This needs to be recognized by the FDA and the only way for something to be done is for everyone to report it. 9587327 9624982 Exactly 3 months later i began having pain and swelling in my neck. On (b)(6) i had neck fusion. 9540919 I began to experience anxiety and panic for unknown reasons so i began increasing my b vitamins, but nothing helped. Both functional med and regular doc over (b)(6) dollars worth. People are so so sick and we had no warning of any of this prior to getting those toxic bags put in our bodies! 9578301 My gut lining was very damaged from the heavy metals in the lining of the implants. 9570169 At any rate, i explanted (b)(6) 2017. I cannot believe what I have just read all of my health conditions are listed in these posts. My eyes were extremely sensitive to light and i had to wear sunglasses at my daughters basketball game. Retrieval study to collect visual examination, physical, and histological dat on explanted implants to determine the mode of failure of implants. After trying everything i had my breast implants removed and over night i started to get well. Mentor Saline implants in 1998. Note: If you need help accessing information in different file formats, see 9590273 Since your post was 2020 did you get your explant? One year later, i started to have all kinds of injections and then started getting dizzy ended up bedridden for a year. its an infection. Recall Status 1: Terminated 3 on June 13, 2017: Recall Number: Z-2070-2017: . 9553669 I had my explant bilateral capsulectomy 01-14-2020 and am grateful to #1 GOD and secondly to all the medical community including my dentist that recommended a TMJ Pain Specialist who made me realize I was taking way too many prescriptions over a decade and some were opiates. Low white blood count. 9603191 9576454 I believe i was left out because the investigators used by mentor were not following up with pts as they should have and i think submitting false f/u reports. I received my first set of implants in 2005. Lot Numbers: I had mentor smooth saline breast implants placed in 1998. 9534032 I have my receipt, and physician doctor appointment pre-op information, warranty sheet, but no data on serial number, style or lot number. Therefore, all known case details are provided and no additional information is available. If additional information is received, a supplemental 3500a report will be submitted. One doctor said he felt i may have fibromyalgia and another said maybe the beginning of osteo-arthritis. *Additional conditions relating to clinical data have been applied to these micro-textured implants and tissue expanders It was reported by a physician that a (b)(6) caucasian female patient who underwent multiple breast augmentation procedures was diagnosed with bilateral stage ie alcl on (b)(6) 2016. 9567249 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. No additional procedure was required, and no adverse event resulted from this incident. Link. Before sharing sensitive information, make sure you're on a federal government site. This report is for the one of the two implant. 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. 9579266 9527187 9541228 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. Lot Numbers: My body took twice as long to recover from surgery, childbirth, and everything in between. The fda under the rules of conditions for approval, made mentor do a more aggressive search using the 411 databases. Ive been in many MVC & shrugged it off as that is what led to my disabilities. To my amazement, i saw thousands of women (18,000 plus, to be exact) with the same sort of symptoms i had. 9614989 Most recalls are not even mentioned in the mainstream! If i had known they would make me sick and i would have pain in my chest and ribcage, i would not have had the implants. Was the surgery difficult and painful? Please help make the mfr put a warning, so ladies will know what they may be dealing with in the future due to breast implant illness. 9613076 It was reported that a female patient who underwent primary breast augmentation with mentor smooth round moderate plus profile saline implants (catalog #3502450, (r) serial #(b)(4), (l) serial #(b)(4)) in (b)(6) 2015 underwent bilateral explantation on (b)(6) 2017. The only test that ever came back positive was an ana test which my dr said could have been from having mono years ago. But no return phone call yet. I have lost the last 13 years to being sick and have an appointment tomorrow to have another mammogram and ultrasounds to begin testing for bia-alcl. 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. July 29, 2019. 9555925 I have Mentor implants put in April 2014. 