Breast Implants And The Fda

Breast implants were first sold in the 1960s in the United States

, when there was hardly any regulation of medical devices by the government. In 1976, the Medical Device Amendment gave the Food and Drug Administration (FDA) authority to regulate medical devices. This required the FDA to obtain reasonable assurance of safety and effectiveness before these devices were marketed. Since then, the FDA has monitored the performance and safety of breast implants and their use in breast enhancement procedures.

By 1990, around a million women had breast implants, even though there were no published empirical studies about their safety, and the FDA had never approved them. Therefore, the FDA requested scientific data from the medical industry in order to assess the benefits and risks of breast implants. In 1992, a moratorium was placed on silicone breast implants due to inadequate information about the safety and effectiveness of breast implants. Pending further review, the regulatory body sanctioned restricted access to the devices for patients who needed breast reconstruction and revision surgery, but not for cosmetic use.

After extensive research, silicone gel-filled implants were approved for breast enhancement in the year 2006. In a recent update Dr. Jeffrey Shuren, director of the FDAs Center for Devices and Radiological Health assured women that the agency continues to support the safety and effectiveness of silicone gelfilled implants when used as intended.

Silicone implants are now available for women of all ages for reconstruction purposes, and in women aged 22 and older for breast enhancement. Saline breast implants are also FDA approved for women aged 18 and older. The FDA sets the minimum age limit for women who wish to undergo breast enhancement for cosmetic purposes to ensure that a woman is emotionally mature enough to fully understand the risks of the procedure. The age restrictions are different for the two types of breast implants, because the risks for saline implants differ from those of silicone-gel implants.

Along with the age restriction for breast enhancement, the FDA's other guidelines for women undergoing the surgery aim to increase the safety and efficacy of the procedure. For instance, the FDA lists breast implant complications on their website, for women to consider before undergoing augmentation. The agency's recommendations also include routine MRI scans for women with silicone breast implants for implant rupture screening.

Research on breast implants continues on an ongoing basis and there are several clinical studies on both the types of implants. Additionally, the FDA is committed to ensure that post-approval studies by implant manufacturers, on women who have had breast enhancement surgery, are completed. Dr. Shuren has stated that the agency would continue to monitor and collect safety and performance information on silicone gel-filled breast implants.

Women who wish to augment their breast size should consider the FDA's information on implant complications before deciding to undergo breast enhancement surgery. It is also best for women in the long-run to follow the FDA's medical recommendations for their safety and optimal breast health.

Disclaimer: This article is for general awareness and should not be considered as medical advice. Consult a qualified plastic surgeon for exact guidance.

by: Anna Susan

POST COMMENT

Boutique & Luxury Hotels In Bath Are Unsurpassed In Terms Of Luxury And Service Strategic Planning And Costing Of Developing An App Rose Cut Diamond Beads And Findin Jewelry By Ojjewelry Gold And Diamond Bangles By Ojjewelry Modern Gemstone And Diamond Rings Jewelry Choices In Isagenix Products Including The Isagenix 9 Day Cleanse And Isagenix Diet Babies Are Born To Explore The World Online And Offline!! Using Isagenix Products For The Best Detox Cleanse And Other Methods For A Body Cleanse Opt For Innovative Supermarket Stand Design And Exhibition Design Stand Industrial Products And Services From Topnotch Companies For Different Needs Relax And Unwind At The Serene Beaches Of Koh Samet In Thailand Best Five Wi-fi Routers To Make Your Home Networking Quick And Reliable Getting To Know About Isolation And Loneliness