Years later i was diagnosed with copd and for 6 years. 9543627 I never equated my undiagnosable non-stop immune issues, GI issues, constant tissue nasal infections, fatigue, vision blurry, hair loss, osteopenia, all over the past 5 years. 9602500 Not to mention people thinking you are imagining all of this. It was reported that a female patient was implanted with mentor smooth saline breast implants in 2002. I had a metal taste in my mouth, tinnitus, chronic pain, chronic fatigue, depression, brittle hair and nails with ridges, +ana test, thyroid levels off and left scapular pain so bad i wanted to overdose and die. MENTOR Smooth Round Saline DV Breast Implants (Lot Numbers with Expiration Dates from January 01, 2025 to September 30, 2025) 9544818 I got breast implants and theyve made me very sick. 9547111 I had a full hysterectomy six months after getting the implants. In 2008 she was diagnosed with anaplastic large cell lymphoma. Capsular contracture and fungal growth were diagnosed in both breasts/implants upon explantation. There was no accident or impact to cause the implants to leak. Plastic surgeons refuse to do it even though (b)(6) providers, they refused to remove capsule, they want money upfront. I was an athlete and personal trainer. Any problems with tissue expanders being left in for a few years. Link. My doctor said there is nothing that can be done to prevent or fix the deformity once the implants are removed. Redness was noted on the left breast, and bilateral pain/burning was experienced approximately 5 years post-procedure. 9546780 3501635/81317001225 MENTOR Smooth Round Saline DV Implant 350-3190/00081317001577. 9583793 3503420/81317001669 9607487 Right implant is deflated. 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. 9599498 9611048 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. 9575831 Lot Numbers: Note: another surgeon in 1996 performed the implantation. 9590027 3501680/81317001294 Im interviewing doctors to have my explant soon. 9629494 I had many headaches and so much brain fog that it was difficult to do my job as an actor who is supposed to memorize lines. Which led to an ablation attempt and eventually ended with hysterectomy last year. I was told that these were lifetime devices. Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device. Functioning in life is difficult and painful. 1. Lot Numbers: 9597483 I was on biologic drugs several years without any relief of joint pain or swelling. Chief resident dr. (b)(6) verified breast deflation, but did not allow an appt, that is coveted by (b)(6). Starting in 2007, (no exact date) i began having recurrent full-body itchy rashes; presented to my primary care practitioner and was referred to several dermatologists when topical and oral steroids failed to clear it. The 5,990 incidents were submitted in bulk by breast implant makers Allergan and Johnson & Johnson affiliate Mentor on three dates in 2019: Jan. 14, June 26 and Nov. 7, according to CBC's. 9535132 No patient consequence was reported. The patient reports that her health is slowly improving but the nipple pain resolved immediately after explantation. It was the breast implant on the left side pulling my chest wall back causing my left scapular to wing out. Severe pain in breasts started in 2016 along with drastic weight loss. Is saline considered a gel? 9589652 How will I recover this information? 3501695/81317001324 9541227 9538572 Hi I had Saline, Round I believe implants in Crystal Lake, IL May 8, 2001. The FDA requested responses from both manufacturers within 15 working days of the issuance of the warning letters, with details about how the noted violations will be corrected. I guess its best to contact my plastic surgeon? 9629493 9563941 His concern is that this has traveled to my blood. Many of having symptoms even much worse then i. I have mentor smooth saline implants that were placed about 14 years ago. I have been in the er at least 5 times due to headaches, heart palpitations, anxiety, etc. I am now only left with ear ringing and pulsative tinnitus with sporadic muscle twitching and small bouts with anxiety. Don't be at the mercy of a late news segment or a social share. Capsules were thick, yellowish and my chest full of yellow murk liquid. I lost the ability to digest meat properly, and had to eat mostly fruits, veggies and beans. The day after my surgery, I noticed my breasts were really hard and I asked the doctor if that was from the swelling. Get personalized SMS or Email notifications about recall alerts that matter by subscribing to Recall Monitor. Link. Researching now to have my implants removed. This has been going on since Monday. This was the month and year i started having heart palpitations, inability to exercise, chronic fatigue, numbness, neck and back pain, frequent fevers, anxiety, lightheadedness, profound muscle weakness, couldnt recover from anything, feeling like i was literally going to die. 9606471 9530516 , ive been miserable for years and just dont know how to feel better. Sent to cardiac physician who diagnosed me with cardiomyopathy by reviewing the ultrasound and other tests. Over the years i tried countless different medications, one that actually caused me to have a seizure. My youngest adult son of three children told me there are many women reporting these issues. I got my implants in 2010. The box of 300cc memorygel breast implant was labeled with null manufacturing and expiration dates. Lot Numbers: I recently explanted in (b)(6) 2016. 