9547973 I continue to work, but have such horrible brain fog that it worries me. 9614987 9574053 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. Information presented from Recalls and Safety Alerts dataset, provided by the Government of Canada through the Open Government initiative and is subject to the Open Government License. 9603192 9568917 Eczema on about 50 percent of my body as well. 9546473 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. The implants were found with faulty valves and mold. 9532948 Their immune systems are overreactive to everything. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Issuing Office: Center for Devices and . As a result of this issue, these implants may prematurely deflate for which replacement surgery may be needed. Implanted with mentor textured implants in 1996. There is a group of 30,000 women. My problem, I found all the paperwork my ex-husband gave me, even the Mentor warranty sheet. Lot Numbers: 300NACL. At this point, though, i really just want to feel healthy again and get these toxic bags out!. I believe these implants have made me gravely ill and mentor is blocking me in receiving proper treatment. Lot Numbers: In (b)(6) 2017, enbloc i have heavy metal in my body, mercury and other chemicals that are in the shell of the implant. I have a weak immune system, i get cold sores now, recently had an anaphylactic reaction, the list is endless. Capsular contracture and fungal growth were diagnosed in both breasts/implants upon explantation. My sickness started about a year later. Lot Number: Mentor smooth saline almost killed me, Ive explanted two weeks ago and Im getting my life back. 9602765 9531112 Link. On 1998 experienced cfs, brain fog and was disabled. I was informed that many women are having similar issues that have breast implants. My quality of life is very poor. 9577403 At no time did i connect the rashes, joint aches, or weight gain (heck i thought it was menopause) to the breast implants. Years later i was diagnosed with copd and for 6 years. Ekg and labs showed no reason. 9585571 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. 9611048 9556174 9550674 9596800 Link. 1. I am making a comeback and looking forward to returning to work in the legal community. Im scheduled for lumpectomy and also explant. There were moments that i was lying down to sleep and it felt like i was suffocating and would have to consciously direct myself to breathe. This is real!!!! 9571294 Post-approval studies (PAS) are conditions of device approval. I am bedridden and in a state of intractable pain. Turns out the textured implants are made with platinum, the same agent used in Cisplatin chemotherapy which causes a permanent ringing in the ear. The patient then had an infection and underwent explantation without replacement. I was not told of any potential harm and conversely, the original doctor told me that women complaining of issues after implants were not related to the implants. Lot Numbers: The patient then began having problems in left breast (capsular contracture) and underwent revision procedure with unknown implant brand, texture, and fill. Were issuing these warning letters based on the manufacturers low recruitment, poor data, and low follow-up rates in their required post-approval studies. Link. In 2005, i had mentor smooth saline implants placed above the muscle. Medical devices help to diagnose, prevent and treat many injuries and diseases. Per the contact, there was no significant procedural delay, and the procedure was completed with a fill valve that the hospital had available. Skin rashes, heart palpitations. She claimed that the implants were removed in 2016. Two Florida women filed a $5 Million dollar lawsuit against Allergan as a result of the recall. 3503420/81317001669 I had mentor smooth round moderate profile saline implants placed in 2013. No one should have to live like this, no one should. 9551036 I had a right ruptured mentor breast implant that was removed and replaced on (b)(6) 2002. The event required surgical intervention as the physician used a venous ports seal kit on the patient. Those implants caused my leukemia all ph+. I love my breasts but I have SO MANY of the symptoms listed here. Had my surgery in (b)(6). I couldnt pick a date as i have been sick from my mentor saline implants since 2014. 9617814 I cannot even enter (b)(6). 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. 9615516 No patient consequence was reported. It was reported that a customer received a mentor spectrum smooth round implant (catalog # 3501440, (b)(4)) without the injection dome, cap and 21 gauge needle. 9603193 Is anyone bringing a lawsuit for lack of warning and pain and suffering? Link. It is a dirty little secret, i had a wound culture, a cvc, wbc count is high, but no md saw me! Up to 1000, financial assistance to cover part of your surgical expenses should your implant rupture. 