Local complications are common after postmastectomy reconstructive breast implantation, with an adverse event rate of 31% in one large prospective study, reported Dr. Trine F. Henriksen of the Danish Registry for Plastic Surgery of the Breast, Copenhagen, and associates.
In what they described as “the first prospective epidemiological study to provide quantitative data on short-term local complications among women receiving implants for breast reconstruction,” the investigators found that unplanned surgical or medical intervention is often required during the course of reconstruction. Some 20% of women needed surgical procedures to treat complications within the first 2 years of mastectomy, a rate that is nearly four times higher than that with cosmetic implantation.
“When evaluating benefits and risks associated with breast reconstruction, the surgeon and patient should consider that the reconstructive process often requires additional surgical intervention to treat local complications or to achieve the desired cosmetic result. Detailed information on the likelihood of local complications … should be an essential part of adequate informed consent” for mastectomy patients seeking breast implantation, Dr. Henriksen and associates said (Arch. Surg. 2005;140:1152–9).
They studied the issue using data from the Danish Registry for Plastic Surgery of the Breast, which provided the world's “first systematic collection of preoperative, perioperative, and postoperative data in relation to mammoplasty procedures.”
The study included all 574 women who underwent 901 postmastectomy breast implantations in Denmark between June 1999 and July 2003.
There were 484 initial implant procedures and 417 reimplant procedures—implant exchanges or implant reinsertion after a prior removal. Just over half (51%) of these secondary procedures were unplanned; the remaining 49% were planned second-stage operations after tissue expansion. The mean patient age at initial implantation was 50 years, and the subjects were followed for a mean of 23 months after initial implantation and 24 months after subsequent implantation.
Unplanned repeat procedures were performed for a range of reasons, and patients often had more than one indication. Capsular contraction was the most common cause for repeat procedures (23%), followed by unacceptable asymmetry (20%), displacement of the implant (16%), and suspicion of implant rupture (5%).
After initial implantation, 31% of women experienced at least one adverse event, ranging from delayed wound healing to severe capsular contraction. Sixteen percent developed two adverse events, and 8% developed at least three. Wound infection was the most common immediate adverse event, affecting 7% of women. Skin perforation, seroma, periprosthetic infection, and hematoma each affected 3% of the women.
After a repeat implantation procedure, 36% of the women developed one adverse event, 19% developed two, and 8% developed three or more adverse events. Asymmetry and displacement of the implant were the most frequently reported problems, affecting 19% of women. Hematoma, capsular contraction, prolonged pain, wrinkles, and scar indentation each affected 3% of the women.
A total of 21% of the women required surgical intervention after initial implantation and another 3% required other treatments.
Approximately half of the complications occurred within the first 3 months after implantation, 67% within the first 6 months, and 91% within the first year.