IN RESEARCH ‘BIG INDUSTRY’ GETS THE RESULTS THEY PAY FOR … which is not necessarily reflective of the TRUTH. And certainly not the WHOLE TRUTH.
Think tobacco, asbestos, and other such controversial substances where in the end truth prevailed after long, hard won fights. Industry buried damning studies, falsified documents, bought off researchers, regulators and medical practitioners, discredited whistleblowers, and engaged in other despicable actions.
The breast implant industry is no exception. Author, Gail Hamilton, wrote a great book called, ‘Breast Implants and the D.I.R.T. Committee’ which exposed the dirty dealings of Dow Corning and their efforts to bury evidence and falsify records.
In 2006 FDA ‘conditionally’ re-approved silicone breast implants after a 10-year moratorium. Manufacturers were to conduct ‘long term’ studies of 10 years to prove ‘safety’.
THERE IS GREAT CAUSE FOR CONCERN BASED ON PAST, AND PRESENT, TRACK RECORDS OF BOTH MANUFACTURERS AND FDA
MORE FLAWED STUDY RESULTS
In the conditional studies conducted between 2006 to 2016 ‘core studies’ were terminated early, while other studies were not completed or had low patient follow-up. Women that presented with complications or health complaints were dropped. As in the past where study results were not reflective of the truth of the dangers of breast implants, we are likely set for the same injustice to be repeated.
CONFLICT OF INTEREST
BREAST IMPLANT MANUFACTURERS ARE FUNDING STUDIES INTO BREAST IMPLANT SAFETY, including the role textured implants play in Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).
Advocates and watchdogs believe there is another massive cover-up playing out.
Recent international media attention over Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) has led to a flurry of accelerated research. This story has plagued the industry thanks to those who continue to keep the issue alive despite industry efforts to downplay and bury it.
Research focus is on the role of bio-contamination in leading to BIA-ALCL.
There will no doubt be really good things come of research into biofilms. For starters, biofilms are now publicly acknowledged as being a serious health problem with implantable medical devices. It confirms that biofilms make patients sick, though manufactures and regulatory bodies largely disassociated illness as being from implants till now. It also evidences that biofilms lead to chronic inflammation, autoimmune illness, and cancer. Again, this is a step forward and should markedly improve patient safety despite it likely being a calculated industry move vs a revelation.
Research has led to development of the ’14 Point Plan’ aimed at mitigating bio-contamination at the time of surgery when placing breast implants in a patient. The researcher behind it, who’s motto is ‘patient safety before profit’, Dr Anand Deva, is calling for life-long follow-up of breast implant patients, which is decades overdue. And new, allegedly more reliable tests for detecting inflammation and infection are in the works. *Please note: A link to a video of the ’14 Point Plan’ is included at the end of this blog piece.*
Some researchers claim BIA-ALCL, a cancer of the immune system, can be eradicated through safe surgical practices. Given textured breast implants are thought to be exclusively linked to BIA-ALCL it would seem the most assured route to eradicating it would be to stop using textured breast implants.
WHY DID IT TAKE DEATHS TO MOVE THE INDUSTRY INTO ACTION?
It should be questioned WHY breast implant manufacturers and FDA waited until there were confirmed deaths related to BIA-ALCL before taking action. More specifically, it should be questioned WHY it took unwanted international media attention to move them into action. Damage control.
Researchers have been raising the alarm over biofilms and inflammation for the past 20 years, urging manufacturers to give this more focus.
Since breast implants were introduced to the consumer market in the early 60’s women have become ill in the same ways, with the same basic set of illness manifestation. Despite this overwhelming REAL WORLD EVIDENCE manufacturers, regulating bodies and the medical profession insisted categorically breast implants were unrelated to these illnesses. Women were discounted as ‘NUTS’ and referred to psychiatrists.
NOW there’s industry admission that biofilms have been making women very sick, and its led to deaths.
Altruism doesn’t come to mind as being synonymous with the breast implant industry. They make calculated, industry-serving decisions.
We should question why all of a sudden the industry is willing to make the concession of biofilms. They’ve known for decades. What makes it worth it for them to finally admit it? What are they hiding? What would be even more damning to their industry?
The ELEPHANT IN THE ROOM .. TOXIC CHEMICALS and MIGRATED SILICONE.
MANUFACTURERS ARE NOT FUNDING RESEARCH INTO THE ROLE CHEMICALS PLAY in the development of BIA-ALCL. Rather than look at their devices, they’re looking to place blame for the failure of their devices and the serious harm they cause on an external entity. IMHO, this is a SMOKE SCREEN.
Will research into biofilms save lives and improve patient outcomes with implantable devices .. I hope so. Will it eradicate all harmful health issues related to breast implants, including BIA-ALCL .. my belief is categorically, NO.
Breast implants will continue to bleed harmful chemicals into women’s bodies. Silicone will continue to migrate. The toxic chemicals in breast implants will continue causing serious illnesses and deaths.
Silicone imbedded in lymph nodes, tissue, muscles, vital organs cannot be washed off, or removed without excision of whatever its embedded in. Even worse, it can be impossible to remove all migrated silicone. A prominent explant surgeon commented in one of her videos that she has to be careful not to get silicone on the floor because the floor would have to be stripped. Holding a ruptured breast implant she’d removed she described the toxic silicone burning her face and eyes (a comment typically made by women when they hold their explanted devices).
An autopsy done on a Danish woman showed that she had silicone in virtually every part of her body from gel bleed, including vital organs. Her implants were not ruptured.
Silicone migration is NOT ‘rare’ as confirmed by the more than 25,000+ women in breast implant illness support forums. Most of us have confirmed lymph node involvement.
Silicone in breast implants creates acute inflammation specific to implants. The inflammation is manmade and doesn’t occur outside of silicone in breast implants.
Continued denial of the role toxic chemicals play in developing autoimmune and neurological illness, cancer, and other health manifestations is a continued crime against humanity.
Disassociating toxic chemicals that flake off textured surfaces and the development of BIA-ALCL is a predictable conclusion when breast implant manufacturers are funding the studies. When they won’t even explore the role chemicals play nothing more needs to be said. We should all be concerned about the outcome of this ‘research’.
** Those interested in breast implant safety and the upcoming regulatory decision in 2018 regarding licensing of silicone breast implants should be paying close attention. Now’s the time to act to protect more women from being unnecessarily harmed. We must continue pressuring manufacturers, regulating bodies and government with a unified international voice. **
Video: ’14 Point Plan’