Reply: Late Seromas in Natrelle 410 Form-Stable Silicone Breast Implants
Our study was not designed or intended to address the question of comparative incidence of late seroma with textured versus smooth implants. Although we acknowledge that the reports cited by Drs. Chung and Hall-Findlay suggest that the risk of late seroma may be higher with textured implants compared with smooth implants, firm conclusions are difficult to draw based on the available evidence. For example, a recent level II evidence study examining the safety of breast implants (n = 3506 implants, with approximately equal proportions of smooth and textured) found that seroma occurred in 1.2 to 2.4 percent of patients at up to 9 years of follow-up; however, no distinction was drawn for early versus late seroma, and comparative analysis of seroma with smooth versus textured implants was not described.3
I would also like to address the skepticism of Drs. Chung and Hall-Findlay regarding our conclusions concerning rates of late seroma with Natrelle 410 implants on the basis of the study’s industry sponsorship. Studies of this magnitude, which are critically important to advance our knowledge of breast surgery, involving thousands of patients (n = 17,656 patients with 31,985 implants), could not have been performed without either industry support or major private charitable or governmental assistance. The stringent, independent peer review of our findings provided by Plastic and Reconstructive Surgery lends assurance to the validity and integrity of our research. We firmly stand by our findings and conclusions as unbiased and objective. All disclosures were made available during the review process.
Drs. Chung and Hall-Findlay also question the statistical analyses performed in our study. As stated in the article, the small number of late seroma cases [n = 31 of 31,985 implants (0.1 percent)] precluded more sophisticated risk factor analyses.
Although we respect Dr. Hall-Findlay’s experience with various implants in her practice, our published study with level II evidence provides significant insight into the risk of late seroma with textured implants. Additional prospective studies that include all manufacturers and all surface types will further our knowledge on the incidence, potential risks, and causes of late seroma.