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Mentor Silicone Breast Implant Lawsuit Not Preempted, Cleared To Proceed: Judge

  • Written by: Irvin Jackson
  • 17 Comments

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A U.S. District Judge has cleared the way for a Mentor silicon breast implant lawsuit to proceed, indicating that that the claims over health complications caused by a ruptured implant are not preempted by federal law. 

In a memorandum opinion and order (PDF) on January 11, U.S. District Judge Gary Feinerman denied in part and granted in part a motion to dismiss filed by Mentor World Wide. As a result the lawsuit can move forward, but without some of the original claims.

Catherine Gravitt and her husband, Travis, filed the original complaint (PDF) in the Circuit Court of Cook County, Illinois in June 2017, and the case was later removed to the U.S. District Court for the Northern District of Illinois by Mentor.

According to allegations raised in the product liability lawsuit, Gravitt was implanted with textured Mentor MemoryGel Silicone Breast Implants in 2010. However, she began to suffer muscle soreness, fatigue, abnormal thyroid levels, drowsiness, anxiety, and depression.

As a result of the breast implant complications, Gravitt underwent a number of procedures to alleviate the symptoms, and later gave birth to a son with severe heart defects, and a daughter with severe bladder and kidney defects, as well as additional physical and mental health problems.

It was not until 2016, after a lump developed in her breast, that Gravitt’s doctor discovered that the Mentor breast implant ruptured and had been leaking. The lawsuit blames Gravitt’s health problems and her children’s birth defects on the allegedly toxic materials leaked from the breast implant into her body.

She underwent revision surgery in October 2016, and several lymph nodes were removed as well, due to silicone contamination, the lawsuit indicates.

Mentor tried to have the case dismissed, arguing that the claims were preempted by the fact that the breast implant was approved for use by the FDA. However, Judge Feinerman noted that Gravitt’s original claim noted that Mentor had failed to disclose to the FDA certain details in its original studies regarding health complications suffered by women during clinical trials.

“Plaintiffs may proceed with Catherine’s claim that Mentor violated its state tort law duties by concealing that the risk of gel bleed associated with MemoryGel was higher than the company publicly revealed, and with Travis’s associated consortium claim,” the judge ruled. “Plaintiffs’ other claims are dismissed, though the dismissal is without prejudice.”

Judge Feinerman indicated that the plaintiffs have until February 1 to file an amended complaint, which could reinstate some of the dismissed claims.

The case is one of several lawsuits filed against Mentor over silicone breast implant problems.

Silicone Breast Implant Concerns

Silicone breast implants were introduced in the 1960s, and were removed from the market after safety concerns were raised with the FDA in 1992, amid reports of breast implant ruptures. A moratorium was placed on the silicon implants until findings concerning their long-term safety could be determined.

The implants were reintroduced to the market in 2006, after no definitive links to health side effects or disease were found. The FDA ruled against a second silicone breast implant recall in 2011, and called for improved surveillance, demanding manufacturers perform long term follow-up studies.

Researchers have struggled to determine the health risks linked to silicone breast implants. In November 2015, a study in the Annals of Internal Medicine found an association between silicone breast implants and an increased risk of lung cancer.

However, the same study also linked silicone breast implants to a decreased risk of breast cancer and endometrial cancers.

In 2012, UK health officials said the silicone gel in Poly Implant Porthese (PIP) breast implants was not toxic to women. The report revealed the implants had a tendency to rupture in on-third of women, but the industrial-grade silicone gel was nontoxic.

In 2011, the consumer watchdog group Public Citizen warned that the FDA did not adequately alert women to silicone breast implant risks. The group advised women against getting the silicon implants.

Breast Implants Lymphoma

Last year, the FDA issued warnings about breast implant lymphoma rates, indicating that the agency was aware of at least 359 medical device reports worldwide involving women diagnosed with the rare form of non-Hodgkins lymphoma, including at least nine deaths.

In June, another study published in the medical journal Plastic and Reconstructive Surgery suggested that certain textured breast implants may increase the risk of anaplastic large cell lymphoma anywhere from 10 to 14 times, when compared to smooth breast implants.

In October 2017, a study published in the medical journal JAMA Surgery warned that many breast implant cancer cases worldwide have likely not been reported, and noted that doctors and patients may not be aware of breast anaplastic large-cell lymphoma (ALCL). As more information becomes public about the breast implant cancer cases, experts have warned that the number of cases reported will likely increase significantly.

As regulators and researchers worldwide continue to evaluate the specific cause of the breast implant lymphoma problems, many women are raising serious questions about why certain products appear to be more likely to be associated with the development of cancer, and how manufacturers failed to address potential design defects earlier.

Product liability lawyers in the U.S. are reviewing potential textured breast implant lawsuits for women diagnosed with anaplastic large cell lymphoma (ALCL), which develops in the tissue surrounding the breast.

