Belle Medical Las Vegas has always solely focused on HD Body Sculpting and Fat Transfers. That means natural Breast Augmentations and Butt Lifts using your body’s very own fat.
Recent studies have pointed out that silicone breast implants may be linked to breast cancer…
More women have been diagnosed with a deadly lymphoma caused by textured breast implants, according to a report released Wednesday from the Food and Drug Administration.
In a statement, the FDA’s Dr. Binita Ashar said there are now 457 women in the U.S. diagnosed with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), up from 414 cases in the last report. There have been more than 600 cases of BIA-ALCL, a cancer of the immune system, reported worldwide. Sixteen women have died, nine in the U.S.
The FDA, which first alerted women to the risks from the textured breast implants in 2011, also announced today that for the first time, they are sending letters to doctors, specifically primary care physicians and gynecologists, urging them to learn about ALCL so they can better diagnose and treat women who may be at risk.
ALCL patients, who have been fighting to raise more awareness of disease, applaud the FDA’s efforts to better inform physicians.NBC News Women’s Health
The History Of Implants
Congress passed the responsibility of breast implant regulation to the FDA in 1976, nearly 15 years after they were introduced to the world in 1961.
This was the first time, after 15 years of use, that the government regulated breast implant manufacturing, and even then, the attempt was a failure.
In 1988, after many safety concerns were being passed around, the FDA changed the classification of breast implants from medical devices, to Class III medical devices that required pre-market approval.
April of 1991
The FDA finally issues a final rule calling for all manufacturer’s to submit for approval on their gel-filled breast implant products.
November of 1991
After nearly 20 years of failed attempts to regulate the way silicone and gel-filled implants were being made, the Advisory Panel concluded that manufacturers of these implants had failed to provide adequate safety and effectiveness for their product.
And even then, the panel allowed the implants to remain on the market for use.
The FDA announced a voluntary moratorium (see meaning below) on silicone gel-filled breast implants, requesting that manufacturer’s stop making them, and surgeons stop using them, while the FDA reviewed the safety and effectiveness data on the implants.
A moratorium is a temporary suspension of an activity or a law until future events warrant lifting the suspension or issues regarding the activity have been resolved.NBC News Women’s Health
After reviewing, the FDA hold a second meeting to re-evaluate the safety of silicone gel-filled implants, and concludes that the implants be removed from the marketing immediately under further evaluation.
Well if that isn’t a big red-flag…
The FDA decides that silicone gel implants will only be available to patients undergoing reconstruction or women replacing their current silicone gel-filled implants, but all who receive the implants should be followed with clinical studies.
The advisory panel meets again, discussing the approval of 3 new saline-filled breast implants and recommends that the FDA approve at least 2 of the implants.
The FDA approves the first saline-filled implant from Allergan and Mentor manufacturers.
The FDA decides to approve of Mentor’s silicone gel-filled breast implants, to be used only for a limited number of patients.
Three years later in October 2003, the FDA then approves Allergan’s request for silicone gel-filled breast implants, with the same conditions as Mentor.
The FDA fully approves of both manufacturer’s silicone gel-filled implants for full use, since the ban in 1992…
However, both manufacturers were to conduct studies to prove the safety and effectiveness of their implants.
The FDA issues a safety warning on Anaplastic Large Cell Lymphoma in women with breast implants … but how many of us heard about this?
After review, the FDA then believes that women with the silicone gel-filled implants are at small risk of this cancer due to the scar capsule that is adjacent to the implant…
In March 2012, the FDA approves another manufacturer’s silicone gel-filled implant with the same conditions of proving safety and effectiveness.
The FDA is meeting again next month, to review safety of all breast implants….
Breast Implants Are Terrifying
But hey, that’s just our experience and opinion.
That’s why we specialize in Fat Transfers, rather than implants.
Our first priority is the safety and satisfaction of our patients. We use processes that we know are effective and that we believe in.
Given what you know, make the decision to research Fat Transfer before you decide on Breast Implants. You can learn more about our process by clicking the link below:
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To read more about this, head to NBCnews.com.