FDAnews Device Daily Bulletin


Dec. 21, 2005

Women who undergo postmastectomy breast implantation frequently experience short-term local complications, according to a new study that found 31 percent of women who underwent an initial implantation developed at least one adverse event.

Surgical or medical intervention is commonly required during the reconstructive course, but reconstruction failure is rare, concluded the study published in the journal Archives of Surgery.

The study, which measured complications incidence rates, collected data on short-term local complications among 574 Danish women who underwent postmastectomy reconstruction with breast implants from 1999 to 2003.

According to the study, 49 percent of the adverse events occurred with three months after implantation and 67 percent within six months. Surgical intervention was required after initial implantation among 21 percent of women, most frequently because of capsular, asymmetry or displacement of the implant, the study said. In addition, 36 percent of women who underwent subsequent implantation experienced at least one adverse event, and 21 percent underwent surgical intervention to treat complications or optimize cosmetic results.

When weighing benefits and risks associated with reconstruction, "the patient should consider that breast reconstruction is a process involving planned and unplanned supplementary surgical correction to achieve the desired result, the study concluded.

One women's health advocate said the statistics in the study "are very worrisome, given that these women had breast implants for anywhere from seven weeks to four years, with an average of only 23 months."

A slightly longer-term study of implant manufacturer Inamed's silicone implants, presented by FDA scientists in 2003, found that 46 percent of reconstruction patients needed additional surgery within the first two to three years, said Diana Zuckerman, president of the National Research Center for Women & Families. Previous research has shown that new complications occur every year, with complications requiring additional surgery tending to increase over time, she added.

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