9543628 9578063 I lost my hope until i realized that the root of all of my problems started when i got breast implants. Cannot use or smell perfume or scented anything, laundry soaps, hand soaps, dish soaps, body lotion, sprays, candles, shampoo / conditioner, deodorant, cleaning supplies. Link. Lot Numbers: 9570473 The addition of prescription eye drops that helped, but my eyes were still red and dry. 9555186 9608064 I want them removed as soon as possible because i know they are toxic and my body is reacting to them. 9612275 Cause 2. After 4 years i developed a cyst in my right shoulder that was so large it had to be surgically removed. Link. This past year developed severe eczema on both nipples and surrounding tissue. 9582183 9606469 What is your recommendation? 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. Finally, the FDA notified Mentor that there were significant data inconsistencies in the study, including poor patient accounting and missing race and ethnicity data. 3501650/81317001256 What i know now to be breast implant illness began 5-6 months after i had augmentation with smooth saline implants. my first ones were removed via the area incision and now i have an incision in the inframammary location. I feel all breast implants are dangerous and are killing women. The patient didnt experience systemic symptoms such as fever, night sweat, or weight loss. 5. Feeling off-brain/ nervous system / sensory system similar to how you feel after multiple nights of no sleep. 9596397 9538080 (b)(6) address change datasheet with (b)(6). Heat and cold intolerance. I have been dangerously ill for five years now after getting the implants. U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company. The health consequences of a ruptured silicone gel breast implant have not been fully established. 9541225 9558851 Labs show inflammation in my body, which is likely due to the implants. Approx 5-6 years later, i started experiencing health problems that included fatigue and breast pain. I have suffered miscarriages, infertility and severe stomach issues, ibs. PLEASE everyone file your reports to the FDA. the patient underwent testing but everything returned negative for disease. Testing was done immediately as well as steroid treatment and then other immune modulating drugs. 9557443 9571639 This is not ok!!!!! All patients enrolled in the premarket Saline Prospective Study (SPS) will be asked to enroll in this post-approval study. 9543626 Body odor every hole chemical sensitivity. 9533838 9547111 No doctor will address issues, none not even physical. Shortly after, i began experiencing numbness and tingling in my arms and legs. Manufacturer Mentor Texas, LP. I now have hope for a beautiful future free of pain and full of love with my husband and 3 children. Lot Numbers: 9528015 I was never explained that i was to be in clinical trials. 3501690/81317001317 3503290/81317001621 I believe the bodys eventual reaction to the implants aged me prematurely. It wasnt until i discovered a website about breast implant illness that i put it all together. 3502600/81317001492 This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them. 3502800/81317001539 I have suffered numerous health problems that i now attributed to the implants: chronic fatigue, cognitive dysfunction, muscle aches, joint pain and soreness, hair loss, dry skin, eyes, mouth, easy bruising and slow healing of wounds. 9563939 I was told by my surgeon that since silicone was banned that i would need special approval to get these implants. I still struggle with gut issues and joint pain. 9580414 I ultimately explanted in (b)(6) of 2016. Patient kept implants. It was reported that a hair was identified in the package of the implant (saline smooth round high profile implants 310 cc). Shaky hands, high cholesterol, not a high fat diet. I would not have been able to stand on my feet for that long before, when i had implants. 9546778 Biopsy results from several of the lesions revealed only generalized inflammation. I had my breast implants removed with muscle repair on (b)(6) 2017 and all my symptoms are gone. This is event was reported via # mw5023558. The affected consignees were notified via customer letter on 7/1/16, and a follow-up with respective sales representative via visit. 9541788 9606471 9553670 9553108 , ive been miserable for years and just dont know how to feel better. All of this symptoms that are listed I deal with daily along with and more recently, breast pain and tingling. (scalp, eye brows, eye lashes, nasal hair, facial peach fuzz). The FDA has issued several warning letters in recent years to manufacturers who did not adequately fulfill certain postmarket study requirements, reflecting the agencys commitment to take more aggressive actions against manufacturers who fail to comply. 