Is Iatrogenic Implant Contamination Preventable Using a 16-Step No-Touch Protocol?

Dylan Singh, BS; Ruixue Zhang, BS; Kaitlin H Hori, BS; Fereydoun D Parsa, MD, FACS


ePlasty. 2022;22(e38) 

In This Article

Abstract and Introduction


Background: Intraoperative contamination of the surgical field during aesthetic breast augmentation may lead to implant infection with devastating consequences. This study covers a period of 30 years and is divided into 2 phases: a retrospective phase from 1992–2004 when a standard approach was used and a prospective phase from 2004–2022 when a no-touch approach was implemented to avoid contamination.

Methods: Patients in the standard and no-touch groups underwent aesthetic breast augmentation by the same senior surgeon (FDP) in the same outpatient surgical facility during the 30-year period of the study. Patients are divided into 2 groups: from 1992–2004 and from the implementation of the no-touch protocol in 2004–2022.

Results: Patients who underwent breast augmentation using the no-touch approach developed no infections, whereas the standard group had an infection rate of 3.54% (P = .017). The validity of this finding is discussed.

Conclusions: The no-touch approach as described in this article was effective in reducing implant infection rate when performing aesthetic breast augmentation by 1 surgeon at 1 surgical center during an 18-year observation period. Multicenter prospective cooperative studies are necessary to validate perioperative iatrogenic contamination as the cause of implant infection and to explore optimal approaches that could eliminate implant contamination.


Surgery has been influenced during the past decade by progress made in the aviation industry, both of which involve teams of specialists working together in potentially life-threatening situations where even the most minor errors can lead to devastating consequences.[1] Both of these fields have strived to improve globally accepted and understood safety measures to decrease morbidity and mortality.[2] In healthcare, this influence has led to the development of intraoperative surgical safety checklists, among many other measures, to ensure optimal outcomes. However, like in aviation, complications are inevitable, and surgical complications including infections continue to burden patient care.[3] Specifically in plastic surgery, breast augmentation is one of the most commonly performed cosmetic surgical procedures in the United States.[4] Surgical site infections (SSI) can lead to poor patient outcomes, reconstruction failure, and even mortality.[5] The SSI rate following implant-based breast reconstructions has been reported as approximately 2 to 29%.[6,7] Contamination of the implant during surgery, skin or mammary duct flora, and the surgical environment can all contribute to infections.[8] Minimizing or eliminating these contaminating sources is critical in lowering the likelihood of implant contamination and infection.

Implant sterilization, breast pocket irrigation, and antibiotic prophylaxis are a few infection prevention measures currently being utilized during breast augmentation procedures.[9–12] These approaches are taken to reduce the incidence of implant infection and capsular contracture.[13] However, the efficacy of these measures has not been scientifically established due to the lack of evidence-based data.[5] In a recent survey among the American Society of Plastic Surgeons (ASPS), members suggested the need for best practice guidelines in areas such as breast pocket irrigation and implant soaking agents.[14] The US Food and Drug Administration (FDA) banned the use of the soaking solution povidone-iodine in 2000 due to its potential degradative effect on silicone elastomer shells.[9] They suggested using antimicrobial solutions containing antibacterial agents such as bacitracin, cefazolin, and gentamicin for infection prevention instead.[10] However, with little evidence of the benefits of breast pocket irrigation and implant immersion with antibiotics,[10,11] the FDA revoked the ban against povidone-iodine use in 2017. Several studies showed that the povidone-iodine solution was effective in reducing capsular contracture due to its strong bactericidal activity against many strains of resistant organisms, including Methicillin-resistant Staphylococcus aureus, Vancomycin-resistant Enterococcus, and Mycobacterium.[15,16]

Besides minimizing contamination sources, incision sites also play a role in reducing infections, and several studies have reported that periareolar incisions lead to a higher rate of implant infection compared with inframammary crease incisions, likely due to colonization of breast ducts and parenchyma by bacteria.[17–19] In addition, air circulation in operating room, contamination by other surgical team members, and improper glove changing practices may increase infection risk.[20]

The general concept of a no-touch ideology for infection prevention in surgery was first introduced by Sir William Arbuthnot Lane in 1894.[21] One of the essential rules in this no-touch approach was that "a gloved finger should never come in contact with the wound." In 1942, HAT Fairbank, the consulting surgeon of the Hospital for Sick Children in London, England, provided a detailed description of Arbuthnot's no-touch principles and laid the foundation of modern surgical aseptic measures.[21,22] Nevertheless, Fairbank's recommendations are rarely followed in current practices, and as an example the same gloved fingers used during the operation routinely come into contact with the implants and the breast.

Several unexplained cases of implant infections during the early stages of this study prompted further reflection on Arbuthnot Lane's original no-touch ideology. This inspired the implementation of the second phase of this study (2004 to present), which made certain additions to ensure contamination risk was further reduced (Figure 1 and Figure 2). This report aims to determine whether an evidence-based no-touch approach may effectively reduce implant infections compared with the standard approach used from 1992–2004 that resulted in an infection rate of 3.45%.

Figure 1.

The 16-step no-touch protocol.

Figure 2.

No-touch glove donning: a) scrub nurse unveiling sterile gloves; b) gloves are lifted while cuff is folded; c) glove is lifted by proximal end, assuring no contamination to any part of the glove that will come in contact with the implants; d) glove is placed on surgeon's hand.