More surgery for half of all breast implant cases. (Five-Year Follow-up of Saline Implants).

GAITHERSBURG, MD. -- One-fourth to almost one-half of all patients who have had saline breast implants will need another breast operation within the next 5 years, according to studies presented at a meeting of the Food and Drug Administration's General and Plastic Surgery Devices Panel.

The most common reason for subsequent surgeries was that patients wanted to change the size or shape of their breasts. Other reasons for subsequent surgeries included capsular contracture, leakage or rupture, scar revision, and removal without replacement.

The studies were presented by two manufacturers of the devices at the meeting.

The companies, Mentor Corp. and Inamed Corp., were required to conduct 10-year safety studies as conditions of implant approval, granted in 2000. The meeting was held to update the FDA on their progress.

The data also included results of focus group studies about the companies' informational patient brochures.

Many focus group members said the data tables showing relative risk were unclear, so the brochures were revised and are awaiting FDA approval.

Both companies used the Kaplan-Meier analysis for their safety data, which have been collected for 5 years.