site. 3503250/81317001607 9569247 I noticed you had an implant around the same time as me 09/06/2002 Ref 350-3290 LOT 248483 MENTOR Hi Pro Sm Rd Sal-Mamm Prosth SN#TX-1297216 (Left) and (Right) is SN#TX-1297215. 9566957 9555927 9578063 9558222 9535132 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). 3503420/81317001669 9603190 There was no previous history of autoimmune disease. Got my implants removed after 8 years in 2015 and 75 percent of the symptoms went away. Some symptoms have already gone away and some have gotten better. 9528841 9606469 9595691 Link. Mold was reported in the valve and on the outside of the implant. 9541463 Health care professionals and consumers should report any adverse events related to breast implants to the FDAs MedWatch Adverse Event Reporting program. 9547113 9553111 9571640 Link. I am bedridden at (b)(6). 9546177 9589651 9608405 Saw an ent and was told i needed to get my deviated septum fixed and thats why i was so tired and had sinus pain. My eyes and mouth became unbearably dry. Approximately two weeks after the procedure, the patient began to experience a number of symptoms, including extreme anxiety, numbness, tingling, joint pain, brain fog, memory loss, confusion, vision problems, food allergies, difficulty walking, breathing issues, muscle atrophy and hormonal issues. 9614987 The FDAs actions today are part of the agencys ongoing commitment to its public health mission of ensuring patient access to safe and effective medical devices. My problem, I found all the paperwork my ex-husband gave me, even the Mentor warranty sheet. He was able to locate me by my name and dob, locating my implants and told me to find a surgeon and they would send his replacement implants. The pains chronic and worse now that Ive decided to stop the use of Fentanyl (late Jan. 2018). 9550164 After my breast augmentation, i started to get intense neck and shoulder pain along with numbness in my hands and fingers. I was forced to go to er on (b)(6) 2017, and then to top it off, they are not staffed with an er md? According to the company, "a small number of devices, due to an issue involving specific . I am now in addition to suffering from a myriad of diseases (some not confirmed via scans etc) suffering from extreme stress, case has been escalated with (b)(6) and right implant has deflated on this date of (b)(6) 2017. 9586784 I became very ill, diagnosed with fibromyalgia, capsular contra (grade 3 and 4) many symptoms to include; chronic body pain, breast pain, chronic fatigue, hair loss, muscle, joint weakness and pain, ringing in ears, ibs, insomnia, anxiety, depression, tingling and pins and needles in hands and feet, headaches, weight gain, food intolerances, shoulder, neck, back, arms, hands, leg and foot pain, heart palpitations, shortness of breath, inflammation, diagnosed with fibromyalgia and arthritis, breast tumors and cysts. How many women must get sick? No extended hospitalization was required. 9537339 Link. Tear duct plugs were placed, which helped a bit. Link. I now have heart issues, elevated blood pressure, inflammatory arthritis, lyme disease, morgellons, ulcerative colitis and neuropathy. 9538081 This needs to be recognized by the FDA and the only way for something to be done is for everyone to report it. Lot Numbers: Today, the U.S. Food and Drug Administration issued warning letters to two breast implant manufacturers for failure to comply with their requirements, under their premarket approval orders, to conduct post-approval studies to assess the long-term safety and risks of their silicone gel-filled breast implants. They were hard as a rock from the beginning and extremely uncomfortable throughout and especially toward the end. 9611601 My symptoms: fatigue or chronic fatigue cognitive dysfunction (brain fog, difficulty concentrating, memory loss), muscle pain and weakness, joint pain, hair loss, dry skin and hair. 9625685 I have seen many doctors during these last years and no one ever could find a source. I was healthy prior to 5 years ago, currently show autoimmune symptoms with neg blood work. 3502700/81317001515 9588333 Link. Link. 9538080 Rashes and sensitivities to any lotions, perfumes. In 2008, the patient has a bilateral revision augmentation due to capsular contracture with unknown implant brand, texture, and fill. 9614477 9574861 So I called Mentor, they have his name in their data base, but say he didnt report any implants nor did he place an order for an implant until December of 2001. There is not a recommendation that women who have had these implants placed explant them. 9589650 Skin rashes, heart palpitations. 9559516 9530728 Released from hospital only to go back in 3 days later with worsened symptoms. I have a weak immune system, i get cold sores now, recently had an anaphylactic reaction, the list is endless. I drank so much water, i believe it would throw my electrolytes off and i needed salt tablets to prevent my blood pressure from being erratic. Mentor saline breast implants that i got in 2003. I had a foggy brain and extreme fatigue, headaches, insomnia, swollen lymph nodes, puffy eyes, extreme thirst, difficulty concentrating, remembering things and depression, as well as loss of vision (and brown spots on the iris). I survived by using lists in everyday life. I started having serious difficulty breathing at all times, and especially when laying down at night. Further on March 22, 2021 in Philadelphia, the law firm Berger Montague announced that many claims for injuries arising from the recall of Allergan's Biocell textured implants will now proceed to Discovery, read more here. 9564914 9589074 January 2020 kidney stones removed, blood work pretty good other than low iron still, then in November 2020 high liver enzymes and 2021 diagnosed with autoimmune hepatitis. I had a saline breast implant rupture (b)(6). The manufacturer had poor follow-up rates with patients. 9535386 I had so much tissue and muscle wasting and weight loss. 9541787 My primary care physician cannot come up with any findings related to my overall health except that the fact my body is being compromised by breast implants that were deemed safe. All patients enrolled in the premarket Saline Prospective Study (SPS) will be asked to enroll in this post-approval study. I was given chiropractic and physical therapy treatments that did not help. 9533840 9610037 Currently, the manufacturer reported a follow-up rate of 61 percent, which is below the target follow-up rate. Lot Numbers: 9537340 All of my joints and muscles hurt so bad. Link. I had my breast implants removed with muscle repair on (b)(6) 2017 and all my symptoms are gone. I went to the hospital a countless amount of times, always leaving with no answers. Lot Numbers: I used to work 80 hours a week and raised 4 children alone. Finally, i developed a goiter and a high cortisol level. In 2022, the global breast implant market had a valuation of just over $2 billion, and it is anticipated to grow at a CAGR of 5.0% during the forecast period, reaching almost $2.9 billion. 9611603 How will I recover this information? Capsules were thick, yellowish and my chest full of yellow murk liquid. The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates. 9580873 Lot Numbers: It resolved with detoxing and i have residual lung scarring but no asthma or copd. Mold toxicity was suspected, so the patient underwent bilateral explantation on (b)(6) 2015. It was reported that there were brown flakes on the implant that were noted out of box. 9553109 Muscle pain, back pain, gingivitis even with excellent oral hygiene. 9528580 United States The patient underwent bilateral explantation with total capsulectomies and no replacement implants in (b)(6) 2016. 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