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Silicone Breast Implant Lawsuit Filed Over Problems with Allergan Natrelle

  • Written by: Irvin Jackson
  • 27 Comments

An Arizona woman has filed a product liability lawsuit against Allergan, alleging that she suffered a number of complications from the company’s Natrelle silicone breast implants, including neurological problems and vision loss.

The silicone breast implant lawsuit (PDF) was brought last month in the U.S. District Court for the District of Arizona by Nicole Weber, who indicates that after she suffered silicone bleeding into her body from the Natrelle implants.

According to the complaint, Weber received the implants in 2009, following a bilateral mastectomy due to breast cancer. Weber alleges that the Allergan Natrelle silicone breast implants were defectively designed and also claims that she was unwittingly enrolled in a safety study for the implants, without consent.

Weber indicates that her plastic surgeon, Dr. Bryan W. Gawley, directed her toward silicone implants despite her concerns about the safety of the device, telling her that they were proven safe and that the only women who were “kooks” complained about silicone implant problems.

The lawsuit claims Dr. Gawley was actually an investigator with the Breast Implant Follow-Up Studies Program (BIFS) and an agent for Allergan; information he failed to pass on to Weber.

BIFS is a 10 year prospective study ordered by the FDA after the silicone breast implants were allowed back on the market in 2006, following a 14-year ban. The study has the goal of recruiting 50,000 subjects.

Weber claims she was told to fill out BIFS questionnaires, but was never informed that she was part of a safety study on breast implants or that BIFS was related to Allergan.

After receiving the Natrelle silicone implants, Weber indicates that she began to experience complications that included tightness of the breasts, migraines, involuntary jerking and vision loss. Dr. Gawley repeatedly told her that the complications could not be caused by the Natrelle implant until they began to be more pronounced. Other specialists then told her that she had silicone sensitivity, after which Gawley suggested the implants might be bleeding into her body.

Weber had another plastic surgeon remove the implants in 2011, while Dr. Gawley continued to express doubt that they were causing her problems. Although many of the complications were alleviated with the removal of the implants, she continues to experience vision problems and problems with her immune system and extreme sensitivity to medications.

Weber is suing Allergan for product liability and negligence, and is seeking damages for financial loss, medical expenses, permanent injury, mental and physical pain and suffering and other damages.

Silicone Breast Implant Problems

In recent years, the FDA has issued several warnings to consumers regarding silicone breast implant side effects.

Women who are considering receiving silicone gel-filled breast implants have been advised by federal health regulators that they should be aware that the implants are not lifetime devices and that the longer they have them, the more likely they are to suffer complications.

In January 2011, the FDA also warned that both silicone and saline breast implants may be linked to a form of cancer known as anaplastic large cell lymphoma (ALCL). While it can form in the breasts, it is not considered breast cancer. No cases of ALCL were diagnosed among participants in the latest study.

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27 comments

  1. Carl Reply

    What happen did she win her case I hope so my wife is suffering from the same thing except she has mentor

  2. MonicaU Reply

    I am very interested in hearing what the outcome of this lawsuit was. I have been suffering with the same simptoms for about 8 years and doctors cannot figure out what is wrong with me and it is progressivly getting worse.

  3. MaryPat Reply

    I am one of Nicole\’s 4 sisters and I have just returned from Tampa -to help her get thru this complicated detox treatment. She was a successful attorney in Phoenix and has a husband and adopted 12 yr. old son. She lost her job and has not been able to live w/her family since last Christmas. We are hoping to reverse some of the vision loss thru IV therapy but she has been thru hell with this. Finally – many more cases are surfacing and three Dr \’s have agreed to testify against Allergan. Please lookup \”Blinded by my Boobs\” and read my sisters story. The judge in Phoenix is still considering whether the case can go to trial. We are hopeful. If anything- tell everyone you know to look- up Silicon Implant patient stories . The saddest part is that she had just suffered a double mastectomy due to breast cancer and trusted a Dr. that failed her miserably not only in stating the products safety and then ignoring her repeated concerns. By the time the implants were removed her silicone levels were thru the roof and the toxin took over her body. Please take the time to read the stories and warn others.

  4. Amy Reply

    I have allergan Natrelle implants – also part of the study.
    I am having quite a few of odd symptoms. It’s like my body is super inflamed. It was not until after to going to my OBGYN that I learned that potentially all of my symptoms could be from silicone leaking into my system.

  5. carl Reply

    I am so sorry….Who are the 3 dr.\’s willing to testify? I need a lawyer for California, do you know of anyone with experience? My wife is getting her implants out next month…she is very sick as well. Any help will be appreciated.

  6. judy Reply

    I lost some lymphnodes from the damage of silicone implants caused me,now my lymphnodes are hard as rocks and swollen,so this has been ongoing,this is no joke girls…doctor in California did the test and biopsy,found infections in the lymphnodes removed too..

