Breast Implants And The Fda

By Author: Anna Susan
Total Articles: 11
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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 FDA’s Center for Devices and Radiological Health assured women that the agency “continues to support the safety and effectiveness of silicone gel–filled 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.

AUTHOR BIO:

Anna Susan is a senior professional, researching on Breast Aesthetics, and working for a top implant manufacturing company. Learn about Breast Enhancement, Breast Implants and locate a qualified plastic surgeon in your city. Visit MentorConfidence.com