Breast Implant Illness Risk Not Seen By FDA Based on Current Evidence

  • Written by: Irvin Jackson

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Despite mounting complaints raised by a growing number of women nationwide, federal regulators indicate they are not yet aware of any evidence linking cases of wide-ranging illnesses to breast implants. 

In a report this week by in Arkansas, problems experienced by women after receiving artificial breast implants were outlined, describing the seriousness of “breast implant illness”.

Women experiencing breast implant illness describe chronic side effects, such as fatigue, cognitive problems, muscle and joint pain, hair loss, infections, gastrointestinal problems, rashes and thyroid issues. In many cases, the problems have led women to have their breast implants removed, and concerns about the risk have become a factor many are questioning when deciding whether to undergo breast enhancement or reconstruction surgery.

While the FDA and the medical community have acknowledged the risk of breast implant ruptures and leaks, and, more recently, a form of lymphoma found to develop in the tissue surrounding breast implants, the larger breast implant syndrome risk has not yet been recognized.

According to a statement provided in the report, the FDA indicates that with the exception of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), the agency does not have evidence that establishes a connection between breast implants and a wider range of illnesses.

A growing number of women and consumer groups are continuing to raise concerns about the issues, including the website and a number of social media groups.

Most doctors still do not review the potential risk of breast implant illness with patients, since it is not a recognized medical condition and there have been no studies to establish that it exists. However, science often takes time to catch up with the fast pace of emerging health risks that may appear on the internet and social media.

Last year, the FDA issued warnings about breast implant lymphoma rates, long after concerns about the risks first emerged. A number of subsequent studies have confirmed that the cancer risk is real, and suggest that it may be linked specifically to the use of certain textured breast implants with larger surface areas.

In June 2017, a 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 Surgerywarned that many breast implant cancer cases worldwide have likely not been reported, and noted that many doctors continue to be unaware of the BIA-ALCL risk.

As awareness of the problem increases, many experts have warned that the number of diagnosed breast implant ALCL cancer cases is likely to increase. As a result of manufacturers’ failure to adequately research the risks associated with their devices, a number of women are now pursuing potential breast implant cancer lawsuits, and it is possible that breast implant illness claims may also be pursued if independent scientific evidence emerges to support the claims.

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  1. Valerie Reply

    I am confused…if the FDA is hiding study data off of their site, negligent with their own compliance and bending their rules in favor of pharma companies (this is just a start), then how can any fool trust anything the FDA says or more importantly, what they DON’T say? Science needs “to catch up”? You mean the decades of medical journal articles and deaths associated from breast implants isn’t enough thus far? Please get your facts straight before you publish false facts and incorrect information. It is really not that hard to research breast implant illness and you should try it next time before you write on it.

  2. Meg Reply

    In Jan 2013 I had allergen smooth gummy silicone implants. Left one encapsulated and ruptured 2years after. When explanted it was a dark green in color and full of fungus. Had many issues before explant. They are now slowly getting better. Not sure I will ever be the same. Very disappointed.

  3. Tracy Reply

    I am an explant 2002. Breast implant lymphoma survivor. It ruined my life and my family thought I was crazy. Ruined my family relationships, financially ruined. Lost my 25 year career trying to afford everything and get the toxic bags out of me. The doctors that put these in and the companies that make them should burn in eternal hell. I don’t see the magnitude of this in the penile implant cases.
    Please help all the women you can ❤️

  4. Pamela Reply

    I had Mentor implants put in 1999, had a rupture in 2003 from mammogram. Went to P.S. he told me he would not replace one even with a lifetime warranty. He wanted to replace both. I could not afford that. He said leaving it in will be fine. He even told me that he has had women rupture the other on their own to match. He would not help me. So in 2017 December I could not take pain the way I was feeling it, I wanted anything inside of me out that did not belong. I explanted 2017, December. The Burning and fire in my chest stopped, but nothing else has. Having an endo- neuro surgeon doing all labs and MRI’S. Head is on fire , losing hair by the handful. The explant doctor ruptured the intact implant still in me by stabbing it, and my implants were under the muscle. I have all my records, When they were put in , when I went to see P.S. when ruptured. What he was going to charge to fix. And all my explant info. I had to go back on the side that was stabbed for second surgery. Infection set in, green stuff was pouring out my tubes. I told them I wanted my implants, and info. I got the info, guess I will have to go get the implants myself. I know they were ruptured by I told them to take a picture at the time of surgery. So I should get a picture for sure. I was never told not to get a mammogram because of the chance of rupture. I was never told I would need to replace them in 8 – 10 years. I was never told I would get sick, if they ruptured, In fact I was told the opposite. Now I am disabled with a lung disease. I do not know everything that’s wrong yet. I had a hair analysis done, came back” aluminum toxicity ” poisoning in my blood , liver , kidneys , lungs. So having more nerve, and muscle testing done as well. I will know by the end of the year what all is wrong. Lab test shown results , of HEAVY GROWTH , CONNECTIVE TISSUE , WHITE BLOOD CELLS ECCESSIVE, STAPHACOCULAS PRESENT.

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