Before Deciding on Breast Implants, Consider FDA Precautions

WEDNESDAY Feb. 27, 2013 -- If you're thinking about getting breast implants, there are some things you need to know before you make your decision, according to the U.S. Food and Drug Administration.

In the United States, two types of breast implants are approved for sale: saline-filled implants (those filled with a saltwater solution) and silicone gel-filled implants. Both have a silicone outer shell and vary in size, shell thickness and shape. The implants are used for increasing breast size, for reconstruction after breast cancer surgery or injury, and to correct developmental defects.

Women need to understand that breast implants are not lifetime devices. The longer a woman has breast implants, the greater the chances that she will develop complications, some of which will require surgery, according to the FDA.

"The life of these devices varies according to the individual," Gretchen Burns, a nurse consultant at the FDA's Center for Devices and Radiological Health, said in an FDA news release. "All women with implants will face additional surgeries -- no one can tell them when."

A few women have kept their original implants for 20 to 30 years, but "that is not the common experience," Burns said.

Women considering breast implants need to thoroughly research each type of implant to learn about their characteristics, the agency said. This information can be found in the Summary of Safety and Effectiveness Data label section for each implant. These summaries provide information about the use, risks, warnings, precautions and studies associated with FDA approval of each implant.

Ask your surgeon for the most recent version of the labeling of a breast implant. You should have at least one to two weeks to review the information before making a decision, the FDA said. In some cases, however, surgery may need to be performed sooner.

Ask surgeons about their experience with implants, the surgery and the way the implants might affect your life. Be sure to tell your surgeon about previous surgeries and your body's response -- for example, whether surgery resulted in excessive scar tissue -- and outline your expectations.

Learn about the long-term risks of breast implants. For example, women with breast implants may have a slightly increased risk of anaplastic large cell lymphoma, a rare type of non-Hodgkin lymphoma, the FDA said.

Women with silicone implants should get MRI screenings to detect ruptures three years after receiving the implants and every two years after that.

Burns said women with breast implants need to continue to perform breast self-examinations and to get mammograms to screen for early signs of cancer.

"Just because you have implants doesn't mean you can ignore other breast health recommendations," she said.

More information

The U.S. Food and Drug Administration outlines the risks of breast implants.

Posted: February 2013


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