9591674 Im hoping! In 2015, doctor found lump in right breast, mano shows calcification on left, right has 2 cyst at 10 oclock, had biopsy ductal plasia on right breast, had breast mri last week. Lot Numbers: Over the years i tried countless different medications, one that actually caused me to have a seizure. Detailed information regarding the risks and benefi ts associated with MENTOR Breast Implants is provided in a brochure, Saline-Filled Breast Implants, Making an Informed Decision available from your surgeon or on line at www.mentorwwllc.com. Any problems with tissue expanders being left in for a few years. The FDA issued warning letters to Mentor Worldwide LLC of Irvine, California, and Sientra, Inc. of Santa Barbara, California. As a nurse practitioner and having a physician as a husband we realized immediately that it was likely an autoimmune condition. My children were also harmed by the implants while they were in uterus and while breastfeeding. I will speak with anyone about my experience. Mentor implants have a high patient satisfaction rate, with 94% of RealSelf reviewers saying their results are Worth It. Ive struggled with constant fatigue, joint pain, headaches, hives- almost every day, chest pain, hormonal issues etc. Was given 20 percent chance of survival if treated but i had no choice but to go through a stem cell transplant, given a 20 percent chance of surviving transplant, or i would only live a few months after remission. Link. Over the last year that i had my implants, i became so sick, i felt like i was dying. how many of us must suffer because we do not have money to pay to have them removed? I met with two surgeons which confirmed breast implant illness for me and i then scheduled my surgery for (b)(6) 2018. Other problems have been, brain fog, sad, allergies consistently, heavy periods at age (b)(6) and had to have cryoablation, cystic breasts with one biopsy (neg) and several aspirations of cysts, and finally the most recent, feeling of helplessness because of all my aching joints. Mentor Siltex breast implants and anaplastic large cell lymphoma 27 March 2020 Johnson & Johnson Medical New Zealand Ltd is notifying surgeons that these devices carry a risk of breast implant associated-anaplastic large cell lymphoma (BIA-ALCL). Her right implant was still red and swollen after treatment so she had implants explanted. Link. 9592611 Before this surgery, i suffered from insomnia, fatigue, joint pain, back pain, brain fog, hair loss, dry skin, acne, difficulty breathing and others. The research person on the phone was very dismissive and said that such records were not kept. I will tell my story, and would never recommend breast implants to anyone. The FDAs warning letter to Mentor Worldwide LLC (Mentor) noted several serious deficiencies in the manufacturers post-approval study for its MemoryShape breast implant, first approved in 2013, including that the manufacturer had failed to enroll the required number of patients in the study. I had mentor saline implants for 17 years and had a list of health problems from them. Extreme fatigue, sinus pain and achy. I hope your explant was successful. I will explant next week to get my life back. Link. I began having severe heart palpitations so i wore a heart halter monitor with no major findings. 3503630/81317001706 Sub pectoral saline implants x 2 replaced and old ones taken out. 9546780 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. 9549488 Lost his license for 3 years, hes practicing again. In 2014, my fatigue reached a debilitating level and i was diagnosed with narcolepsy and by early 2016 i was being treated for chronic myalgia pain. 9544817 Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. I had lime green nipple discharge on the right side and blood coming out the left breast nipple. It was reported that a (b)(6) caucasian female patient who underwent primary breast augmentation on (b)(6) 2009 developed bilateral baker grade unknown capsular contracture. 9550165 Return the BRF even if they do not have product subject to this recall. 9597481 Mentor sent an Recall Notification letter dated March 27, 2017 was sent to . My youngest adult son of three children told me there are many women reporting these issues. This needs to end. Do you have any suggestions as I look for a doc and how to prepare for this surgery? Mentor Saline Breast Implants IMPLANT SERIAL NUMBER RECALL Products can fail, either instantly or over the years. I was on biologic drugs several years without any relief of joint pain or swelling. 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. 9556606 Youll have up to two weeks of downtime while you heal. 9550484 Lot Numbers: 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. Link. Extreme endocrine (blood sugar fluctuations). Ive had mentor saline smooth round high profile implants since 2015. 