5 Things to Know About Breast Implants: Breast Implants are Not All The Same. They Need to be Researched Before Use

2. Research products.

Review the patient labeling. FDA advises that women look at the Summary of Safety and Effectiveness Data (SSED) for each implant to learn about their characteristics and the fillers used. These documents describe the risks associated with that breast implant, and how likely they are to occur for each implant based on the available evidence from clinical studies.

SSEDs have been produced for all approved saline and silicone gel-filled breast implants.

These summaries provide information on the indications for use, risks, warnings, precautions, and studies associated with FDA approval of the device.

Look at the frequency of serious complications found in the SSED.

The most serious are “those that lead to further surgeries, such as ruptures or capsular contracture,” says Tajanay Ki, a biomedical engineer in CDRH.

FDA advises health care providers to give women the full labeling—all of the patient information from the manufacturer—for an implant.

Ask your surgeon for the most recent version of the labeling.

You should have at least 1-2 weeks to review the information before making a decision, but with some reconstruction or revision surgery cases, it may be advisable to perform surgery sooner. 

This is part of a series of posts about breast implants, beginning here.
For more information please visit
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm338144.htm