NOV 22, 2017 02:49 PM PST
FDA Cautions Against Injectable Silicone Use
WRITTEN BY: Carmen Leitch
2 1 238

In recent years there have been a number of arrests related to the unlicensed application of silicone to various parts of people’s bodies. Many people have experienced adverse medical events after receiving silicone injections; their symptoms are irreversible. The U.S. Food and Drug Administration has now issued a warning to consumers; they want people to avoid injectable silicone or products sold as dermal fillers for the enhancement of the body. Use of these products can cause severe injuries and disfigurement.

“An important part of our public health mission is our obligation to warn consumers of unapproved products that are being marketed for medical uses that can cause serious harm. We have significant concerns with unsafe injectable silicone that’s being marketed for body contouring by unlicensed providers. We’ve seen serious adverse events result from products, which are sometimes industrial-grade silicone, being used for these unapproved medical purposes,” said FDA Commissioner Scott Gottlieb, M.D. “The FDA has stepped in to take enforcement actions against unscrupulous actors who promote and provide these services, but we also want to make the public aware of the risks, which can include irreversible disfigurement and even death. While we’ll continue to go after those who provide these unlawful services, the FDA will have its greatest impact by educating Americans to avoid these unsafe practices.”

The injectable silicone used for body contouring is not approved by the FDA; it’s different from silicone used in approved breast implants. The FDA has not approved injectable silicone except in one very specific instance inside the eye; they have not approved it for any kind of body contouring. When silicone is injected in an attempt to change the curves of the body, it stays in the body forever and can lead to death. Reactions range from mild scarring to tissue death and disfigurement. The silicone can migrate away from the site of injection and can then block blood vessels. That can lead to a stroke or infections. Complications from silicone injections can develop rapidly, or over years.

The FDA has not approved any silicone injections for body contouring. / Image credit: Maxpixel

“The FDA is alarmed by the increasing trend of injectable silicone being used for body contouring purposes,” said Melinda Plaisier, associate commissioner for regulatory affairs at the FDA. “The agency has investigated and prosecuted unlicensed providers administering these injections all over the country, including most recently in Miami. In addition to prosecuting the criminals who take advantage of consumers, the FDA is taking action to educate consumers in order to prevent the serious injuries resulting from these injections. With our communication today, we hope to raise public awareness about the short- and long-term risks of injecting silicone directly into the body, and encourage consumers to choose FDA-approved products and licensed providers when considering any type of cosmetic enhancement.”

If someone who has gotten these injections has trouble breathing or speaking, numbness, weakness or difficulty walking or confusion, they are encouraged to see medical attention immediately. The FDA suggests that anyone considering such a procedure speak with a doctor first about the risks. The FDA has a checklist for consumers to review which helps with the selection of products of providers for cosmetic enhancement, Check Before You Inject.


Source: FDA

About the Author
  • Experienced research scientist and technical expert...
You May Also Like
APR 24, 2018
Cancer
APR 24, 2018
Synthetic Retinoid Shows Promise for Inhibition of Cancer Cells
Researchers studied the potential use of a synthetic retinoid, WYC-209, as an inhibitor of cancer cell growth and metastasis via the retinoic acid receptor pathway.
APR 25, 2018
Genetics & Genomics
APR 25, 2018
Advances in Cancer Research Through Organoids
Researchers have been using a new tool in biomedical research to more closely mimic human biology - mini models of human organs, called organoids.
APR 25, 2018
Cancer
APR 25, 2018
Artificial Mole Tattoo for Early Cancer Detection
Researchers are looking to biotechnology to enhance the detection of diseases including cancer. A group utilized the consistent presence of long-term hypercalcemia to detect early cancer.
MAY 18, 2018
Cell & Molecular Biology
MAY 18, 2018
Likely Cause of Polycystic Ovarian Syndrome ID'ed
Polycystic ovary syndrome is a leading cause of infertility in women and can be a cause of miscarriage. Now research has found a possible cause.
MAY 31, 2018
Technology
MAY 31, 2018
PUREGRIP: Safe, User-Friendly Bottles for Biomedical Research
Foxx Life Sciences and Borosil Glass Works Joined up to Create a Lab Bottle Breakthrough
JUN 08, 2018
Videos
JUN 08, 2018
The Molecular Machinery of the Cell in Action
Cell division, also referred to as mitosis, is a critical process that keeps us alive. It has now been animated in detail.
Loading Comments...