Saline breast implants remain popular - and on the market Breast enlargement is getting bigger - in popularity. The number of women choosing breast augmentation increased more than 25 percent in 1999, according to statistics from the American Society of Plastic Surgeons (ASPS). Board-certified ASPS plastic surgeons performed more than 167,000 breast augmentation surgeries in 1999 compared with about 132,000 the previous year.
Results of two studies also point to the popularity of this procedure. A recent study from the University of Minnesota showed that 93 percent of women with saline-filled breast implants are happy with their implants. Many of the 450 women surveyed expressed increased satisfaction with their appearance and greater self-confidence after their surgery. Furthermore, another study, by the ASPS, showed that 84 percent of women who have their breast implants removed choose to replace them with new implants.
Now the most commonly used type of breast implant, saline-filled implants, have won a vote of confidence from the federal Food and Drug Administration (FDA). After years of studying the safety of breast implants, the FDA gave full approval in 2000 to saline-filled breast implants made by two companies. The ruling allows Mentor Corporation and McGhan Medical Corporation to continue to market their saline implants for use in breast augmentation and breast reconstruction. It also provides for improved patient information from the manufacturers regarding the benefits and risks of these devices.
"This is very good news for women who have or want breast implants," says Bruce Cunningham, MD, professor and chair of plastic surgery at the University of Minnesota, Minneapolis. "The FDA, after a thorough examination, has confirmed what several scientific panels concluded. Saline-filled breast implants do not appear to cause significant systemic health risks."
Saline implants do pose some minor local risks, including a chance of rupturing and needing replacement within the first decade. A recent study at Dr. Cunningham's institution found that each saline-filled implant has an average deflation rate of less than 6 percent at 10 years. If a saline implant leaks, the body harmlessly absorbs the sterile salt water.
It is estimated that the rupture rate for implants is about 5% over the first 5-10 years; the exact lifetime of the implants is not known.
"I tell every patient of mine that this is not a lifetime device. She may need a repeat operation," says V. Leroy Young, MD, a professor of plastic surgery at Washington University School of Medicine in St. Louis.
Another potential risk is tightening of the scar tissue around the breast implant, called capsular contracture. This can cause breast firmness and occasional discomfort. The risk of capsular contracture ranges from 2 to 20 percent, depending on where the implant is placed. Plastic surgeons have found a decreased chance of this complication by placing the implant under the chest wall muscle, rather than directly behind the breast tissue.
Even when there are minor complications, most patients who have breast augmentation report that they would make the same choice again. "Studies have shown that there are very high levels of satisfaction among women with saline-filled breast implants," says Dr. Young.
The continued availability of saline-filled breast implants should be welcome news to many women. Of the breast augmentation procedures performed by ASPS surgeons, 97 percent involve saline implants.
In 1992, the FDA restricted the use of another type of breast implant, filled with silicone gel, because of possible health concerns. The agency determined that only women undergoing breast reconstruction or participating in approved clinical studies may get gel-filled implants. Since that decision, numerous scientific studies have concluded that there is little or no evidence that breast implants cause any systemic illness.