A Medical Device Daily

Breast implant manufacturer Mentor (Santa Barbara, California) has released results of a new national online survey of breast augmentation patients and women considering the surgery, saying that it offers "new insights about who is choosing breast implants and why they are choosing them."

The timing of the survey release appears – well, rather timely: The General and Plastics Surgery Devices Advisory Panel of the FDA is scheduled to consider the premarket approval (PMA) application by Mentor for its silicone gel-filled breast implants on April 13, the final day of a three-day session by the panel.

Mentor said that the survey showed almost 90% of the respondents agreed with the statement that "breast augmentation is a personal choice that helps women to achieve the confidence and well-being to flourish in other areas of their lives." Further, the company said that women who have had breast augmentation "are overwhelmingly satisfied with their choice."

Eight of 10 respondents said they were "satisfied" with the surgery, and almost half (48%) indicated they were "very satisfied." Three-quarters of them said that if they had to do it over again, they would, and 70% would recommend the procedure to a friend or family member.

Mentor said that "the majority" of respondents disagreed with the "notion" that breast augmentation is primarily for rich women or exotic dancers/models trying to advance their careers.

Mentor CEO Joshua Levine said that the results "confirm what we have known for years: breast augmentation patients are intelligent, thoughtful women completely capable of making informed decisions. In addition, these findings continue to challenge the myths that breast implant patients are young, uneducated and easily influenced."

Penn, Shoen, and Berland Associates conducted the survey of 1,200 women, which included 200 breast augmentation patients and 1,000 women who stated they were "very likely" or "somewhat likely" to undergo breast augmentation surgery. Women choosing to complete this survey were predominately suburban mothers, with 65% of the women being over age 35 and married.

Supporting Mentor's application for the PMA is its pivotal Core Gel Study, which followed 1,007 women who were implanted with silicone gel-filled breast implants for either augmentation, reconstruction or revision surgery. The data submitted to the FDA includes information from the three-year follow-up period, as well as longer-term clinical data specific, the company said, "to the integrity of Mentor's silicone gel-filled breast implants."