Practical Method for the Removal of Silicone Breast Implants

Summary:

Silicone breast implants are widely used in both cosmetic and reconstructive breast operations worldwide. Although there are numerous devices designed to assist with the placement of implants, there are limited tools available for their removal. The challenge is amplified when complications such as implant rupture occur, increasing the risk of silicone contamination in surrounding tissues. Historically, improvised solutions—such as repurposed syringes and saline bottles on suction tubing—have been used to assist with implant explantation. However, these makeshift tools were often too small to accommodate the full volume of the implant. Furthermore, recent updates to Australian hospital sterilization standards have imposed additional restrictions on the autoclaving of such improvised devices, underscoring the need for a cost-effective, compliant alternative. Despite new commercially available devices becoming available on the market, they may be inaccessible due to budget limitations, low stock, or unavailability in certain countries. This article describes a customizable extraction technique using a readily available, low-cost, autoclavable device for the sterile removal of ruptured silicone implants. The device features a large diameter opening, which allows for the easy extraction of both ruptured and intact implants. With a collection capacity of up to 1 L, it meets the necessary volume requirements for most procedures. Additionally, it can be assembled in under 3 minutes using standard equipment found in operating rooms and adheres to updated sterilization protocols.

Takeaways

Question: With new sterilization requirements in Australia, is there a simple, efficient, and cost-effective device for the removal of ruptured silicone breast implants when patented devices are not available?

Findings: We offer an alternative extraction technique utilizing a readily available, low-cost, and autoclavable device for the sterile removal of ruptured implants when patented devices are not available.

Meaning: This cost-effective, simple technique provides an effective and sterile means of removing silicone from the breast pocket, aligning with contemporary surgical standards.

INTRODUCTION

Breast augmentation is one of the most commonly performed cosmetic surgical procedures worldwide, whereas postmastectomy implant-based reconstruction remains a popular technique to restore breast shape.^1,2 As the number of these procedures rises worldwide, so do potential complications. These complications range from postoperative infections, malposition, and breast animation deformity to more severe issues such as capsular contracture and implant rupture.

Implant Rupture

Implant rupture, caused by trauma, degradation, or surgical mishaps, presents a significant challenge for both the surgeon and the patient.² Breast implants have a finite life span, and most commonly, over the patient’s lifetime, they will require replacement or removal.³ Ruptures can be intra- or extracapsular, posing risks of silicone leakage into surrounding or distant tissues.³ Rupture rates are documented at between 9% and 12.2%.^4,5 The sticky nature of silicone makes the removal process time-consuming and messy, with additional contamination of the patient, surgeon, and surgical instruments.^2,6 New devices on the market have made the removal of ruptured implants more streamlined and effective.^2,3

Current Challenges in Explantation

Despite the equipment available for implant insertion, there is a notable lack of tools specifically designed for implant removal. Although systems such as the De Novo Bateman Bottle and Gronovich’s extraction PolyBix device exist for removing ruptured or intact implants, these are often unavailable globally, limited by hospital funding and stock issues.^2,7 As a result of the limitations of these patented devices, surgeons improvise with tools such as Toomey syringes or repurposed saline bottles connected to suction tubing to create their own extraction system.⁸ However, these makeshift solutions are often inadequate for the task; for example, the Toomey syringe holds only 60 mL, insufficient for the volumes involved in explantation.⁸

Further complicating matters, recent revisions to sterilization standards in Australia have restricted the use of autoclaved single-use items, such as saline or water bottles, in the operating theater.¹ These constraints underscore the need for a new, cost-effective, and readily available solution.

TECHNIQUE

This article presents a technique that utilizes a large-volume, customizable extraction device designed for the sterile removal of ruptured implants. The technique uses an autoclavable male urinal collection bottle with a wide-diameter opening that facilitates the easy extraction of both ruptured and intact implants. With a capacity of up to 1 L, it meets any necessary volume requirements. It can be assembled in under 3 minutes using regulation-approved autoclavable equipment readily available in most operating theaters, ensuring that it can be accessed even during unexpected situations.