  7. Karen Reply

    What was the outcome of the case? I also had Natrelle implanted in 2009 and within 2 months started experiencing joint pain. 2010 Diagnosed with RA and Osteopenia. Tested positive for silicone poisoning. Had them removed 10/13 so hopefully I will get back to somewhat healthy.

  8. MaryPat Reply

    a follow-up to my Sept. 6th post. The judge through out the case against the product – if the FDA approved them – they must be safe???? She is still seperated from her family in treatment/detox and the lawsuit is now with the plastic surgeon. Our family is working hard to continue to help pay for her treatment – we just want her to be able to come home to Phoenix and return to a “somewhat” normal life w/her husband and adopted son. Please – if anything reach out to family/friends/co-workers/ who may be considering breast augmentation and ask them to research their options (saline/silicone) and make an informed decision.

  9. Nicole Reply

    Just one clarification I did lose my case at the federal district court level but it is on appeal to the ninth circuit so there is still hope.

  10. Becky Reply

    Hello Everyone. I am a claimant in the Dow Corning Class Action. I became a claimant in June of 1994. My mentor Silicone breast implants were in my body from 4/90-10/94. The FDA took them off the market one month after they were put in. My story is long and painful. I wish that I would have sued the DR. and the manufacturer. But I was in a position that I had know choice by the time things were fiqured out. We all know the implants are unsafe…..just make sure they tell you that they are and they have INFORMED CONSENT to experiment on your body. Because you are the research and so am I.

  11. amy Reply

    I had these natrelle implants in my body for less than a year…and had them removed due to similar symptoms. I was told the implants were intact upon removal..however..I am still dealing with heart and possible endocrine issues as well as vision, fatigue, weakness, etc. I never had these issues prior to these being put in. This is my one and only experience with implants. I would never trust anyone telling you how safe these are….they arent!

  12. Laura Reply

    I need some help … please … my dtr had a bilateral mastectomy for HR2 positive breast cancer she had Allergan breast implants in Raleigh NC in Oct 2008 she has been suffering from many neurological problems; skin rashes of unknown etiology; swelling of feet and hands and NOW the breasts are disfigured … the surgeon who did the implants NO LONGER participates w/her Medicare carrier … need help in finding a surgeon who will evaluate and remove these if they are leaking … any suggestions ? your help will be greatly appreciated thanks

  13. Nicole Reply

    If you google breast implant support forum you can find discussions of a dozen or so doctors who are very familiar with these cases and could evaluate your daughter. Just run a search in the forum using the words explant physician

  14. Shannon Reply

    I also have Allergen implants and am having them removed at the end of the month. I had no idea how unsafe these things were prior to getting them. The PS made it sound like they were safe! Well I have had chronic pain and am fed up! I found a support group online (RealSelf) and found out I’m not alone with explanting. I just received the book “The Naked Truth About Breast Implants from Harm to Healing” and wondered if there have been any Allergen Lawsuits which is how I found this. I pray your sister gets better and she can get this lawsuit back in the courts! I’m tempted to start my own research on a lawsuit. This is ridiculous had I known the problems I would have NEVER gotten them! How how can I have gotten them in 2010 and they be “safe” when, as I just found out today, the 10 yr mandatory study didn’t start until 2006?!?! How can anyone (plastic surgeon) tell me it is safe when the study wasn’t complete. I’m beyond frustrated and pray my pain goes away after I have them explanted (medical insurance is covering the cost due to it being medically necessary from the constant pain)

  15. C Reply

    I just found out that I am currently enrolled in the study after I EXPLICITLY refused consent. I am a scientist, I work in the clinical research industry and so I know all the rules and regulations and I am PISSED.
    The FDA and OIG should pursue this flagrant violation of study protocol, HIPAA compliance, patient rights, informed consent, oversight, malfeasance, negligence and fraud. I’m sure there are some Sarbanes–Oxley and anti-kick back laws violated there as well, considering that my physician was presumably paid for my participation based on fraudulent certification of consent and non-compliance.

    My devices are working fine, no adverse effects, and my doctor is already dead, but I’m not even wanting compensation as much as justice and rectification. I want them fined,and people should be fired.

    If patients are informed and say “NO. I won’t sign or fill out this questionnaire, because my privacy is more important than the $50 you are offering me. Moreover, I am paying over $6000 for this operation because I have been led to believe it is absolutely safe, not experimental or still under research. I do not want to participate in a study or any “device tracking.” -— A physician and manufacturer cannot just disregard that and include the patient anyways, against their will.

    If any lawyers want to jump on board with this, I’m ready and willing. Let’s blow the whistle.

