La Administración de Alimentos y Drogas de los Estados Unidos (FDA) aprobó hoy los implantes de seno rellenos de gel de silicona fabricados por Sientra Inc. para aumentar el tamaño del seno (aumentación) en las mujeres por lo menos 22 años de edad y para reconstruir el tejido de los senos (reconstrucción) en las mujeres de cualquier edad.
FDA approves new silicone gel-filled breast implant
Today, the U.S. Food and Drug Administration approved a silicone gel-filled breast implant manufactured by Sientra Inc. to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age.
As a condition of approval, Sientra is required to conduct post-approval studies that will assess long-term safety and effectiveness outcomes as well as the risks of rare disease outcomes.
FDA approves first cell-based product to treat oral mucogingival conditions in adults
The Food and Drug Administration today approved GINTUIT, the first cell-based product made from allogeneic human cells (from a donor unrelated to the patient) and bovine collagen. GINTUIT is indicated for topical (non-submerged) application to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults.
Cargill Animal Nutrition Conducts Regional Recall of Nutrena NatureWise Goat Pellets
Cargill Animal Nutrition today announced a voluntary and limited regional recall of Nutrena NatureWise Goat Pellets due to an error in labeling. The bags of affected goat feed should have indicated that the feed included Decoquinate, a medicated article for the prevention of coccidiossis that is commonly included in ruminant feed, but which is not approved for lactating goats.
Gerber Voluntarily Withdraws a Specific Batch of Gerber Good Start Infant Formula and Offers Replacement Product to Consumers
Gerber Products Company is proactively retrieving and offering a replacement to consumers who purchased Gerber Good Start Gentle powdered infant formula 23.2 ounce plastic package from batch GXP1684 expiration date of March 5, 2013. The product poses no health or safety risk.
Gerber Voluntarily Withdraws a Specific Batch of Gerber® Good Start® Infant Formula and Offers Replacement Product to Consumers
Gerber Products Company is proactively retrieving and offering a replacement to consumers who purchased Gerber® Good Start® Gentle powdered infant formula 23.2 ounce plastic package from batch GXP1684 expiration date of March 5, 2013. The product poses no health or safety risk.
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FDA Commissioner Margaret A. Hamburg’s Statement on the Surgeon General’s Report
Tobacco use is the leading cause of preventable death in our nation. And until we dramatically decrease the access and appeal of tobacco products to youth, it will remain one of America’s most pressing health problems. Today’s ground-breaking report by the Surgeon General not only documents the devastating consequences of tobacco use for our nation’s youth, but also represents a clarion call for bold action at every level of government to implement proven strategies to keep kids off tobacco.
FDA approves Surfaxin to prevent breathing disorder in premature infants
The U.S. Food and Drug Administration today approved Surfaxin (lucinactant) for the prevention of respiratory distress syndrome (RDS), a breathing disorder that affects premature infants.
FDA issues warning letter to makers of AeroShot “caffeine inhaler”
The U.S. Food and Drug Administration today issued a warning letter to Breathable Foods Inc., makers of AeroShot, for false or misleading statements in the labeling of their product, and told the company that the Agency has questions about the safety of the “caffeine inhaler.” The FDA also expressed concern about the use of AeroShot by children and adolescents and in combination with alcohol.
Price Chopper Supermarkets Recalls Streusel Topped Fruit Pies
Price Chopper Supermarkets is issuing a voluntary recall on its Price Chopper Bakery five and eight inch Apple, Blueberry, Cherry, and Peach Streusel Pies due to the streusel topping containing eggs, an allergen that was not listed on the ingredient label. Other than this labeling issue, the product is safe for consumption for those not allergic to eggs.