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17 comments

  1. Carol Reply

    I have been very ill sense my Mentor High Profile Silicon Breast Implants we’re put in 8/10/07
    I have been to so many doctors that could not find what was going on with me, now I know I have become very disable from Breat Implant Illness.

  2. Lisa Reply

    Mentor ALSO did not follow through with the 10yr protocol advised by the FDA per their PMA introduced in 1999 for saline smooth round implants. If you check the FDA data base for PMS…there is none. My saline implants were never approved and informed consent was never given to thousands of women. The FDA has dropped the ball many times over and Mentor are the biggest criminals in the game.

  3. Rachel Reply

    I was implanted with mentor silicone gummy implants December 2016, and explanted July of 2017 incorrectly by a doctor who swore “the capsules will disolve, and the symptoms are all in your head.”

    I am extremely ill which began with implantation, and I have gotten progressively sicker since explant.

    My symptoms include fibromyalgia, chronic fatigue, low blood pressure, high cholesterol, weight gain, brain fog, depression, anxiety, joint pain, muscle weakness, insomnia, food sensitivies, and chronic pain. None of these things were an issue before I was implanted.

    It is unconscionable that doctors continue to implant these devices and then dismiss the symptoms thousands of women are suffering, and dying, from.

  4. deborah Reply

    Hi, my name is Deborah and I got saline breast implants fin Chicago in 2007 the implants are from mentor. My sickness did appear back in 2012 with weight gain and no matter what i did i can not loose weight. I also developed wheat allergies back in 2016. about two weeks ago i had to be rushed into the ER because i was having chest pain and heart pain. the dr were going to do a stress test but could not because my son couldnt spend the night. the reason for the test was because my EKG test for the heart was showing heart failure. I went to my cosmetic dr and told him all my symptoms: blurry vision, migranes, back pain, dizziness, fatigue, brain fog, and painful stomach cramps, i cant sleep and i cant loose weight. I told him and all the drs i dont smoke i dont drink alocohol and i have never done drugs. the only different thing about my body is implants. no body helped me and i knew i had to take these objects out because they were literally killing me slowly. i begged my family for help and they did. I went to Dr. in naperville Illinois to do an explant. i explained to him why i want them out and of course denied the implants were the problem. I also told him I want to keep the implants and he said he will call to find out. After my surgery which was yesterday he did not even show me the implants i was to sleepy to ask any questions they just rushed me out. today when i went to my follow up I asked the dr. for the implants he said he cannot give them to me because they are a “bio-hazards” and he didnt want to show them to me for that reason so he said he is sending them to MENTOR to be tested.
    I feel they are mine and i was robbed off what I payed for. I know the implants had something and the Dr. is concealing the matter. I dont know who to turn for guidance except the Lord that he will guide me to the correct law firm. I was robbed off my health for 11 years i was never warned of any side affects and now that i believe that i had the proof that was also taken away from me. if they are biohazards then obviously he didnt want me to know the truth.

    can you let me know what to do or recommend me to a closer firm.
    Thank you,

    Debbie

  5. Amy Reply

    My implants are from 2003 silicone gel by mentor so called study I never heard from ever!!! Ruined my life endometrial cancer a hysterectomy at 24 then I have anxiety depression I don’t leave the house no career nothing I’ve missed my kids events life events ….I became hooked on pills due to pain my credit destroyed from doctors

  6. Karen Reply

    Hello, in 1994 or 1995, my dr put silicone implants into my body. This past December 2018, overnight I woke up with bad pain in both BREST , worse in left… went on every morning for a week, and slowly always went away, next morning I woke up to absolutely no pain , I was confused as to what that was all about, figured was maybe something like a cold that settled in my breast? I was just glad that pain was gone… got out of bed started brushing my teeth, looked into the mirror and omg, my nightmare was just starting , both breast had swelled to 3 times in size, left more… very long short beware what I had happened to me in hours, strong smell of infection, wondering if I was moist or what under my breast, went to work came home and didn’t have to wonder any more liquid was running down my body the smell escalated to being so sting and foul was enough for me, I grabbed my cell charger, keys and drove to Er , required 2 emergency surgeries in February 2019, I was lucky they say so far, the cultures from surgery revealed the most aggressive and deadly bacteria infection, never seen in United States , both implants spilled silicone into me, my surgeon took photos , FDA HAD SILICONE BANNED, WHAT THE FUCK WAS I DOING WITH THEM IN ME? This is criminal and this MENTER product ( actually bought out by Johnson and Johnson ) isn’t in the human body by sex, blood, etc. it’s inroduced into the human body ( can we say silicone) and stays for many years within it , myself and surgeons feel this is the incubation time and feel some may have died already but no dr knows or heard of it, so written off as unspecified infection, soon same surgeons feel many will be coming out of the woodwork , this infection never merely dies of and stops, it kills!