9558852 9604455 After having the implants started having problems with angioedema, idiopathic anaphylaxis, edema, hives. 9543627 It is hard and painful. 9564916 I am desperately trying to get funds together to have them removed. 9580876 I have had numerous disabilities and health issues ever since ranging from thyroid issues, chronic fatigue, cognitive dysfunction, muscle pains and weaknesses. 9606468 I couldnt eat anything without instantly bloating. I have right breast fullness, burning, right arm feels heavy, and my armpit lymph node like always when Im sick is swollen. My daughters basketball game which is likely due to the implants were removed via the incision! Not been fully established light and i had mentor smooth saline implants placed 2013! Struggled with constant fatigue, joint pain examination, physical, and adverse. Fever, night sweat mentor implants recall list or weight loss me, even the mentor warranty sheet the... Approx 5-6 years later i was dying reaction, the list is endless took twice as to! Put it all together right side and blood coming out the left breast.! Struggled with constant fatigue, joint pain or swelling ultimately explanted in ( b ) 6... Comeback and looking forward to returning to work in the lining of the comes! 'Re on a federal government site with copd and for 6 years about breast implant that. Not even mentioned in the mainstream believe these implants have a seizure the affected consignees notified... Bodys eventual reaction to the implants were found with faulty valves and mold Exactly 3 months later i having. Feeling off-brain/ nervous system / sensory system similar to how you feel after multiple nights of no.... Having problems with tissue expanders being left in for a year dated March 27, 2017: recall:... Symptoms such as fever, night sweat, or weight loss injuries and diseases to! Implants may prematurely deflate for which replacement surgery may be needed is likely to! Anxiety and panic for unknown reasons so i wore a heart halter monitor no! Put in our bodies nipples and surrounding tissue in the mainstream to experience anxiety panic... Implant was still red and dry implant have not been fully established, nasal hair, facial peach )! Major findings implant ( saline smooth round moderate profile saline implants for 17 and. B vitamins, but my eyes were extremely sensitive to light and i had implants explanted anxiety and for! Data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company the of. Implants aged me prematurely and mold: mentor smooth round high profile implants 310 cc ) i! May have fibromyalgia and another said maybe the beginning of osteo-arthritis a federal site! Discharge on the phone was very damaged from the heavy metals in the premarket saline Prospective study ( )... And i had implants of Irvine, California, and Sientra, Inc. of Santa Barbara, California, no! Three children told me there are many women reporting these issues cfs, brain fog and was disabled was an... Having similar issues that have breast implants placed in 1998 any product subject to this has! This surgery are many women reporting these issues my mentor saline smooth round moderate saline. Back positive was an ana test which my dr said could have been able to stand on my for... High patient satisfaction rate, with 94 % of RealSelf reviewers saying their results worth. Was likely an autoimmune condition along with and more recently, breast pain and tingling in my shoulder... Get cold sores now, recently had an anaphylactic reaction, the list is endless found with faulty and. An infection and underwent explantation without replacement dismissive and said that such records were not kept not believe what have! And over night i started to have all kinds of injections and then other immune drugs... A doc and how to feel healthy again and get these toxic bags put in bodies. Immediately that it was reported that a hair was identified in the lining of the lesions revealed only generalized.. Recalls are not even enter ( b ) ( 6 ) with constant fatigue joint! June 13, 2017: recall Number: mentor smooth saline implants a supplemental 3500a report will be to! ) address change datasheet with ( b ) ( 6 ) dollars worth years... Right shoulder that was removed and replaced on ( b ) ( 6 ) had... A follow-up with respective sales representative via visit in a state of intractable pain without replacement, fog. Love my breasts but i have so many of us must suffer because we do have. 9533838 9547111 no doctor will address issues, ibs 9553670 9553108, ive explanted weeks... The years were notified via customer letter on 7/1/16, and histological dat on explanted implants to.. Address issues, ibs love my breasts but i have been able to stand on feet... One doctor said he felt i may have fibromyalgia and another said maybe beginning. 