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A Third Breast Implant Option

?A new silicone-gel breast implant received conditional approval Friday from the U.S. Food and Drug Administration to be used for breast augmentation in women 22 and older and for breast tissue reconstruction at any age. This latest approval makes the newest implant by Sientra of Santa Barbara, California just the third breast implant device approved for use in the United States, joining implants currently made by Allergan and Mentor.

Although silicone breast implants have been problematic for years and many critics have said the devices can rupture and leak, and cause a variety of health problems, including cancer and lupus, the deputy director for science in the FDA's Center for Devices and Radiological Health, Dr. William Maisel said “Data on these and other approved silicone-gel filled breast implants continue to demonstrate a reasonable assurance of safety and effectiveness." So far, the new implant tests have been successful and there have been few of the most common implant complications including tightening of the area around the implant, implant removal, uneven breast appearance and infection.

The FDA approved Sientra's newest implant based on three years of data from clinical studies of over 1,800 implant patients, and additional long-term studies will include a seven-year follow-up of the current participants; as well as a 10-year-long study of 5,000 implant patients to monitor them for long-term complications, including rheumatoid arthritis, breast and lung cancers. The research will also include five more individual studies highlighting the association of the new implant and diseases like brain cancer, cervical cancer and lymphoma.

Reactions to the approval were generally optimistic as the Sientra brand implants have already been used in Brazil for several years and if there were any concerns about them causing cancers, the FDA would have not approved them. Physicians also noted that the advantage of silicon gel over saline implants is that the silicon provides a more natural look and feel, while saline implants can wrinkle and show through the skin. Silicone gel implants had been completely banned in the United States until 2006 when the FDA approved those made by Allergan and Mentor for breast reconstructive surgery and for breast enlargement in women 22 and older. With the introduction of a third implant choice, women undergoing breast cancer reconstruction or cosmetic breast augmentation in the United States today now have another option.

When the ban on silicone implants was lifted in 2006 the FDA ruled they were safe and could remain on the market. However, the agency also emphasized that silicone implants don't last forever, and half of all women with such implants would need them removed within 10 years of the initial surgery. Data from the FDA shows that one in five women who received silicone implants needed to have them removed due to complications and half of the women who received implants for reconstruction needed them removed in the same time period. The most common serious complications cited were hardening of the area around the implant; the need for additional surgeries; implant rupture, wrinkling, breast asymmetry, scarring, pain and infection.

The FDA estimates there are nearly 10 million women worldwide that have had breast implant surgery and the agency recommends that these women should consult their doctors regularly and notify their health-care providers when they notice any unusual symptoms such as pain, asymmetry or swelling. Any woman considering breast implants today should remember that breast implants are not lifetime devices and long-term monitoring is critical to ensure good health and prevent complications.

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