Device Assembly

• Components required: sterile suction tubing, a bag spike, and an autoclavable male urine collection bottle. (See figure, Supplemental Digital Content 1, which displays the ruptured silicone breast implant extraction device fully assembled. The suction tubing is connected to the thinnest part of the bottle via a sterile bag spike. Wall suction is adjusted to achieve the appropriate level of suction at the mouth of the bottle, http://links.lww.com/PRSGO/D966.)

• A sterile bag spike is used to create a small hole in the end of the bottle.

Suction tubing is connected to the bottle via the bag spike, and the wall suction is adjusted for appropriate suction strength at the bottle’s mouth. (See Video 1 [online], which displays the setup of the device with the insertion of the bag spike at the end of the bottle and attachment of the suction tubing.)

Video 1. displays the setup of the device with the insertion of the bag spike at the end of the bottle and attachment of the suction tubing.

Download video file ^{(1.1MB, mp4)}

Surgical Procedure

A standard skin incision is made at the inframammary fold of the breast to gain access to the implant pocket. After blunt dissection down to the capsule, an incision is made in the implant capsule. Upon incision, the device (now with suction) is placed over the opening. The suction helps in the quick and easy removal of the implant and any contents (eg, leaked silicone). (See Video 2 [online], which displays the device used to extract an intact silicone breast implant.) (See Video 3 [online], which displays the device used to extract a ruptured breast implant and the surrounding silicone contaminant.) The device’s large capacity means it can be used to remove multiple implants (both sides), eliminating the need for recreating the setup.

Video 2. displays the device used to extract an intact silicone breast implant.

Download video file ^{(1MB, mp4)}

Video 3. displays the device used to extract a ruptured breast implant and the surrounding silicone contaminant.

Download video file ^{(3.4MB, mp4)}

DISCUSSION

Complications arising from silicone breast implants are varied. Explantation of these devices, regardless of the reason for removal, presents significant surgical considerations due to not only risks to the patients but also mental health impacts of device removal. Quick and effective removal of these devices has been difficult due to a lack of appropriate equipment. Only recently have devices become available that can assist with extraction; however, limitations in budget and stock levels can impede the use of these premade commercial devices. Additionally, in Australia, new sterilization regulations, particularly the introduction of Australian Standard 5369:2023 in December 2023, have forced surgeons to adapt their approaches to implant removal. The new standard sets out uniform requirements for the cleaning, disinfection, and sterilization of reusable medical devices and other related devices to ensure they are safe for use and pose no risk of infection. These guidelines are critical to maintaining safety across Australia’s healthcare system.

Under these updated regulations, items such as single-use plastic saline bottles, which were previously used to create implant removal devices, are no longer permitted.¹ These bottles, “not intended to be used as a medical device,” fall outside the scope of acceptable medical equipment under the new standards. Consequently, surgeons need to find alternative methods that comply with these stringent guidelines.

To meet these requirements, we propose a simple technique involving using a sterile suction system, which includes an autoclavable male urine collection bottle, to efficiently remove implants and any remnant silicone from the breast pocket. This system not only meets the contemporary sterilization standards but also provides an effective, large-volume, adjustable solution. It is a cost-effective alternative to patented devices that can be used safely within the operating theater. Although commercial variations of this system exist (eg, the Bateman Bottle and PolyBix device), this simple technique overcomes the restrictions imposed by the new Australian Standard 5369:2023¹ when these patented systems are not available.

This technique is highly adaptable, as it can be implemented using a wide variety of male urine collection bottles available worldwide. The specific bottle model used in this method is made of polypropylene and is designed to be autoclaved or steam sterilized. Comparable models with these features are widely available in many countries, ensuring the system’s broad applicability.

By ensuring adherence to these updated sterilization regulations, this method represents a modern, safe, and practical approach to implant removal, protecting both patient health and surgical integrity.

DISCLOSURE

The authors have no financial interest to declare in relation to the content of this article.

ETHICS APPROVAL

The device met all Australian Standards for Sterilization as set out in the Department of Human and Health Services Act AS/NZS 4187:2014.