Researchers at Memorial Sloan-Kettering Cancer Center couldn't identify any patient- or treatment-related predictors for breast implant failure. What the study did determine was that almost one-third of the women experienced a complication requiring permanent removal (13.3%) of the implant or removal and replacement (17.1%).
The study provides outcomes data on 751 middle-aged women who all followed the same schedule regimen of treatment. The results contribute to a growing body of literature that is helping women determine if they should have breast reconstruction, and if so, what type and when.
The two-stage tissue expander/permanent implant approach represents a significant percentage of breast reconstruction surgeries performed in the U.S. At Memorial Sloan-Kettering, 35% of patients diagnosed with stage II or III breast cancer who had a mastectomy of one or both breasts elected to have breast reconstruction. A total of 151, or 58%, underwent their postsurgical treatment at the cancer center between May 1996 and August 2006.
The treatment protocol consisted of immediate placement of a tissue expander during the mastectomy procedure. Tissue expansion began seven to 14 days following surgery and continued for five to seven months. Chemotherapy was administered five weeks after surgery over a period of five months.
Approximately one month after chemotherapy, the tissue expander was replaced with a permanent implant. Radiation therapy began eight weeks after the end of chemotherapy.
All but 5% of the patient cohort received anthracycline- and taxane-based chemotherapy. Radiation therapy for all 151 patients consisted of a radiation dose of 50 Gy administered in 25 to 28 fractions.
The patients were followed for at least 11 months and up to almost 14 years, with a median follow-up of seven years, according to lead author Dr. Alice Ho, a radiation oncologist specializing in the treatment of breast cancer, and colleagues. At the time of their treatment, the patients ranged in age from 26 to 74; the majority were in their 40s. Sixty-nine percent had stage III breast cancer, and 60% had lymphovascular invasion. The seven-year distant disease-free survival rate was 81%, and the seven-year overall survival rate was 93%.
Half of the patients experienced complications within the first 24 months after completing radiotherapy, Ho and colleagues reported. For almost half of the women (47%), the original implants were removed due to what the researchers defined as multifocal etiologies: suboptimal cosmesis, dissatisfaction, and/or grade 3 or 4 capsular contraction. The second most common cause was infection.
The majority (62%) of women who had another breast reconstruction procedure opted to receive another implant. The remainder chose autologous reconstruction.