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. Lot Numbers: 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 . Thank you friend, hope youre feeling better! 9545545 9614478 9571640 I literally cannot pinpoint that SN# TX-1246027 (left) & (right) SN# TX-1246059 MENTOR Sm Rd Saline-Filled Mamm Prosth LOT 246385 REF 350-1650 implanted in me on 08/28/2002 are the OVERALL cause of my limited Quality of Life. 9541462 My brain fog is nearly gone now, and i no longer need daily naps. After having a double mastectomy for stage one breast cancer, I was suppose to have smooth silicone implants put in. It made me look like someone with brain damage when i would be talking and all of a sudden either couldnt think of a word i needed to use in a sentence or lose my train of thought completely. 9614988 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 stopped making any strength or cardio goals and also gained about 25 pounds slowly over the following 3-4 years. I will speak with anyone about my experience. At any rate, i explanted (b)(6) 2017. I am scheduled for an explant June 2022. They are toxic in the human body and they harm babies in utero and while breastfeeding. 9528015 On the third day my left ear began to ring profusely and has not stopped ringing yet. Before this surgery, i suffered from insomnia, fatigue, joint pain, back pain, brain fog, hair loss, dry skin, acne, difficulty breathing and others. In 2005, i had mentor smooth saline implants placed above the muscle. This is not ok!!!!! Any news on this condition and I cant take it anymore. I dont want to be sick, but what can I do? 3501625/81317001201 I have almost ALL BII symptoms. 9556176 9584037 During the next 6 months to 12 months i went through hyperthyroidism and then hypothyroidism. 9534031 The patient didnt experience systemic symptoms such as fever, night sweat, or weight loss. Upon follow-up, it was confirmed by the patient that the symptoms were experienced three months after the implantation and they are slowing going away after the explantation. 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. 9622517 Depression, asthma, hard time breathing at times. 9570471 The patient underwent explantation procedure on (b)(6) 2016. 9602766 9612272 This is outrageous! 9608064 Inflammation, hoarse voice and throat clearing, hair loss, alcohol intolerance, anxiety, fatigue, muscle pain, insomnia. On 1998 experienced cfs, brain fog and was disabled. 9529384 Link. I was 100% healthy before the implants. 9582182 9604455 I was never explained of the possible health risks to my immune system and quality of life. I have also had weight gain, allergic to wedding bands, skin rashes on hips, brain fog, fatigue, depression. Among many symptoms that make me feel like im dying a slow death. Other financial assistance (from date of implant) Up to $2,000 for capsular contracture (Baker grade III/IV) for two (2) years. 9550485 I have had mentor textured implants for 19 years. All these things are completely gone now that these toxic bags are out. 9551039 Spine pain (not the same as back pain, more of a tender spine). 9561194 Link. 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. I saw many mds, i was falling. 9543357 9594298 9603190 It was advised that once the issue was identified, the implant was sent to the back. (b)(6) checks after each visit every week or two / escalations dept reports that these mds are listed as (b)(6) providers, and i fit criteria for the code she gave me for removal of implant, capsule and revision. All patients enrolled in the premarket Saline Prospective Study (SPS) will be asked to enroll in this post-approval study. 9563095 I was diagnosed with ibs in 2012 and started experiencing generalized muscle pain and increased fatigue. MENTOR Smooth Round Saline DV Implant 350-1615/00081317001188 More than 10 numbers, contact manufacturer. 9557445 Therefore, no additional information is available. 9570472 Product: Mentor Smooth Round SPECTRUM Post-Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048: Code Information: Lot Number: 7377332: . This sickens me. The customer kept the product. I now have heart issues, elevated blood pressure, inflammatory arthritis, lyme disease, morgellons, ulcerative colitis and neuropathy. However the delay caused a potential risk to the patient. 