On July 8, 2002, an FDA advisory committee heard evidence from breast implant manufacturers that studies had shown that as many as 25% of women who had saline breast implants had undergone secondary surgery within five years of operation. Breast implants are currently made by two manufacturers, Mentor and McGhan.

Mentor, which was criticized for its small study population, said 20% of women seeking breast augmentation sought a second operation, mainly because a hard capsule had formed around the implant. Women also requested new implants because they wanted to change sizes, or because of leaks and deflation, said Mentor. McGhan said 25% of its augmentation group had a second operation.

Capsular contracture (firmness) and leakage have long been recognized as common problems following breast augmentation, however, the data presented is surprising to us in light of our previous study carried out in 2000.

In tracking patients over an eight year period, 19% of patients had reported some firmness but only 8% found it severe enough to require surgery – a 1% annual risk. Deflation had occurred in 4% of patients. It was rare in our experience to have patients undergo further surgery for size change. We attribute this to the care we take in instructing patients in preoperative sizing to attempt to insure that they obtain the result they desire.

FDAWhile the data presented to the FDA raises concern, we still feel confidence in our own data. While we plan to continue to evaluate our results, we have seen nothing to suggest any difference in our experience. Why the data obtained by the manufacturers is so different is puzzling.

While the rate of reoperation is of concern, fortunately, nothing was reported that would indicate any health danger related to the implants. Furthermore, it is important to understand that often reoperation requires a fairly simple procedure. Replacement of leaking implants is probably the easiest procedure to undergo. The operation requires less than an hour and most patients return to normal full activity the following day. Risk is very low with the very slight chance of infection (less than 1/2%) being the greatest concern. Furthermore, the warantee provided by the manufacturer offsets most of the cost during the first few years following surgery.

We feel it likely that our lower rate of reoperation for firmness is attributable to our use of the endoscopic surgical technique in a high percentage of patients. Minimal bleeding with very precise dissection couples with submuscular placement are factors that may very well limit the risk of sever encapsulation.

While we feel that it is important that prospective patients be made aware of FDA data, we still feel a high degree of confidence in our own experience and will continue to update our data.