  16. Sally Reply

    I had mastectomy and scheduled for reconstruction soon. My heart goes to those who suffered from implant side effects. I’m leaning towards saline implants after reading about your experience. If I do end up choosing silicone important, I will put my name on the FDA register and join the 10-year followup study — collective evidence can help FDA and future consumers make educated decisions, I personnal wouldn’t mind sacrifice privacy if it helps others in the future. When large portion of the implant users are not enrolled in the study, and the study results show very small % of women had side effect, the evidence of few of our cases that have serious health issues would be hard to win a law suit against implant manufacturers. (Plastic surgeon is a different case). Will update if I do choose to go with silicone and have issues.

  17. Anna Reply

    OMG When I read this ladies side affects < I feel her pain .. In 2012 My Saline implant ruptured on my left side , I was told that I should upgrade to the NEW and Improved Silicone implants , Well right away I suffered from swollen breast , fevers chills , hair loss , excessive tiredness , My chest looked deformed , My glands where swelling in my neck under my arms and i had a lump appear under my chin .. they wouldn’t Believe me that something Must be done. They should not be allow to continue putting theses implants in Women .. They are not safe NOT AT all , I have suffered so much and right Now I am looking for someone to Represent me in a law suit Against The FDA ” Stop KILLING Women .. HURTING WOMEN . They are not safe .. enough to continue doing theses cosmetic Surgeries they should be Stopped ASAP NOW before many Women die or suffer horrible side affects . they do not care about US ” Women ” humanity ” there is no Concern for our health its all about the MONEY … your being Used as Guinea PIGS Lab Rats … for MONEY its all about the big corporation . I hope and pray someone will help me fight this evil system of cosmetic surgery evil .

  18. jennifer Reply

    I am just now finding out so much information and am coming to the conclusion that the problems I have had for the past few years may indeed be from my implants I have gotten only 4 years ago. I have always been healthy and active, now I am weak, have so much joint pain which I thought was RA however I went to a Rheumatologist who ran a full work up and informed me that I do not have RA but I do have the symptoms, I was never told what I do have unfortunately, so I have kept on just researching different subjects about my symptoms and now I am finding out that it may be caused by the implants, and now I am afraid I have a leak. I will be making an appt this weak to see what can be determined. Can anyone tell me how to find out if the plastic surgeon who performed my implant surgery is involved in a study?
    Thank you and God Bless us all I pray that a resolve comes to us in our favor soon….

  19. Kathy Reply

    To Sally: I have saline implants, have had them for about 3-1/2 years and have all the immune, cardio-vascular, and neurological symptoms many of these women on this site have listed. I found out that the saline-filled implants are inside of silicone shells, which can cause all of the same problems as silicone filled implants. Do yourself a favor and research fat transplantion and stem cell augmentation. I would not go anywhere near artificial implants if I were you, or if I had to do this over. I have explantation surgery schedule in the beginning of May with a reputable doctor in Atlanta who understands this disease, how to successfully get rid of the implants and the capsule, and detox your body from the harmful metals/chemicals. I am just hanging on (took a month leave of absence from work) until my surgery. I would be willing to band together with any other women who want to file a lawsuit. I have never been litigious in my life, but what these manufacturers and the FDA are allowing to happen to women is unconscionable. I have mentor saline implants, by the way. Good luck and God bless you.

  20. Susan Reply

    It’s been 100 years since I’ve posted anything about silicone implants. I have been totally out of the loop after my testimony to the FDA in 2011. Last week I received a letter from Dr Arthur Brawer in Long Branch, NJ. Today I had the opportunity to have a conversation with him. He reached out to me because he knows and understands the link between silicone implants and major illness. He has testified to the FDA several times and has fought their use since the 1980s. He is working on a study and needs to hear from about 300 women who became ill after having silicone implant surgery- patients have to have the newer cohesive gel implants that were used since about 2000. He is hearing from and treating a new tide of women getting sick similar to when this happened in the 1980s. I have offered to participate. If this is you, please call Dr Brawer @ 732-870-3133. Susan

  21. Rebecca Reply

    I have mentor silicone June 3, 2014 & Seriously I’ll since day of surgery & getting worse. Year of Hell! Teeth have moved, infected & receding gums, disintigrating teeth, jaw bone, cognitive issues, non healing facial sores, etc. Ladies Please report to FDA online as this is only way to get this poisin pulled from market & to sue manufacturer as attorneys go to FDA site & when find Multi complaints, only then can mass lawsuits be filed. I’m Still trying to find an explant surgeon in Kansas City area to remove mine but former surgeon is telling prospective surgeons I was “fired” though Never went back to surgeon nor received a letter. I am currently trying to find attorney for malpractice. I’ve always been very active, just turned 56 & always looked way younger than my age but now have ugly smile & aged over 10 yrs in a year, face & neck sagging, NO energy, no appetite & No quality of life! SO depressed as homebound. It’s a struggle just to get thru each day. If Anyone knows of Experienced explant surgeon in or around Kansas City area, please advise & email me. I am SO desperate to get my life back! Report to FDA! !!