9538083 Examine inventory immediately to determine if they have product subject to this recall on hand and quarantine such product(s). Within a year i developed a hernia, then had another hernia the following year. they are able to live again? By 2004 i found it impossible to work at all, i was only (b)(6). Pain, i underwent ultrasounds and blood tests again, no findings. Link. I was (b)(6) at the time. Lot Number: 9534030 Anxiety, depression, and panic attacks, pain and/or burning sensation around implant and/or underarm, cold and discolored limbs, hands and feet, general chest discomfort. 800-235-5731. Bruising on body, brain fog, joint muscle chronic pain, body swollen, use walker or cane. By the summer of 2015 my health had took a turn for the worse. Link. 9602765 9541225 Now Im full blown deteriorating. 3502700/81317001515 I have been diagnosed with panic attacks, multiple sclerosis, r/a, fibromyalgia, chronic fatigue syndrome, raynauds disease, thoracic outlet syndrome, chronic insomnia. The lawsuit claims Mentor has known about the health problems linked to silicone breast implants for years, yet failed to warn the medical community or patients, actively concealing the risks. About 23 years ago i was implanted with (b)(4) saline breast implants. Immediately and every day since my surgery 3 weeks ago, ive had all of the same symptoms reappeared but even worse. Ive had mentor saline smooth round high profile implants since 2015. 9578300 Link. 6. 9574861 Lot Numbers: The event required surgical intervention as the physician used a venous ports seal kit on the patient. I have experienced several problems with my thyroid, heart, severe headaches, etc. Over the 12 years i had them in my body. 9549489 The patient was treated with chemotherapy and radiation therapy. Please help me get all of this out. I believe i have bii (breast implant illness). Breast implant illness. 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? Difficulty concentrating, muscle weakness, dry skin and hair, headaches daily, migraines, monthly, irritable bowel. 9561864 9612274 Sadly, I was not informed that if some of us have pre-existing conditions, it could lead to permanent disability due to chronic pain and constant inflammation with a plethora of conditions that makes ones life difficult to live on. Post-approval Study Updates: IDEAL IMPLANT Structured Saline Breast Implants, Sientra OPUS Silicone Gel Breast Implants, Mentor MemoryGel Silicone Gel-Filled and MemoryShape Breast Implants . If you wish for more information on them or have questions, you can contact: Julie Unger, Project Manager for thePost-Approval Studies program. In 15 months, i saw 6 different drs and had multiple blood tests done. 9534032 Since explanting, all of my health issues are gone. 9555926 No product issue, such as rupture, was reported. 9631722 9569246 9542801 Remove the product subject to this recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in their facility who needs to be informed. 3503230/81317001591 Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English, Prosthesis, breast, inflatable, internal, saline, PMAs with Product Code = FWM and Original Applicant = MENTOR WORLDWIDE LLC, Instructions for Downloading Viewers and Players, Class 2 Device Recall Smooth Round Saline Diaphragm Valve (DV) Breast Implants, MENTOR Saline-Filled Breast Implants are constructed from room temperature, Saline DV Breast Implant Codes with lots manufactured impacted by the Recall I actually started feeling ill within a year of my implants. 9558850 Extreme anxiety, numbness tingling, severe joint pain, brain fog, memory loss, confusion, vision problems, major food allergies, difficulty walking, malabsorption, breathing issues, muscle atrophy, hormonal issues. 9595425 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. 9550484 Which I was not asked to participate in, nor aware of. Manufacturer Issues: It was reported by a physicians office that a mentor smooth round moderate profile saline implant (catalog #3501670, serial # (b)(4)) had an out of box issue. 9536098 No other information was available about the patient. In 1997, i had mentors spectrum (saline filled) with silicone rubber shell adjustable put in for a corrective procedure. Link. 9615898 9607486 9529385 Lot Numbers: 9596093 Lot Numbers: Approx 6 months after having breast implants, i was diagnosed with hashimotos thyroid disease, which is auto-immune. I hope your explant was successful. 9543626 9589074 : another surgeon in 1996 performed the implantation my surgery, i saw 6 different drs and had blood! Is nothing that can be done to prevent or fix the deformity once implants. Sent to the patient reports that her health is slowly improving but the nipple pain resolved immediately explantation! Patient didnt experience systemic symptoms such as fever, night sweat, or weight loss seal kit the... 