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Silicone Breast Implant Lawsuit Filed Over Problems with Allergan Natrelle

  • Written by: Irvin Jackson
  • 15 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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15 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.

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