The Lies & MythologyThis BUSINESS INSIDER report from Reuters "Breast implants tied to increased risk of rare blood cancer" was published on the 28th January 2018, It's what is called "CHURNALISM, or a dubious press release circulated worldwide, masquerading as news. In this case, it plays down the very serious risks of breast implants raised in a recently published study. Presumably, its been published by Business Insider to keep investors on side and investing for the very high returns associated with this market. Commonly a doctor is approached for quotes, just like this one: “Breast implants remain among the most studied medical devices available in the world, and breast implant-associated anaplastic large-cell lymphoma is an extremely rare and highly treatable form of lymphoma...”
Unravelling the LIES & Busting the Myths
LIES(1) Breast implants remain among the most studied medical devices available in the world
MYTHOLOGY(2) breast implant-associated anaplastic large-cell lymphoma is an extremely rare and highly treatable form of lymphoma In 2016, a panel of French experts reviewed the safety data for textured breast implants available with a CE Mark in Europe. GUESS WHAT? THERE IS NO SAFETY DATA ON FILE FOR TEXTURED IMPLANTS! Where's the evidence for our claim? Please refer enquires to the French National Regulating Authorities ANSM. And Fig1 shown below. The "most studied" suggests evidence of safety, where in fact there is none.
But What About the BIG manufacturer studies?
In January 2004, the FDA found that Inamed (Allergan) had failed to provide long-term safety data on silicone gel-filled breast implants. Implant companies have now had 18 years to collect long-term data on implant patients. The problem is always the same: too many implant patients dropped out of the studies or, more accurately in our view, the companies failed to carry out an effective surveillance of implant patients. We know that many women who had complications attempted to report these to their doctors and to the companies and were not taken seriously. Records became "lost."
It is unacceptable that again a substantial number of the 40,000 patients that Mentor and Allergan were required to track were "lost" in just a very short time frame. Mentor had lost track of 79 percent of all patients within three years of their enrollment and Allergan lost track of almost half of their augmentation patients within their first two years, along with 25-31 percent of their reconstruction patients in that same length of time. Such a high loss to follow-up completely undermines the value of any findings.
The Keller FunnelStill Allergan found and bought a solution. Its called a Keller Funnel : its a device that looks like a piping bag, it means the implant doesnt need to be touched during surgery and thereby reduces contamination of the implant. Read More on Keller Funnel bought by Allergan
BetadineAlso, surgeons now have access to Betadine (formerly BANNED due to known carcinogenicity, but now BACK in USE to reduce surgeon liability for implant contamination. YEP BETADINE IS CARCINOGENIC and was BANNED for use with implants until 2017. An interesting read on Betadine in an earlier chapter of concern over breast implants Thomas C. Wiener; Betadine and Breast Implants: An Update, Aesthetic Surgery Journal, Volume 33, Issue 4, 1 May 2013, Pages 615–617, https://doi.org/10.1177/1090820X13484036 Here is the decision approval statement from the FDA, dated August 2017, for Allergan Saline implants.
Approval Order Statement Approval for changes to the labeling including 1) the removal of the Betadine warning against breast implant exposure to Betadine brand povidone-iodine 10% (applicable to generic versions as well) from the patient and physician labeling, and 2) modifications to the language in the physician and patient labeling regarding the potential risk of breast implant associated anaplastic large cell lymphoma (BIA-ALCL).Does use extend to silicone breast implants? The approval order only mentions saline implants.