SILVER SPRING, Maryland, Nov. 14, 2017 /PRNewswire-HISPANIC PR WIRE/ — The U.S. Food and Drug Administration today issued a safety communication to warn consumers and health care practitioners about the serious injuries and disfigurement that can result from using injectable silicone or products being falsely marketed as FDA-approved dermal fillers for the purpose of enhancing the size of their buttocks, breasts and other body parts.

“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.”

Injectable silicone is different from the silicone contained within approved breast implants, because the breast implant shell keeps the silicone from migrating within the body. Injectable silicone is currently only approved by the FDA for a specific use inside the eye (intraocular ophthalmic use). When seeking to enlarge the size of their buttocks or breasts, or other large-scale body contouring procedures, some consumers are falsely told they are receiving an FDA-approved dermal filler, but are actually injected with silicone.

Consumers need to be aware that injectable silicone used for body contouring is not FDA-approved and can cause serious side effects that may be permanent or may even lead to death. Side effects can include ongoing pain and serious injuries, such as scarring, tissue death, and permanent disfigurement; if the silicone migrates beyond the injection site, it could cause an embolism (blockage of a blood vessel), stroke, infections and death. Serious complications may occur right away or could develop weeks, months, or years later.

Silicone injections for body contouring are often performed by unlicensed and non-medical practitioners in non-clinical settings such as residential homes or hotels. The FDA does not know the true extent of these injuries caused by these procedures because unlicensed practitioners do not report injuries incurred from their illegal practice and patients who are harmed may not know to alert the FDA.

“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.”

The FDA has participated in a number of criminal enforcement actions in recent years that resulted in the arrest and sentencing of unlicensed practitioners who illegally used these unapproved injections on patients. Two Miami spa owners were arrested in February and recently sentenced to four and six years in prison for managing a spa that performed illegal silicone injections. Hundreds of clients received illegal buttock injections and many experienced irreversible injuries and symptoms as a result of the silicone migrating through their body.

The FDA encourages consumers who may have received injectable silicone to seek medical attention immediately if they experience problems such as difficulty breathing, chest pain, signs of a stroke (including sudden difficulty speaking, numbness or weakness in the face, arms, or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), as it may be a life-threatening situation. For those who are considering a body contouring procedure, talk with a health care provider about appropriate treatment options and the risks associated with the procedure. Consumers are encouraged to review the FDA’s Check Before You Inject checklist for helpful information on choosing FDA-approved products and licensed providers for cosmetic enhancement.

Those who have been offered or have received injectable silicone for body contouring from an unlicensed provider are encouraged to use the FDA website to Report Suspected Criminal Activity.

For more information:

• Safety Communication: FDA Warns Against Use of Injectable Silicone for Body Contouring
• Consumer Update: FDA Warns Against Injectable Silicone for Body Contouring and Enhancement
• Video: FDA Warns Against Injectable Silicone for Body Contouring and Enhancement
• Check Before You Inject checklist

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Stephanie Caccomo, 301-348-1956, [email protected]  
Consumer Inquiries: 888-INFO-FDA

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SOURCE U.S. Food and Drug Administration

Grant focuses on supporting school districts and community organizations working to create healthy school environments.

WASHINGTON, Nov. 13, 2017 /PRNewswire-HISPANIC PR WIRE/ — America’s Promise Alliance, the nation’s largest network dedicated to improving the lives of children and youth, is extending the Healthy Schools Fund to communities working to create healthier school environments for all children.

As part of Together for Healthy and Successful Schools, a new initiative of the Robert Wood Johnson Foundation (RWJF), America’s Promise will select three to five districts and/or community-level organizations that will receive up to $300,000 for two years to support existing collaborative efforts.

Through this work, America’s Promise seeks to answer the following questions:

What if every young person went to a school that focuses on academics as well as social and emotional development and physical health? How do we create the conditions to make it so all children, no matter where they are from, or how much money their family makes, has access to a school that helps them develop into well-rounded adults?

Recognizing that school-centered health intersects with many areas outside of education—housing, employment, transportation, and food access— efforts should serve as a hub for cross-sector collaboration, youth and community engagement, and broader policy and systemic change. Selected grantees will display alignment with this vision and a proven ability to accelerate positive change for young people in schools and their communities.

“America’s Promise has always believed that to support young people who are struggling the most, it takes approaches that focus on all of a child’s developmental needs,” said John Gomperts, president and CEO of America’s Promise. “When communities have healthy schools young people experience greater health, achieve better academic outcomes, and in turn, impact the entire community. Our partnership with RWJF will enable us to help build demand among practitioners, community members, and decision-makers to make healthy schools the norm and create the conditions for every child to have a healthy, successful life.”

Districts and organizations in the following 20 states are eligible to apply: Alaska, California, Colorado, District of Columbia, Florida, Idaho, Indiana, Michigan, Mississippi, Missouri, Nevada, New Jersey, New Mexico, New York, North Dakota, Oregon, Rhode Island, South Carolina, Texas, and Washington. 

“To ensure all young people can seize educational opportunities, they need to be at their healthiest,” said Jennifer Ng’andu, senior program officer at RWJF. “Research shows that healthy, nurturing, and safe schools help young people make the most of their education and that success leads to a healthier, longer, more successful life. RWJF launched the Together for Healthy and Successful Schools initiative in recognition of the critical connections between health, learning and long-term well-being.”

To learn more about the America’s Promise Healthy Schools Fund and to apply, visit www.americaspromise.org/healthy-schools-fund. Informational sessions about the grant will take place on November 28 and December 7.  The deadline to submit applications is January 22, 2018.

America’s Promise Alliance’s Partnership with RWJF to Support Healthy Schools

America’s Promise Alliance is offering the America’s Promise Healthy Schools Fund as a result of its grant award to lead the strategic action and alignment arm of the Together for Healthy and Successful Schools initiative.

Funded by the Robert Wood Johnson Foundation, the initiative has the goal of advancing a more holistic approach to ensuring healthy, successful students; thriving communities; and a better future for everyone. America’s Promise will work closely with its fellow grantees—Child Trends and Washington University in St. Louis – which are leading the policy and research arms of the initiative, respectively.

In its role, America’s Promise will activate and align existing and new stakeholders at both the local and national levels to support and build demand for healthier schools. America’s Promise has partnered with five leading organizations – ChildObesity180, Communities In Schools, FoodCorps, the National Association of Community Health Centers, and Turnaround for Children – to provide support and work with communities to learn about successfully supporting health and well-being in schools.

For more information, please email [email protected]

America’s Promise Alliance leads more than 450 organizations, communities and individuals dedicated to making the promise of America real for every child. For more information, visit www.AmericasPromise.org.  

Media Contact: Tonya Williams
[email protected] 
202-657-0644

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SOURCE America’s Promise Alliance