Reply: Late Seromas in Natrelle 410 Form-Stable Silicone Breast Implants

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I am grateful for the opportunity to respond to the letter from Drs. Chung and Hall-Findlay regarding the recent article by my colleagues and me.1 Drs. Chung and Hall-Findlay reference findings in the published literature that suggest a heightened risk for late seroma with textured implants compared with smooth implants, thus questioning the interpretation of our results. In our article, we cite a consensus statement and literature review2 that reports the incidence of late seroma at 0.13 percent among patients who received both smooth and textured implants and supports the conclusion that the rate of late seroma observed in our analysis (0.1 percent) is consistent with reports for breast implants in general. Their letter highlights the paucity of high-level evidence in breast surgery literature, as the studies that they cite are all level of evidence IV and V based on analyses from single centers and/or comparatively small numbers of patients. None involved formal statistical analysis but were primarily descriptive in nature. By contrast, our study provided level II evidence and was based on analysis of thousands of patients. The reference we cite in the Discussion2 to support comparisons of the general risk of late seroma with the risk in our study is also not level I or II evidence, again strengthening the need for higher quality studies on this important topic.
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.

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