Article

Silicone Breast Implant Injector: A Retooled Breast Augmentation Device

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Abstract

Silicone breast implants are used worldwide for breast augmentation. After an axillary, periareolar or inframmary incision has been made to create an adequately sized pocket; the surgeon usually uses his or her fingers to insert the implant. The use of fingers makes the insertion process time-consuming, a few minutes or more. There are some complications, including need to ensure that the incision is long enough for the implant to be inserted, scar hypertrophy caused by implant insertion friction damage to the edge of incision, and the occasional need to ask the surgical assistant to lend more fingers to facilitate satisfactory insertion and placement. In addition, the use of gloved fingers to repeatedly push on the implant can increase the risk of contamination, postoperative silicone microleakage, and capsular contracture. To resolve these problems, we developed an improved silicone breast implant injector (reusable stainless steel 2007; single use polypropylene 2018) that can be used more easily than fingers and other "no touch" devices. From 2013 to 2017, the first author, a plastic surgeon at our clinic, used the 2007 reusable stainless steel injector to perform breast augmentations in 53 patients (Ave. age 23.8 years; range 19-67 years), 5 (8.8%) receiving 250-ml implants, 41 (77.4%) 251-300-ml implants, and 7 (13.8%) 301-400-ml implants. Overall, results were satisfactory except for two patients (3.7%) in whom capsular contracture occurred. There were no ruptures. Use of the injector made it possible to shorten the length of the incisions from the traditional 4-7 to 3-4 cm and expedited insertion time from a few minutes to a few seconds. This "no touch" insertion technique reduced implant damage caused by finger pushing, leading to a decrease in silicone microleakage and capsular contracture rate. It was performed with no friction trauma to the incision edge or harm to the surgeon's fingers. It was found to be an effective alternative operative tool for the insertion of silicone breast implants.Level of evidence IV This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

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... Polysiloxane materials with alternating Si−O bonds in the main chain possess many excellent properties, such as highand low-temperature resistance, good flexibility, and biocompatibility. 1 Thus, they are widely used in biomedical materials, 2 such as vascular pumps, 3−5 breast prostheses, 6,7 heart valves, 8 and artificial skin. 9,10 With regard to medical materials, different individuals have different size requirements. ...
... 7 A re-sterilizable breast implant injector has been devised. 8 Even a technique as simple as the use of the paper cover from the implant box can facilitate a minimal-touch technique with very low rates of capsular contracture. 9 Although in vivo evidence of reduced biofilm-producing species on implant surfaces from the use of funnels is lacking, the case for utilizing funnels was demonstrated in a cadaver model. ...
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Overt infection and biofilm formation resulting from breast augmentation are rare but serious problems that can lead to contracture and a need for revision surgery. The Keller Funnel is a medical device composed of a rip-stop nylon sleeve with a hydrophilic inner coating. One claim of the funnel is that it facilitates a "no touch" technique, thereby limiting contamination. To date, there are no data to support this claim. The authors evaluate skin and breast parenchyma contamination with standard implantation techniques and the Keller funnel. Insertion techniques were tested in two fresh cadavers. Smooth, round, moderate-plus silicone gel implants were placed for each experiment. To quantify the amount of skin contamination, a 2% w/v fluorescein paste was painted onto the cadaver thorax. After implantation, the implants were soaked in 250 mL of sterile water, and the fluorescence emission of the resulting solution was measured with an ultraviolet-visible spectrophotometer. To qualify the potential contamination from breast parenchyma, the cadaver breast tissue was swabbed with methicillin-sensitive Staphylococcus aureus, and the implant surfaces were cultured postimplantation. The funnel resulted in a 27-fold decrease in skin contact for all smooth gel implants (P = .00059). The amount of skin contact and potential contamination increased incrementally with increasing implant volume when either the funnel or digital implantation techniques were used. Bacterial contamination from breast parenchyma was two times more likely with the standard digital insertion technique (P = .06). The Keller funnel appears to significantly reduce the amount of skin contact and potential parenchyma contamination.
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Capsular contracture remains a common and preventable complication of implanted breast prostheses. As our understanding of the pathophysiology continues to develop, it is prudent to reexamine existing beliefs in a contemporary context. This article presents a current summary of clinical and laboratory evidence, expressed as an interaction between potentiating and suppressing factors, and how this understanding can be applied to practice.
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In order to reexamine the possible association between bacterial presence and capsular contracture, 55 silicone devices (mammary implants or tissue expanders) were cultured at the time of their removal from 40 patients. Special culture techniques were used in an attempt to recover bacteria adhering to the smooth-surfaced implant and encased in glycocalyx biofilm. Bacteria were detected on 56% (15 of 27) of implants surrounded by contracted capsules and on 18% (5 of 28) of those without capsular contracture (p less than 0.05). Only three implants tested positive using routine plating techniques. The predominant isolate was Staphylococcus epidermidis. The concept that capsular contracture is associated with subclinical infection of silicone implants is supported by this study. With changes in the microbiological technique, bacterial recovery and growth occurs at a frequency greater than previously thought.
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Infection is the leading cause of morbidity that occurs after breast implantation and complicates 2.0-2.5% of interventions in most case series. Two-thirds of infections develop within the acute post-operative period, whereas some infections may develop years or even decades after surgery. Infection rates are higher after breast reconstruction and subsequent implantation than after breast augmentation. Risk factors for infection associated with breast implantation have not been carefully assessed in prospective studies with long-term follow-up. Surgical technique and the patient's underlying condition are the most important determinants. In particular, breast reconstruction after mastectomy and radiotherapy for cancer is associated with a higher risk for infection. The origin of infection in women with implants remains difficult to determine, but potential sources include a contaminated implant, contaminated saline, the surgery itself or the surgical environment, the patient's skin or mammary ducts, or, as suggested by many reports, seeding of the implant from remote infection sites. Late infection usually results from secondary bacteraemia or an invasive procedure at a location other than breasts. Diagnostic and management strategies are proposed and the value of peri-operative surgical prophylaxis is revisited. The current hypothesis of the possible role of low-grade or subclinical infection in the origin of capsular contracture is also reviewed.
does implant insertion with a funnel decrease capsular contracture? Prelim Rep
  • N A Flugstad
  • J N Pozner
  • R A Baxter
  • NA Flugstad
Breast implant capsules and subclinical infection
  • Lbm Snell