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    Study examines connection between highly textured breast implants, double capsules

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    Aggressively textured breast implants are associated with double capsules and late seromas, according to a retrospective study of several hundred primary bilateral breast augmentations and primary bilateral mastopexy augmentations.

    The study, which was performed and published recently by Canadian plastic surgeon Elizabeth J. Hall-Findlay, M.D., is a look back at her own patients treated at Banff Plastic Surgery, in Banff, Alberta, over almost two decades.

    "I have always followed my results in all of my breast surgery patients, because I think it is important to review outcomes. I have been performing careful measurements to be able to add some 'science' to the 'art' of plastic surgery," Dr. Hall-Findlay says.

    Dr. Hall-Findlay says she had not seen significant numbers of late seromas or double capsules in the early years of her practice, which she started in 1983. She began to notice them in 2006.

    "Given that it is difficult to assess capsular contracture when comparing different surgeons' outcomes, I decided to compare my own outcomes to each other. I tried not to change any of the other variables such as prep solution, pocket irrigation and so on, and I noticed that late seromas and double capsules were a new finding that I had not seen in the first 25 years of my practice. The study was my way of figuring out what was happening," she says.

    Dr. Hall-Findlay says she noticed double-capsule formations on some Biocell (Allergan) textured-surface implants when revisions were being performed for various reasons, such as size change and capsular contracture. She did not really take notice, however, until a patient with Style 410 implants presented with an expanding seroma 19 months after her original surgery.

    Dr. Hall-Findlay says she recalls that the left breast of this patient kept enlarging, and it was assumed that the problem might have been some form of infection, but detailed questioning and eventual cultures ruled that out. When the patient was taken into surgery, there was a large amount of serosanguineous fluid and a double capsule, Dr. Hall-Findlay reports, adding that this is just one example of several that eventually prompted her study.


    This image illustrates how a complete double capsule formed around an aggressively textured (Biocell) implant, and shows that the double capsule did not form where the implant is smooth. (Photos credit: Elizabeth J. Hall-Findlay, M.D., F.R.C.S.C.)
    STUDY METHODS Dr. Hall-Findlay reviewed all of the primary bilateral breast augmentations and primary bilateral mastopexy augmentations performed in her practice after 1992. There were 209 patients with saline implants; 160 patients with CML and CMH (CUI) MicroCell textured-surface implants; 105 patients with Biocell textured-surface silicone gel breast implants; and 152 patients with smooth round (Allergan and Mentor) silicone gel breast implants. She reviewed these cases for complications and revisions to see whether any patterns emerged and found that 14 patients developed double capsules, and that these double capsules were only seen with the Biocell textured-surface implants.

    Three patients developed late seromas — more than a year after their original surgery — with two patients requiring urgent drainage of an expanding seroma/hematoma. Seven patients were found to have double capsules as an incidental finding for procedures, such as asymmetry and bottoming out, and five patients were found to have double capsules when surgery was performed for capsular contracture.


    The double capsule is cut open, and this view reveals how the double capsule has contracted over the implant and has caused it to fold as the capsule tightened.
    The review of complications and revisions showed that the silicone gel implants performed better than saline implants; highly cohesive MicroCell textured CMH and CML implants had by far the best capsular contracture profile; and Biocell texturing had an increased capsular-contracture rate. Capsular contractures were evaluated using the Baker classification; no patient had a Baker IV capsule in this series.

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