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Women Should Not Use Silicone Breast Implants: Public Citizen

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Public Citizen, a consumer watchdog group, indicates that the FDA did not go far enough in warning women about the risks associated with silicone breast implants last week, suggesting that women should be advised against having the implants. 

Last week, on June 22, the FDA issued new safety data for silicone breast implants, indicating that the agency has found no link between the breast implants and breast cancer.

Although the agency said that the silicone implants have a “reasonable assurance of safety”, they also indidicated that “the longer a woman has (silicone) breast implants, the more likely she is to experience local complications or adverse outcomes.”

In a statement released last week, Public Citizen called the agency’s stance shortsighted and contradictory.

The FDA has acknowledged that while there appears to be no link to breast cancer, there are other common side effects and complications with silicone breast implants, such as ruptures, scarring, tightening of the skin around the implant, pain and infections. Despite these problems, the agency has determined that silicone implants are safe and effective when used properly, but the FDA is continuing to gather data.

In 2006, the FDA allowed silicone gel-filled breast implants to return to the market after having requiring a silicone breast implant recall in 1992 due to a failure by manufacturers, Allergan and Mentor Corp.,  to turn over requested clinical trial data and suspicions that the implants could cause breast cancer. The FDA’s subsequent studies found no links to breast cancer and the manufacturers turned over preliminary trial data, paving the way for their return to the market.

Breast implant manufacturers have complained that they have had trouble keeping women enrolled in silicone breast implant studies, and last week the FDA urged women to remain a part of those studies so that the effects of silicone breast implants over long-term use could be better understood.

Public Citizen has opposed the re-approval of silicone breast implants, arguing that the FDA’s lack of data and the reliance on post-marketing observation of women who have received breast implants makes the return of silicone breast implants to the market resemble an experiment on women. The group also pointed out that the report comes just months after the FDA warned that both silicone and saline breast implants could be linked to lymphoma.

In January, 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. Shortly after the FDA issued the warning, the American Society of Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS) put up an online video, called a webinar, that appeared to many critics to be urging plastic surgeons to downplay the FDA warning and avoid using the word cancer.

A concerned plastic surgeon sent Public Citizen a transcript of the webinar, during which ASPS President Dr. Phil Haeck said plastic surgeons were justified in “downplaying” the malignant potential of ALCL tumors. The webinar also instructed plastic surgeons to tell patients that cancer surgery was curative, which Public Citizen says is inaccurate. Public Citizen expressed concerns and called on the FDA to take action. The information was taken down after the FDA contacted the two groups.

Public Citizen said that the incident highlights concerns that women who participate in studies or receive breast implants may not be adequately educated enough to provide informed consent.

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9 comments

  1. Wanda Reply

    Hello
    I have had siicon breast implants since June 0f 1981, I used to have some redness around the nipple and sorenes before menstration. I don’t have those symptoms any longer. I’m not sure if there is any leakage or not but they are soft and still the same shape they were at implantation.

    I would certainly like to be part of this study since my implants are 30 years old.

  2. Ruthie Reply

    Silicone information

    http://www.webstarmagic.com/smoke_fire/documents_1-50.htm

    Here is a some of the study, note that they say “The question of why materials with diverse surface properties elicit the same FBR has troubled investigators for more than two decades.

    Soft tissue implants elicit a host response that normally leads to their encapsulation by an avascular collagenous capsule (1). This multistep process, termed the foreign body reaction (FBR), is characterized by a transient acute inflammatory reaction followed by formation of granulation tissue and fibrosis and is clearly related to the biocompatibility of inert materials. Thus capsule formation has been linked to diminished implant performance, often with subsequent failure (2). Consider, for example, implanted electrodes, drug delivery devices, and breast implants, all of which are compromised by capsule formation. The question of why materials with diverse surface properties elicit the same FBR has troubled investigators for more than two decades (3–5). It is believed that implants acquire a protein coat immediately after implantation, which serves as a stimulus for the development of the FBR (6–10), and it has been suggested that fibrinogen is a critical component of this protein coat (10, 11). Adsorption of proteins can be influenced by the surface properties of the material and may lead to modification of the FBR (3, 12–15). It has been suggested that, if all other properties and conditions are equal, materials with hydrophilic surfaces elicit less of an inflammatory response when compared with materials that have surfaces with hydrophobic properties (16).

    Read more from this study!
    http://www.jstor.org/pss/47586

  3. Nicole Reply

    The FDA should never have approved the reintroduction of silicone implants. They can make some women very sick with a number of
    neurological symptoms. The most frustrating part of silicone syndrome is that plastic surgeons are telling women who have had breast cancer they are safe. This is every bit as sinister as what was done to the african americans in the Tuskegee studies. The worst part about it is that because of the lack of accurate research an ill woman will go from doctor to doctor with no diagnosis- all the time her health is declining. I know -silicone has ruined the last two years of my life. Five days after I had them removed I saw relief in the unexplained anxiety that I had for a year. I am currently recovering from tinnitus and visual abnormalities. This is amazing that this can go on in the United States- shame on congress, shame on plastic surgeons,shame on general practitioners who ignore their patients who tell them their own personal experiences with suffering. The only way women have help is through each other and a handful of doctors that take them out when they get sick.