  22. Alisha Reply

    My inflammatory markers are high and I have been told that there are toxins in my blood attacking my nervous system. My muscles have become so weak that I am now in a wheelchair. My doctor only linked my medical issues back to my implants recently.

    I need to get my implants removed. I live in the Houston area. Does anyone know of a surgeon that removes implants due to medical problems in the Houston area?

    Thank you so much. And, thank you for sharing your stories.

    Alisha

  23. Carrie Reply

    Carrie July 2, 2015 6:19pm

    I had implants put in 1989. I was told Dow and Corning had a recall and there were so many million women to have these defective implants they went bankrupt and had no money to take care of me. My doctor tells me I can have them remove but I have to pay any additional expense for replacements or an uplift. I was unaware women were filing class action lawsuits and being told not to cash $2,000 checks and there was a deadline on February 2014 for $5,000 removal and replacement of the implants. What happened to me? Why was I not notified? Seems the Hospital and Doctor owed me the right to notify me of a recall, just like the automobile companies do for are cars. Seems a car is a big metal machine to ride you around, but must be safe and not have an accident so they are liable to contact you on all recalls. What about my body would this be medically necessary to inform me of a recall and not go bankrupt to get out of paying for lives that are in danger as the auto dealer have to by law. What do I do Now? Have I missed The Deadline because I was not informed. If you have any suggestions please share.

  24. Laura Reply

    My mother received silicone implants in the 70’s in Houston. The implants became hardened as well as as well changed shape. Se suffered a heart attack in 1993. We did not know of the relationship of the silicone to such problems. She has since gone through by-pass surgery ..Interestingly she now has seen a medical professional that believes her current issues are related to the implants. She will be undergoing many tests. I need to know if there is any way for her to receive assistance with the explant and replacement in addition to any compensation. Please share any information.

  25. Evon Reply

    Alisha in Houston, who postedon 6/30/15 Dr Steve Hamiliton is excellent plastic surgeon. Takes tome to clean up.He has done clean uponme twice after another surgeon here messed up my explant. Usuallyit isyour Internal Medicine, Rheumatologist or Neurologist who makes the implant-to-illness connection. Dr Patricia Salvato 713 961 7100 has seen many implant patients &neuro Dr Steven Inbody 713 196 0600. Best of luck

  26. Evon Reply

    Laura to your post on July 15. Heart disease is an inflammatory disease. Of course other factors can cause inflammation as well as implants. If her dr will state her implants are causing medical issues , particularly breast pain, her insurance should cover explant. The decision to replace implants is questionable given that the dr thinks they are causing problems. I am a health professional who has watched women very ill from implants for 25 yrs.Women can live excellent lives without these devices. Mastectomies, small breasts & deformities are not life threatening. Breast implants often are life alteringor life threatening. Re: compensation you don’t say what the compensation is for. If she is disabled SS disability or a private disability policy if she has it. If it is for compenstiion from implant mfg thereprobably is none for a 1970’s implant. Those weereresolved in class action& individual cases for which time for filing has expired.

  27. Evon Reply

    Carrie, 7/2/15 post. There never was a recall of Dow Corning implants. People learnedof the class action suit by way mouth, doctors, newspaper, tv, etc. No one was ever notified by the mfg. DowCorning still claims thatthere were no problems nor illnesses caused even tho it settled. Dow’s reorganization bankruptcy was only a delay tactic to sort out assets.Dow did &is continuing to pay claims for those who met enrollment deadlines.I am not a Dow supporter but the truth is the truth. Some women opted for a $2000. expedited release because they had no medical issues @ the time. This was/is perfectly legit &no reason not to cash the check. The $5,000 explant fund was for explant ONLY. It never was for replacement or uplift which could be done simultaneously at the woman’s expense unless she could find a cut-rate surgeon to perform cut rate work. A good explant with clean up is time consuming.Which brings uo the question of why would anyone want repalacement if they consider them to be harmful, in your words”deadly”. There are NO SAFE IMPLANTS. Women can lead better quality lives without these devices. There i s no elective condition ( implants post mastectomy are elective & not necessary)worth risking your general health for. The mfg helps keep the “necessity argument ” alive by claiming they help women with breast cancer when the stats for reconsruction use are low. The terms of the class action are public document in the courts as you seem to have a lot of misinformation re: the settlement. If you are ineligible then the book id moot point.You could contact theDow Settlement facility in Houston TX to make absolutely sure you have missed all deadlnes( I beleive you have). The SFDCT ph # is 866 874 6099. Your current insurance would pay for removal if you have doctor documenting that you have health related issues, breast pain, etc related to them. If they deny appeal.Excellent resources onlinefor writing insurance apeals. Go to facebook to Breat cancer survivors & Silicone Illness group for resources. Befor resources. Best of luck.

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