Microbiologic Safety of the Transareolar Approach in Breast Augmentation

Jianu, Dragoş Cătălin; Săndulescu, Oana; Streinu‐Cercel, Anca; Berciu, Ioana; Blidaru, Alexandru; Filipescu, Maria; Vartic, Mihaela; Cobani, Oltjon; Jianu, Ștefan; Tălăpan, Daniela; Dorobăţ, O; Stăniceanu, Florica; Streinu‐Cercel, Adrian

doi:10.1093/asj/sjv106

Cited by 18 publications

(9 citation statements)

References 17 publications

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“…We thank Dr Bartsich for providing valuable input on our previously reported work 1 and we agree with her conclusion: the breast cannot be considered a sterile site. 2 As the human body includes 10 times more bacterial cells than human cells, 3 it is virtually impossible for any particular bodily compartment which communicates with the exterior to be sterile.…”

supporting

confidence: 78%

Response to “Commentary on: Microbiologic Safety of the Transareolar Approach in Breast Augmentation”

et al. 2016

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supporting

confidence: 78%

Response to “Commentary on: Microbiologic Safety of the Transareolar Approach in Breast Augmentation”

et al. 2016

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“…A 2016 microbiological study of cultures obtained from breast skin and parenchyma at surgery found that the cultured organisms are not distinct from ordinary skin flora, and that the periareolar approach is microbiologically safe. 31 A specific microbiome or organism has not been linked to capsular contracture. Bacterial profiles are patient-specific rather than disease-specific.…”

Section: Discussionmentioning

confidence: 99%

Incision and Capsular Contracture Risk

Swanson¹

2023

Ann Plast Surg

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Background Breast implants can be introduced through a variety of incisions, most commonly an inframammary incision, but also a periareolar incision or an axillary incision. Usually, the implant is inserted through the same incision used in performing an augmentation/mastopexy. Some authors use a separate inframammary incision. Capsular contracture is the most common complication of breast augmentation. One theory holds that it is caused by an infected biofilm, prompting surgeons to minimize implant handling, known as the “no touch” technique. This review was undertaken to investigate the relationship, if any, between the access incision and the risk of capsular contracture. Methods An electronic literature search was conducted to identify publications comparing capsular contracture rates by the access incision. Results Ten studies were evaluated. Most were retrospective series. Three were prospective core studies. Some studies reported an increased risk of capsular contracture for a periareolar incision; a similar number did not. One study supported a separate inframammary incision at the time of vertical augmentation/mastopexy. Discussion Bacterial studies in the last decade show that the resident bacteria on the skin surface and within breast tissue are similar. Sophisticated microbiological evaluation of breast capsules reveals that the microbiome relates to the patient, as opposed to a specific bacterial profile for capsular contracture. A review of the statistics used in determining an advantage for a separate incision at the time of vertical augmentation/mastopexy reveals that there is no statistically significant risk reduction when using an additional inframammary incision, which adds an unnecessary scar. Conclusions The access incision at the time of breast augmentation or augmentation/mastopexy is unlikely to affect the capsular contracture risk. There is no need to make a separate incision to insert the implant at the time of augmentation/mastopexy, or to isolate the implant from contact with breast parenchyma. Little evidence supports the “no touch” technique. The etiology of capsular contracture remains unknown.

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“…Under ordinary sterile surgical technique, there is no opportunity for contamination other than by resident microorganisms on the skin and in the breast. A 2016 microbiological study found that the skin bacteria and breast parenchymal microorganisms are similar 38 . A sophisticated microbiological study published in 2019 failed to identify a specific bacterium that is linked to capsular contracture 39 .…”

Section: Discussionmentioning

confidence: 99%

The Keller Funnel, Capsular Contracture, and Conflict of Interest

Swanson

2023

Ann Plast Surg

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Background The Keller funnel (Allergan; AbbVie Inc, North Chicago, IL) is commonly used to insert breast implants as part of a “no touch” protocol. Many plastic surgeons believe that this device reduces the risk of capsular contracture. This review was undertaken to evaluate the evidence regarding any reduction in capsular contracture rate, other possible benefits, safety and to investigate financial conflict of interest. Methods A PubMed electronic literature search was conducted to identify studies comparing capsular contracture rates with and without the Keller funnel. The Open Payments database was accessed for information regarding corporate payments to plastic surgeons. Results Two retrospective historical case-control studies, published in 2016 and 2018, were identified. Both studies had important confounders, including implant type and placement, which are known to affect capsular contracture rates. Major financial conflicts of interest were present. Most authors did not disclose these conflicts, which totaled more than $1 million and were usually categorized as gifts from Allergan, which purchased the Keller funnel in 2017. Discussion Financial conflict of interest, along with publication bias, creates a bias toward publication of positive findings. No reliable evidence supports a “no touch” technique, which is a misnomer because manual handling of implants is unavoidable, even when using a funnel. Recent microbiological studies do not support a specific bacterial etiology for capsular contracture. No evidence supports contamination by the surgeon touching the implant. Among other proposed benefits, such as reduced operating time, less contamination, a shorter incision, and less implant trauma, only a slightly shorter incision (1 cm) is supported by the evidence. The cost is $150 per funnel. Conclusions No reliable evidence supports the use of a Keller funnel to reduce the risk of capsular contracture. Both supportive studies contain confounding variables, limited follow-up time, and no plausible scientific basis for efficacy. Institutional review board approval of studies on human subjects is not optional. Financial conflicts of interest are extraordinary in their magnitude and potential for creating undue influence. Greater transparency and honest disclosures are needed.

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Microbiologic Safety of the Transareolar Approach in Breast Augmentation

Cited by 18 publications

References 17 publications

Response to “Commentary on: Microbiologic Safety of the Transareolar Approach in Breast Augmentation”

Response to “Commentary on: Microbiologic Safety of the Transareolar Approach in Breast Augmentation”

Incision and Capsular Contracture Risk

The Keller Funnel, Capsular Contracture, and Conflict of Interest

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