  4. Ellen Reply

    I hope the woman who had implants for 30 years has an MRI.
    Miy 20 year old 1984 silicone (double lumen) implants were ruptured for about 5 years before I realized it. By that time, I had been diagnosed with MS, lupus, and Hashimoto’s (thyroid) disease. Thyroid disease is not uncommon with middle aged women but multiple autoimmune disease is. The diagnoses were not based merely on reports, but on many lab tests and cliinical evaluations. I recognize this is an anecdote – eg just my experience, but when I had the implants removed (and not replaced) by a surgeon specializing in this area, the majority of my symptoms went away within a year. Coincidence? Possibly, but I don’t see other variables that changed. I went through hell and back, and at one point, even my doctor thought I was going to die. I didn’t and my health is much better than it was, but I believe that had i not removed the implants, I would be dead now.
    There is a real danger that the plastic surgeons who financially benefit are making the calls as to implant safety. Doctors often react so flippantly to the suggestion that implants may cause these problems, that I rarely mention it anymore. By chance I found a rheumatologist at the university that does believe there can be a connection and was in my case. Logically, does it make any sense that implant would not pose a major risik? I think not.
    I am not looking for legal assistance. I am an engineer and attorney, and tended to scoff at the lawsuits in the 90s. I do not do so anymore. Because I had never registered for the class action lawsuit, I was a “late registrant” but still received an MDL payout for lupus. I was that sick.

  5. Susan Reply

    I had a subcutaneous mastectomy in August 2010, with immediate reconstruction using Mentor MetroGel silicone implants. I have had multiple infections and capsular contracture requiring 5 surgeries inside of 18 months. I now have joint pain (shoulders, knees, ankles, hands and feet). My feet hurt SO bad that I want to cry! This pain is increasing daily! I am going through a divorce and will soon have no health insurance. What can I do? PLEASE. . . someone help me!

  6. Mairi Reply

    Please google Mairi Johnston Silicone Breast Implant Rupture Awareness to see my Petition PE 1378 which reached the highest level at the Scottish Parliament.
    My Campaign and Petition material can be available by request if you leave me your email address. I have been a victim of ruptured silicone breast implants twice, have silicone lodged in my major organs and now suspect I have AlCL cancer
    Non recognition of rupture dangers is the crux, as without that there is no care, treatment and justice. A scandal and holocaust indeed!

  7. Tracey Reply

    I had silicone implants in May 2009. I started to get very sick in Nov 2012. My plastic surgeon told me I had something wrong with me but there was no way it could be the implants because “these implants dont leak” He treated me as if i was crazy. This came after a biopsy with a diagnosis of Silicone in my lymph nodes (Axilla) I have since had to have a bilateral partial mastectomy and have had medical issues since. When my implants were removed my left implant had two large tears in it. I would not suggest silicone implants to anyone!! Dont listen to the plastic surgeons

  8. Britania Reply

    I’m 26 years old and am constantly ( jokingly) but pretty accurately called ” grandma” by my friends. I got mentor gel silicone implants about 2.5 years ago and it has completely ruined my life. I’m trying so hard to save the money to get an enbloc removal. I know with everything in me it is the implants that made me sick. I went from a super athletic outgoing full time model to a depressed, sick, in debt because i can’t stand on my feet long enough to even work. My skin broke out in a lupus type rash on my face. My hair thinned and falls out in patches. It’s hard to even type this my hands hurt so bad. I constantly cry myself to sleep in pain. I see a rheumotologist who specialized in females who have developed in auto immune like disorders from implants. Dr. Daniel Arkfeld at USC rheumotology literally saved my life. I had been in bed for 7 weeks I couldn’t even get up to urinate but was too proud to tell anyone until I woke up ont he ground from what now is being thought was a seizure. Friends and partners cant stand to be around me.. hell i cant stand it. I have hypertension, kidney disease, joints like to all swell up big and turn purple i get bruise like lesions about 6 inches or bigger around my legs and bum. Rashes and hives very easily. Not to mention I lose 30 pounds in “Flairs” and then gain back in “remissions” I black out a lot.. and literally don’t know what to do anymore. I know I need them out but when you’re so sick that you literally cannot stand longer than a few hours without complete body pain how are oyu supposed to live? Tomorrow I’ll be getting x rays because I just developed masses all over my body in my neck and hips im assuming are my lymphnodes but they are very big hard and painful.. Being on around 7-12 pills of meds a day, trigger point shots, all kinds of steroids, and the worst are the big cortasone shots in the knees that only makes you walk for 3 weeks until im back to square one. I was too proud to tell anyone I was sick. I got sick right after my impants and its years later and I can’t imagine this much pain withouth an unwelcomed ending coming soon.

  9. Patty Reply

    In 2006, I had a bilateral mastectomy due to breast cancer. The plastic surgeon that did my reconstruction talked me into joining the Mentor study. I told him I was interested in saline. He informed me that mastectomy patients couldn’t use saline because it would be too sloshy and have ripples due to the fact there was no breast tissue. The plastic surgeon said that silicone implants were now safer and the Mentor gel implants were “self sealing.” He informed me that I would not have to pay for the implants if I joined the study. Since I was a single mom and had just paid off medical bills from thyroid cancer 2 years prior, I was the perfect candidate. 9 years later, May 29, 2015 I had them removed. They were in deplorable condition – not just ruptured. There are pieces missing from around edges on both of them. The surgeon that removed them said they are the worst he has ever seen. Pathology is holding them for me and also reported they are worst they have ever seen. I called mentor to tell them of my outcome and they refused my information. I met three other women on Facebook that said they had feedback from Mentor. Very strange thing is, they have no serial number on them. They have a model number, but no serial number. I have all the same symptoms every other women with silicone in their system has. And, it’s in my lymph nodes. I found one attorney that represents men that have silicosis from their job sites. Funny thing, men have health issues with silicone, but apparently, its perfectly harmless for women. (Sarcasm)

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