  7. Kathleen Reply

    Watching the news today about implants that are causing so many women to become sick. When hearing the types of illnesses my jaw dropped. My husband said to me it’s your implants. In 2012 I had mentor high profile gel implants put in. In 2016 at age 35 I had a total hysterectomy because of chronic pain, following the surgery I have had continued health issues. I’m 38 and I have connective tissue disease, rheumatoid arthritis, neuropathy and chronic fatigue. In 2017 my health had become so debilitating i could not perform my job duties and eventually had to quit. I worked in health care for over 17yrs.
    This is crazy that all my symptoms could be caused from my implants.

  8. Cynthia Reply

    I was implanted with Mentor memory gel implants in 8/2011. I really never should have been. Leared by the surgery in the first place as I had been diagnosed with Lupus and was on depression medication .
    My lupus symptoms were very minimal and I never had to take meds so I tjouhht it would all be ok.
    After my surgery I began to have joint pain and swelling, muscle weekness, fatigue, anxiety, hair loss, rashes, scalp issues, difficulty swallowing, dry eyes and mouth wjth ulcers in my mouth and nose. I was given so many steroids and am now pre diabetic. I have permanent joint damage amd I feel like my cognitive abilities have sharply declined.
    I feel like my surgeon was neglegent for placing the implants in the first place and Mentor is criminal for not following FDA research guidlines to insure safety.

  9. Lalitha Reply

    I had mentor silicone breast implants In 01/2007 , with in a few weeks I started having symptoms and signs suggestive of very severe systemic chemical toxicity affecting every organ in my body (lupus like syndrome ) . I had multiple hospital admissions , surgeries & came close to death. Have to completely stopped working last year at the peak of my career, what I went through was hundred percent preventable , it is time we make some changes immediately .

  10. Bonnie Reply

    Just had 30 year-old implants removed on February 21, 2019. Have been sick with every single autoimmune disease possible over the last 30 years and never once did anyone suggest that any of my health problems could be related to my breast implants. Prior to my surgery, during the first part of February, I ended up in the ER due to extreme pain in my right breast and difficulty breathing. In addition to this, my right breast grew to almost twice the size of my left breast in a weeks time. MRI revealed that my right implantand had ruptured and that I had encapsulated contractions (or something like that). in essence scar tissue that was acting like a vise grip in my chest cavity and making it almost impossible to breath. They were certain I was having a heart attack in the ER. When they opened me up, blood poured outbof my chest cavity, as did the silicone that had ruptured in my chest cavity. My surgeon said that both implants had ruptured and had most likely been ruptured for years based on the massive amount of scar tissue that had formed. Prior to my ER visit I had no idea that my implants could rupture or that it was dangerousvto have mammograms every year. My original surgeon never told me any of this could happen to me, just that I would be sore for 2-3 weeks after the surgery. Period! And no-one in 30 years ever told me that all of my health issues could be related to my silicone implants. Since my 1st ER visit, prior to my explant surgery, I have read 100’s of stories, articles, and reports and have been hortified by what I have read. I have experienced every single symptom mentioned!! I don’t understand how not one single doctor in the past 30 years could not have mentioned that all of my health issues might have been related to my silicone implants that were slowly poisoning me and destroying my health as they were slowly killing me!! How is that even possible?! Especially in the last several years as my implants began to get hard and my breast grew a whole cup size from a C to a D. All they told me was that as women got older their breast grew — even though the rest of me never did. I have always been 125-127 for as long as I can remember. Now I am concerned about the blood cancer that 30 year old silicone implants can cause. Any suggestions. I would love to talk with someone who has gone through this and who may have a good attorney. I need help. My name is Bonnie and my phone number is (530) 921-7151. May God help each of us as we try and regain our health. God speed to us all.

  11. Jana Reply

    I have had my silicone implants since 94. I was told they had ruptured about 7 yrs. ago & the silicone is in my lymph nodes under my right arm. I can’t afford to have them removed bc I’m on Medicare. I keep having musle spasms under my right rib cage, I also have a lot of the other symptoms you talk about also. I need help finding a Dr. in Okla. that can do the removal the right way & find an attorney also.

  12. Amy Reply

    I had my breast augmentation in, honestly I don’t know. I know that they’re Mentor; high profile, silicone.
    That is one of my issues, brain fog! Along with circulation, cold tingling hands/feet, insomnia, fatigue, walking, muscle weakness, muscle pain, heart palpitations, breathing difficulties, anxiety and more than ever lately depression..
    I am 33 years old, but every time I go to say my age I literally have to do the math because I can not remember my age. Since getting implants I have seen many many doctors. Besides my PCP, I see 2 Sleep Specialists, 2 Neurologists, a Gastroenterologist, as well as a Physical Therapist and the list goes on.. I have so many autoimmune disease symptoms and would like to explant, but it’s too costly. My body feels overloaded with toxins and stress.. I just pray that one day I will get to be one of those overjoyed women sharing her story about explanting saving her life..

