Breast Augmentation Safety in Outpatient Surgery Facilities

GURNEE, Ill. -- The American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF) released today a preliminary analysis of data collected on 246,552 breast implant procedures performed in AAAASF-accredited facilities.

These procedures were either for reconstructive or aesthetic purposes and yielded an extremely low incidence of unanticipated sequelae. An unanticipated sequela was reported in only one in 143 procedures performed or less than 1 percent (.70 percent) of the time.

It is important to note that AAAASF requires all physicians operating in AAAASF-accredited facilities to report all unanticipated sequelae every six months as part of the organization’s mandatory Quality Assessment/Quality Improvement Program. AAAASF has been a staunch proponent for data collection in the outpatient surgery facility having required physicians to report random cases for review and unanticipated sequelae for the last five years.

In May 2004, a paper published in the journal Plastic and Reconstructive Surgery titled “Analysis of Outpatient Surgery Center Safety Using an Internet-Based Quality Improvement and Peer Review Program” documented the safety of surgery performed in outpatient surgery facilities accredited by the AAAAFS. Geoffrey R. Keyes, MD, and colleagues Robert Singer, MD, Ronald E. Iverson, MD, Michael McGuire, MD, James Yates, M.D, Alan Gold, MD, and Dennis Thompson, MD. Keyes, et. Al. analyzed data collected on 411,617 surgical procedures performed from the years 2001 through 2002 in more than 900 outpatient surgery facilities, revealing an unanticipated sequelae incidence of 0.33 percent. In a preliminary review of data collected in the aforementioned program from the years 2001 through 2004, the authors directed attention to safety in the performance of breast implantation surgery.

Analysis was performed upon 913,154 surgical procedures entered by surgeons participating in the program. Breast implantation, either for reconstructive or aesthetic purposes, was performed in 27 percent of the studied cases, yielding 246,552 breast implant procedures analyzed.

Unanticipated sequelae were divided into two categories: early- and late-occurring events. The early-occurring events were those unanticipated sequelae that might occur with any operative procedure such as bleeding, infection, cardiovascular irregularities associated with anesthesia and other categories of sequelae. These early events occurred within one month of the date of the operative procedure. Late events included capsular contracture, deflation of implants, loss of implants through extrusion, and miscellaneous events.

Significant sequelae, those related to a physiologic response to surgery as opposed to patient cancellation, mild postoperative nausea or light-headedness after surgery, were reviewed. There was a total of 1,730 significant sequelae. This represents an incidence of 1 in 143 procedures performed, or .70 percent. The most common early sequela, as previously reported in the study of 2004, was hematoma formation. There were 1,059 patients who had hematomas or one in 233 procedures performed. There were no deaths associated with hematoma formation. Other early sequelae included infection, wound breakdown, pneumothorax. There were 142 patients hospitalized for management of early sequelae. Two patients died, one from a pulmonary embolism, five days after surgery, the other from an asthmatic attack 12 hours after surgery.

The most common late occurring event was deflation of an implant. This occurred in 173 patients or one in 1,425 procedures. Other late sequelae included capsular contracture, which was reported in 141 procedures or 1 in 1749 of the breast implant procedures performed. (Note: It is important to realize that these late-occurring events were not required to be entered into the quality assurance program. Most of the late sequelae occurred beyond the one-month post-operative period. Furthermore, many of the late sequelae are related to procedures that may have been performed before the 2001-2004 dates of study.) This preliminary review indicates the statistical safety of breast augmentation when compared to other outpatient surgical procedures. A more in-depth analysis is underway.

Source: AAAASF

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