FDA approves new silicone gel-filled breast implant

Approval conditioned on post-approval safety studies

    On 9th March 2012, 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.

Silicone gel-filled breast implants are medical devices implanted under the breast tissue or under the chest muscle for breast augmentation or reconstruction. These implants have a silicone outer shell that is filled with silicone gel. They come in different sizes and have either smooth or textured shells.

Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery.

Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery.

With today’s approval, there are now three FDA-approved silicone gel-filled breast implants in the U.S. manufactured by Allergan, Mentor and Sientra.

“Data on these and other approved silicone gel-filled breast implants continue to demonstrate a reasonable assurance of safety and effectiveness,” said William Maisel, M.D., M.P.H., deputy director for science in the FDA’s Center for Devices and Radiological Health.

“It’s important to remember that breast implants are not lifetime devices. Women should fully understand risks associated with breast implants before considering augmentation or reconstruction surgery, and recognize that long-term monitoring is essential.” said Maisel.

The FDA based its Sientra approval on three years of clinical data from 1,788 participants. Complications and outcomes reflected those found in previous studies of other breast implants and included tightening of the area around the implant (capsular contracture), re-operation, implant removal, an uneven appearance (asymmetry), and infection.

In June 2011, the FDA released a report that included preliminary safety data from post-approval studies from earlier breast implant approvals. The experience collecting and analyzing data from these studies informed the design and structure of post-approval studies for Sientra breast implants.

In addition to other post-approval conditions, Sientra will:

• continue to follow the 1,788 clinical trial participants in their pre-market study for an additional 7 years;
• conduct a 10-year study of 4,782 women receiving Sientra silicone gel-filled breast implants to collect information on long-term local complications such as capsular contracture, as well as less common disease outcomes, such as rheumatoid arthritis and breast and lung cancer; and
• conduct five case-control studies that will evaluate the association between Sientra’s silicone gel-filled breast implants and five rare diseases: rare connective tissue disease, neurological disease, brain cancer, cervical/vulvar cancer, and lymphoma.

“The design of these post-approval studies will require Sientra to collect valuable safety information with adequate enrollment and follow-up,” said Maisel. “The FDA is committed to working with breast implant manufacturers to collect useful post-market data on long-term safety and effectiveness.”

Sientra Inc. is based in Santa Barbara, Calif.

Source:http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm295429.htm

Indian Academy of Pediatrics Immunization Schedule

     Immunization has become an essential component of primary health in India since long time.There is Universal Immunization program which has been adopted to Indian situation and with slight modifications National immunization program has been implemented by the Govt of India. But Indian Academy of Pediatrics recommends few extra vaccines and protocols for immunization.The IAP Immunization schedule as follows….

  

Source: http://www.iapindia.org/immunisation/immunisation-schedule

Weight loss prevents urinary incontinence in obese women with type 2 Diabetes

       The Look AHEAD (Action for Health in Diabetes) trial recently came out with conclusion that moderate weight loss in obese/overweight type 2 diabetic women. The study determined the effect of weight loss on the prevalence, incidence and resolution of weekly or more frequent urinary incontinence in overweight/obese women with type 2 diabetes after 1 year of intervention.

     The urinary incontinence is one of the prominent problems in obese women with DM Type 2 though incontinence doesn’t depend on the weight. Women in this substudy (2,739, mean ± SD age 57.9 ± 6.8 years, body mass index 36.5 ± 6.1 kg/m²) were randomized into an intensive lifestyle weight loss intervention or a diabetes support and education control condition.

      Moderate weight loss reduced the incidence but did not improve the resolution rates of urinary incontinence at 1 year among overweight/obese women with type 2 diabetes. Weight loss interventions should be considered for the prevention of urinary incontinence in overweight/obese women with diabetes.

Source:http://www.sciencedirect.com/science/article/pii/S0022534711054620

FDA approves two new pancreatic enzyme products to aid food digestion

          Two new pancreatic enzyme products used to help aid food digestion, Ultresa (pancrelipase) and Viokace (pancrelipase), were approved today by the U.S. Food and Drug Administration.

         Ultresa is a delayed-release capsule used to treat children and adults with cystic fibrosis, a serious genetic disorder affecting the lungs and other organs, or other conditions who cannot digest food normally because their pancreas does not make enough pancreatic enzymes.

        Viokace, in combination with a proton pump inhibitor, is used to treat adults who cannot digest food normally. Adults with chronic pancreatitis, a continuing, chronic inflammatory process of the pancreas, or those who have had some or all of their pancreases removed (pancreatectomy) may not digest food normally because they lack needed enzymes or because their enzymes are not released into the bowel (intestine). Viokace’s safety and efficacy in children has not been established.

         “The approvals of Ultresa and Viokace, along with the other approved pancreatic enzyme products, allow health care providers to prescribe the product that is most appropriate for the estimated 200,000 patients in the United States who have pancreatic insufficiency,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research.

     Ultresa and Viokace are the fourth and fifth pancreatic enzyme products approved by FDA. Other FDA-approved pancreatic enzyme products include Creon (2009), Zenpep (2009) and Pancreaze (2010). Approved pancreatic enzyme products meet FDA standards for safety, efficacy and product quality.

     Unapproved pancreatic enzyme products had been available for many years. FDA established a date of April 28, 2010 for the makers of pancreatic enzyme products to stop manufacturing and distributing unapproved products.

   Ultresa and Viokace are marketed by Bridgewater, N.J.-based Aptalis Pharma U.S. Inc.

Source:http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm294143.htm

FDA approves first quadrivalent vaccine to prevent seasonal influenza

      USA FDA has approved FluMist Quadrivalent vaccine to prevent seasonal influenza in people of age group of 2yrs to 49 yrs.It contains  strains of Influenza A and 2 strains of Influenza B.

      “Illness caused by Influenza B virus affects children, particularly young and school-aged, more than any other population,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “A vaccine containing the four virus strains most likely to spread and cause illness during the influenza season offers an additional option to aid in influenza prevention efforts.”

        Vaccination is the best method to prevent influenza. Influenza seasons are unpredictable and can be severe, even deadly. Between 1976 and 2007, estimates of seasonal influenza-associated deaths in the United States ranged from a low of about 3,000 to a high of about 49,000 people.

       The safety and effectiveness of FluMist Quadrivalent is supported by studies conducted previously for the FluMist trivalent formulation and three new clinical studies conducted in the United States involving about 4,000 children and adults. The studies demonstrated that the immune responses were similar between FluMist Quadrivalent and FluMist.

           Adverse reactions reported were similar among those receiving FluMist Quadrivalent and FluMist. The most commonly reported adverse reactions were runny or stuffy nose in both children and adults, and headache and sore throat in adults.

         FluMist Quadrivalent is manufactured by MedImmune LLC of Gaithersburg, Md.

      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

Source:http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm294057.htm