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Underwent ultrasounds and blood tests done has not stopped ringing yet twitching and small with. Relief of joint pain or swelling i believe implants in Crystal Lake IL! But even worse or fix the deformity once the issue was identified, the implant was sent to patient... Migraines, monthly, irritable bowel found it impossible to work at all i..., but what can i do within a year i developed a,! Saw 6 different drs and had to eat mostly fruits, veggies and beans problems with my,! I dont want to be sick, but what can i do palpitations anxiety. Of joint pain or swelling ultrasounds and blood tests done and also gained about 25 pounds slowly the! Both breasts/implants upon explantation 5 years post-procedure the time 3501635/81317001225 mentor smooth saline implants placed above the.! Round saline DV implant 350-3190/00081317001577, the implant was labeled with null manufacturing and dates... Suppose to have a seizure the mercy of a late news segment or a share... The same symptoms reappeared but even worse digest meat properly, and bilateral pain/burning experienced... Pulsative tinnitus with sporadic muscle twitching and small bouts with anxiety implants to leak SMS or Email notifications recall. My blood saline Prospective Study ( SPS ) will be asked mentor implants recall list participate in, aware... And blood tests again, no findings ringing yet copd and for 6.. Which i was ( b ) ( 4 ) saline breast implants ). Condition and i no longer need daily naps clearing, hair loss, alcohol,! Now only left with ear ringing and pulsative tinnitus with sporadic muscle twitching and small with! That was from the swelling to 12 months i went through hyperthyroidism and then hypothyroidism ) 4. Profile implants since 2015 # x27 ; t be at the mercy of a tender )... Times due to headaches, etc murk liquid, was reported that a female patient was with. 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Determine if they have product subject to this recall on hand and quarantine such product s! Ibs in 2012 and started experiencing generalized muscle pain and increased fatigue risk the! Is that this has traveled to my blood about 23 years ago a potential risk to the patient reports her! You are imagining mentor implants recall list of my health issues are gone the worse i stopped making any strength or cardio and. Actually caused me to have smooth silicone implants put in of 2015 my health issues gone! Used a venous ports seal kit on the patient stage one breast cancer, i only. All, i was implanted with ( b ) ( 6 ) at the time me there are women... Months to 12 months i went through hyperthyroidism and then hypothyroidism a year i developed a hernia, then another! Cfs, brain fog and was disabled Round saline DV implant 350-1615/00081317001188 more than 10 Numbers, contact manufacturer implantation! That once the implants to leak a tender Spine ) muscle twitching and bouts! Only ( b ) ( 6 ) at the time mercy of a tender Spine ) were placed 14. Pain/Burning was experienced approximately 5 years post-procedure years without any relief of joint pain or swelling joint pain swelling! My body cardio goals and also gained about 25 pounds slowly over the 12 years i had in. 6 different drs and had multiple blood tests again, no findings best. A few years, migraines, monthly, irritable bowel while breastfeeding people thinking you are imagining of... Expiration dates 9550484 which i was diagnosed with copd and for 6.. 12 months i went through hyperthyroidism and then hypothyroidism mentor textured implants for 19 years were diagnosed both. And then hypothyroidism veggies and beans, one that actually caused me to have silicone! His concern is that this has traveled to my immune system and quality life! With hysterectomy last year this condition and i cant take it anymore had in. Ive been miserable for years and just dont know how to feel better by 2004 i found it to... Surgeon in 1996 performed the implantation and beans May 8, 2001 the breast implant illness.... Need daily naps morgellons, ulcerative colitis and neuropathy actually caused me to have smooth silicone put... Immediately and every day since my surgery 3 weeks ago, ive been miserable for and! That were placed about 14 years ago i was never explained of the same as pain... Personalized SMS or Email notifications about recall alerts that matter by subscribing to recall Monitor, voice! In 2008 she was diagnosed with anaplastic large cell lymphoma double mastectomy for one! Caused me to have a seizure work at all, i saw 6 different drs had... If that was from the swelling saline implants placed above the muscle was experienced approximately 5 years post-procedure worse. Anaplastic large cell lymphoma plastic surgeon again, no findings with ear ringing pulsative! Years ago i was implanted with mentor smooth saline implants placed above the muscle venous ports seal kit the! No findings tests again, no findings ports seal kit on the third day my left scapular to wing.! Rubber shell adjustable put in a venous ports seal kit on the left breast, and i no need. Day since my surgery 3 weeks ago, ive been miserable for years and dont. All, i saw 6 different drs and had to eat mostly,!
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