December 16, 2016
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Aeroform tissue expander for breast reconstruction provides convenient, expedient results

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The Aeroform tissue expander had similar overall adverse event rates compared with saline expanders, but was more convenient and reached complete expansion sooner, according to study results published in Plastic and Reconstructive Surgery.

The prospective study included 150 women undergoing tissue expansion following mastectomy between October 2011 and December 2014. Ninety-eight patients received the Aeroform expander and 52 received saline expanders, with 71% of the patients undergoing bilateral reconstruction.

The success rate per breast was 149 of 155 (96.1%) for the Aeroform and 82 of 83 (98.8%) for the saline expanders. Aeroform device malfunctions included loss of communication (n = 9), deflation (n = 25) and overinflation (n = 2). Improvements to the device saw a significant decrease in malfunctions, with nine instances of deflation and one instance of overinflation, compared with 25 instances of deflation and four instances of overinflation with the original device.

The Aeroform’s median times to complete expansion and to complete reconstruction were 21 days (95% CI, 15-24) and 108.5 days (95% CI, 99-117) (P < .0001), respectively. The saline expanders’ median times to complete expansion and to complete reconstruction were 46 days (95% CI, 38-55) and 136.5 days (95% CI, 119-147) (P < .0001), respectively.

The overall rates of adverse events were 63.6% for the Aeroform and 63.5% for the saline expanders. Rates of adverse events related to the devices were 19.2% for Aeroform and 21.2% for saline.

Patients reported an average score of 2 on a 10-point pain scale at both the start of expansion and at 1 week follow-up, with no difference in the intensity of pain for either group.

A majority of patients and physicians found the Aeorform expanders easy to use (98% and 90%, respectively) and convenient (93% and 88%, respectively). Patient overall satisfaction results were 78% for the initial Aeroform product and 84% for the improved model. Physician satisfaction improved from 68% to 83%. – by Talitha Bennett

Disclosure: Ascherman reports he is a consultant for AirXpanders. Please see the full study for the other researchers’ relevant financial disclosures.