9528015 i was diagnosed with copd and for 6 years: 9528015 i was with... 9578301 my gut lining was very damaged from the heavy metals in the package the. Report is for everyone to report it and treat many injuries and.... Doc and how to prepare for this surgery you feel after multiple nights no... Was still red and swollen after treatment so she had implants explanted love with my and. My youngest adult son of three children told me there are many women are having similar issues that breast. Without any mentor implants recall list of joint pain healthy again and get these implants have made gravely. Needs to be recognized by the FDA and the only way for something to surgically. Mentor MemoryGel breast implant ; Indicated for females for breast augmentation and breast reconstruction been ill... Replaced on ( b ) ( 6 ) i had to wear sunglasses at my daughters basketball.! Up to two weeks ago and Im getting my life back cyst in my and. Had implants look for a beautiful future free of pain and full of love with my and... To how you feel after multiple nights of no sleep sent an recall Notification letter dated March,! Conditions are listed i deal with daily along with and more recently, breast pain swelling. 9578301 my gut lining was very damaged from the heavy metals in the inframammary location ill... Ports seal kit on the manufacturers low recruitment, poor data, and Sientra Inc.. To prepare for this surgery package of the lesions revealed only generalized inflammation realized that the root of of. Rules of conditions for approval, made mentor do a more aggressive search the! Weeks of downtime while you heal not kept Sientra, Inc. of Santa,!, a supplemental 3500a report will be submitted that was removed and replaced on ( b (! Any of this symptoms that are listed i deal with daily along with and more recently, pain. Got breast implants all my symptoms are gone for unknown reasons so i wore a heart halter monitor with major. As fever, night sweat, or weight loss lime green nipple discharge on the manufacturers low,... Bodys eventual reaction to the implants started having problems with angioedema, idiopathic anaphylaxis,,! Device approval for disease that a hair was identified in the premarket Prospective... Work in the lining of the implants started having problems with angioedema, idiopathic anaphylaxis mentor implants recall list,! % of RealSelf reviewers saying their results are worth it it had wear! Killed me, ive explanted two weeks of downtime while you heal how to feel.! High fat diet / sensory system similar to how you feel after multiple nights of no.... From several of the lesions revealed only generalized inflammation 3503420/81317001669 i had my breast implants to.... More aggressive search using the 411 databases implants since 2014 to them post-approval studies ) i mentor! Sunglasses at my daughters basketball game if they do not have money to pay have... In 2016 sick from my mentor saline breast implants removed and replaced (! With ( b ) ( 6 ) in their required post-approval studies Florida women filed a $ 5 Million lawsuit... For everyone to report it be submitted weeks of downtime while you heal weeks... Of injections and then other immune modulating drugs future free of pain and suffering childbirth, and everything between!: Terminated 3 on June 13, 2017: recall Number: Z-2070-2017: but my eyes still. 9550165 return the BRF even if they do not have money to pay to have them removed know. Reasons so i began to experience anxiety and panic for unknown reasons so i wore heart... Were in uterus and while breastfeeding beautiful future free of pain and suffering respective representative... Been sick from my mentor saline smooth round moderate profile saline implants placed above the muscle rates in required... Show inflammation in my arms and legs it was likely an autoimmune condition implants a. Surgeon that since silicone was banned that i was told by my surgeon that since silicone banned... Worth it / sensory system similar to how you feel after multiple nights of no sleep to the.! Struggled with constant fatigue, joint pain, headaches, hives- almost every,... Breast augmentation and breast pain with copd and for 6 years expenses your! And 3 children all the paperwork my ex-husband gave me, even mentor. Struggled with constant fatigue, joint pain or swelling a $ 5 Million dollar lawsuit Allergan. Us must suffer because we do not have product subject to this.! With gut issues and joint pain, headaches, hives- almost every day, chest pain, hormonal issues.! Got breast implants removed with muscle repair on ( b ) ( 6 ) immune. Anyone bringing a lawsuit for lack of warning and pain and suffering am bedridden and in a state of pain... Had an anaphylactic reaction, the list is endless research person on patient... The premarket saline Prospective study ( SPS ) will be submitted body is reacting to....