A Rebuttal of Antibiotic Irrigation as a Method to Reduce Risk of Capsular Contracture and Breast Implant-Associated Anaplastic Large-Cell Lymphoma

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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.

Section: Discussionmentioning

confidence: 99%

“…The biofilm theory for capsular contracture has been challenged 40,41 . The capsular contracture rate has remained steady over the last 2 decades despite efforts to reduce bacterial contamination 41 . One of these measures, Betadine irrigation, involves pouring a nonsterile cytotoxic solution into a breast wound 41,42 .…”

Section: Discussionmentioning

confidence: 99%

The Keller Funnel, Capsular Contracture, and Conflict of Interest

Swanson

2023

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“…The nontumor samples from patients with capsular contracture but without BIA-ALCL actually contained more bacteria than the BIA-ALCL samples. A comparison of bacterial counts, comparing the breast capsule affected by BIA-ALCL to the normal breast capsule in 3 women, was much too small to be significant 18 …”

mentioning

confidence: 89%

Concerns Regarding Dishonesty in Reporting a Large Study of Patients Treated With Allergan Biocell Breast Implants

Swanson

2022

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I n 2017, Adams et al 1 published a study reporting no cases of breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) among 8 plastic surgeons implanting a total of 42,035 Allergan (now AbbVie Corp, Lake Bluff, IL) Biocell implants. This open-access publication quickly became one of the most viewed studies in the plastic surgery literature. It was featured as a cover article and was the subject of a journal club discussion and podcast. This article is ranked at the 98th percentile among all articles of a similar age. It has received 5372 full text views to date and has been cited in 129 publications. 2 In February 2019, Dr Jason Hammer, executive medical director of Abbvie, testified before the French health regulatory agency that biofilm was the leading theory for the development of BIA-ALCL, and this complication could be prevented by following the 14-point plan. 3 He cited the 2017 "international multicenter study" of 42,000 Biocell implants "followed for over 11 years."The following month, at the 2019 Hearing of the Food and Drug Administration (FDA), the same publication 1 was cited to support the continued use of macrotextured implants. 4 Adams, the lead author, testified that adoption of the 14 points could eliminate the risk of BIA-ALCL. Another plastic surgeon, and spokesperson for Allergan, also referenced this 2017 study 1 in her testimony and claimed a zero rate of BIA-ALCL when the 14 steps are followed. A handout distributed at the meeting and still available at the FDA Web site includes this claim and reference. 5 Six of the 8 authors of the 2017 study 1 disclosed that they were Allergan consultants, 1 including Adams, who denied financial conflicts at the FDA hearing, 4 despite a publication disclosing his conflicts with Allergan and Sientra. 6

“…7 The scientific basis for the 14-point plan has been challenged. [8][9][10] This review was undertaken to explore the scientific basis for the incision location as a factor related to the incidence of capsular contracture.…”

mentioning

confidence: 99%

Incision and Capsular Contracture Risk

Swanson¹

2023

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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.