  13. Suzanne Reply

    I’ve had Mentor implants since 1990, so 29 years. I started feeling sick about a month after I got them but never thought it was caused from the implant since my surgeon had said they were 100% safe, he even said they make baby bottle nipples from silicone! He also never told me to have them replaced after 10 years. he said, when you’re 80 years old, your breast will still be perky and all your friends breasts will be hanging down to their knees. Exact words. No mention they had a shelf life and would need to be replaced! about a month after I got my implants, I started feeling so tired I could hardly function, body aches, joint aches, just felt like I was getting the flu but it never went away. I’ve had days of feeling ok…. and days I thought I would like to just die today instead of getting out of bed. I’m motivated and have 5 kids, so staying in bed and dying was never an option. I want to feel good and have a lot of things I want to do but I never know if I make plans, how I’m going to feel the day of those plans. I have read up on all my symptoms and just thought it must be fibromyalgia or something like that. I’ve told my doctors about my symptoms and they seriously look at me like I’m crazy because on the outside I look fine, other than my eyes, They always look red and toxic to me, not the same clarity I used to have. After awhile, you get tired of telling people you don’t feel good and just give up saying anything and try to live the best way you can. Well, about 3 years ago, I had a mammogram that hurt so bad I bout went throght the roof. She bruised me so badly I wanted to punch her. My breast started sagging after that day, never perky since and they started hurting so bad, getting worse all the time. I can’t raise my hands above my head without pain and my left arm pit is totally numb. I can’t swim or workout without pain. If I lay on my back, I can hardly breathe, but do the doctors care when you tell them? NO! when I told my doctor I think my implants are making me sick, she said REALLY???? and just smiled at me like I was stupid! I convinced her to send ne for an ultra sound and the dr said both my implants are ruptured and said I need an MRI to make sure. OMG! so I have this crap leaking into my body all this time. I even breast fed my last child and she has chronic illness, always sick! Probably from my implants leaking. I feel so desperate to get these out but no one else seems to think it’s a reason to panic. I am so regretful of getting these. Biggest regret of my life!

  14. Stephanie Reply

    Wow. I had silicone gel textured implants put in 2008. Mentor. I was a case study patient that had to see another doctor afterwards because mine died. Last year I have symptoms I try to push off on simple illness or just working too much. Fatigue, memory fog, insomnia, joint paint, anxiety and headaches. Then about about month ago night sweats, cold feet and hands, feeling full after I barely eat. Tingling feet. Then as of 2 weeks ago feel breathless. Feel like I can’t breathe. Just chalked it up to maybe a respiratory illness or allergies. But now I need to see a dr. I am in the process of getting insurance shopping around since self employed. This is scary. I thought I was just worrying about nothing. The night sweats made me think of menopause but I have normal monthly periods and no other symptoms of menopause. I’m 42.

  15. Brunilda Reply

    My daughter got breast augmentation done thus May. After the surgery she started to complain about pains and swelling. Her right arm was also kind of numb. After visiting the doctor and finally seeing him. He says she has Capsular Contracture Stage 4 and that she needed a second surgery. The second surgery didn’t get done because the implant was leaking and now my daughter has an infection. She has to wear a pump for 2 weeks and drain the fluid out..Her implants are MENTOR.. Can she get any type of health as a third surgery will be needed

  16. Donna Reply

    Mentor Spectrum Smooth Saline Adjustable Implants
    May 2006 April 2018
    Adenocarcinoma NSCLC, Having double mastectomy October 2nd 2019.
    Host of symptoms remain. This will be my last surgery to find out completely just what I do have. I will be to the chest Flat and I can’t wait to be Free of this “ Barely Living” Nightmare.

  17. Michelle Reply

    I had to have my implants removed in 2005 because the left one had ruptured. I knew something was wrong when I made the appointment at the Dr. when he operated he found that it had ruptured and also disintegrated into my body. I guess its needless to say that I have been sick for years. I was diagnosed with Autoimmune hepatitis in 2014,had two total knee replacements in 2017 that still are not healed which makes it hard to get around. I then had a brain tumor in 2018 and had to go through major brain surgery. I have been going through depression for years,I have gained weight that I cannot lose 100lbs from all the steroids I have had to take. The headaches have left since the brain tumor removed, but I still have cognitive issues because of the tumor. I had bells palsy after the brain tumor for about 3 months. I am on a host of medications and the azathioprine I have to take for the rest of my life for the Autoimmune illness isn’t good for the rest of your body.
    I’m with you Ladies on all the issues concerning this matter, and I am sick of trying to get someone to help me.

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