Silicone Breast Implants

Among the many choices that need to be made when planning a Breast Augmentation, choosing between a saline-filled breast implant or a silicone-filled implant is one of the more difficult decisions. Both types of implant have specific advantages and any number of these factors may influence which option could be more beneficial for you:

  1. Your existing breast anatomy
  2. The look and feel you desire
  3. The placement of the implant above or below the chest muscle
  4. The size of the implant
  5. The incision used to insert the implant under your breast

The information given below is intended to give you an overview of your silicone implant options, thereby allowing you to make a more informed decision. To further assist you in the decision making process, during your Breast Augmentation consultation with Dr. Jugenburg, you will look at and feel various pre-filled implant samples, and try on a range of sizers. At the Toronto Cosmetic Surgery Institute we offer all sizes and shapes of breast implants so that every woman can rest assured that we will be able to create just the look and feel she desires.

Silicone implants are more ideal in women who are very thin and have very little skin/fat to hide the implant.  Silicone is a little softer and has less rippling than a saline implant, and these differences are seen in a thinner patient, which is why Dr. Jugenburg may recommend a silicone implant over a saline implant.

For information on saline breast implants, please refer here.

What Are Silicone Breast Implants?

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A silicone breast implant consists of a highly durable, elastic silicone shell prefilled with a viscous medical grade (see below) silicone gel that has a pliable consistency closely matching that of natural breast tissue. Silicone implants are available in a wide range of sizes and profiles, and with different shape and surface texture options, to suit the individual requirements and goals of each woman.

 

  1.  Base width (or diameter) – width on the chest wall; women with narrower chest walls require smaller diameter implants for a proportionate appearance.
  2. Size (or projection) – protrusion from the chest wall; a suitable size for any given women will depend on her existing breast anatomy and body proportions.
  3. Shape: Round or Shaped (Teardrop or Anatomic) – Round implants can give a natural or fake looking appearance depending on their placement. Teardrop implants are designed to mimic the gentle contours of a natural breast (for Breast Reconstruction patients only).
  4. Shell surface: Smooth or Textured – a textured surface for greater tissue adherence, while the smooth surface is less prone to rippling/wrinkling.

Further information on your breast implant choices is given here.

Allergan Inspira Silicone breast implants

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Medical Grade Silicone

Antiperspirants, skin lotions, hair care products (shampoos, conditioners and styling products), and many other non-cosmetic items, including baby bottle nipples (teats), contain some form of silicone. Two different types of silicone are commonly available: medical grade silicone and industrial grade silicone. While industrial grade silicone is found in sealants, lubricants and adhesives, the manufacturing process for medical grade silicone is altered to avoid production of a toxic substance (hydrogen chloride gas) found in industrial silicone. All of the silicone implants available at the Toronto Cosmetic Surgery Institute for Breast Augmentation contain medical grade silicone, have passed through rigorous Health Canada approval processes, and are pure.

The benefits of medical grade silicone:

  1. Manufactured in a clean environment using special non-toxic techniques to ensure that it is free from any unwanted substances and compatible with the human body.
  2. Tested to be safe (it does not cause unwanted reactions, illnesses or cancer).
  3. Found on medical devices, such as needles, catheters, medical tubing, anesthesia equipment and many others.
  4. Found on pacemakers, artificial joints and many other devices that are implanted into the body.
  5. Also used in many non-medical fields.

Recognized Safety of Silicone Breast Implants

Silicone breast implants have been successfully used in Breast Augmentation by millions of women for more than 50 years. When first introduced, the popularity of silicone implants continually rose due to their superior, natural feel compared to saline implants. Despite this, silicone implants also attracted a lot of controversy. Although no clinical studies have ever discovered any reliable connection between silicone implants and various illnesses, in 1992 the FDA and Health Canada restricted the use of silicone implants to women having Breast Reconstruction after breast cancer surgery (Mastectomy). Pending further studies, Breast Augmentation procedures were therefore limited to saline implants only. However, in Europe and Asia, the use of silicone implants for cosmetic purposes has never been restricted.

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Mentor and Allergan, the two breast implant manufacturers available in Canada, maintain highest standards of quality in their manufacturing processes. Both manufacturers are also supported by years of extensive clinical research and a comprehensive body of data that supports the safety and reliability of their breast implant products.

In 2006, the FDA reviewed the research data compiled by Allergan and Mentor and once again approved the use of silicone implants for breast enlargements; Health Canada followed suit soon after. Both manufacturers continue to undertake extensive clinical studies as a commitment to ensuring that every patient has the best possible outcome with her breast implants.

Minimal Implant Leakage

The amount of silicone released through the intact shell of current generation breast implants is minimal and associated with no risk for patients. Implant leakage was determined (by the manufacturer Mentor) to be:

  1. Less than 1/1000th the weight of a pin.
  2. More than a million fold below established safety limits (based on the results of FDA reviewed studies).
  3. More than a hundred-fold below the amount of silicone absorbed from daily exposure to common consumer products containing silicone, such as antiperspirants, skin lotions and hair care products.

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Unlikely Implant Rupture

A breast implant rupture refers to a process where the outer shell of the implant tears. When a silicone breast implant ruptures, it is much harder to detect than a saline implant rupture because the appearance of the breast often remains unchanged, a process known as a silent rupture.

Current generation silicone implants contain a cohesive, gelatin-like silicone gel that is much thicker than saline and is formulated to remain safely and uniformly intact. If any cohesive silicone were to be released, it would leak into the implant capsule only (the scar tissue that surrounds the implant). In such a case, if left untreated, the breast may become firmer and misshapen, hard lumps may appear, and changes in sensation (such as tenderness, pain, numbness, tingling or burning) may develop.

If a patient believes that one of her implants may have ruptured, she should arrange to see Dr. Jugenburg immediately. Ruptures can be caused by a number of different factors, such as physical trauma, general wear and tear, Capsular Contracture (implant hardening), or complications from medical procedures. Silent ruptures are normally determined by using ultrasound or MRI scans to screen the breasts. Although routine tests also are recommended every few years; modern breast implants are highly durable and a damaged or ruptured implant is rare. In the highly unlikely event that an implant rupture has occurred, an Implant Exchange procedure will need to be performed to remove and, if appropriate, replace the ruptured implant.

FDA Approval

Before approving the use of silicone breast implants manufactured by Allergan and Mentor, the FDA reviewed an extensive body of clinical data, as well as a wealth of other information, to determine the benefits and risks of silicone implants. As conditions of approval, the FDA also required each manufacturer to conduct post-approval studies to characterize the long-term performance and safety of their implants.

An FDA report on silicone breast implants emphasized that there is no evidence to suggest that silicone gel-filled breast implants cause breast cancer, connective tissue disease or any other illness, and that silicone implants are safe to use. It also indicates that breast implant surgery may not be a one time event, but that sometime during their lifetime 20% of patients will require another procedure. However, there are many reasons as to why additional surgery may be required, such as a patient requesting a size change. Furthermore, for Breast Reconstruction (after breast cancer surgery), additional procedures are commonly performed as part of the reconstruction process.

The key FDA findings on silicone breast implants (manufactured by Mentor) at 10 years after first surgery are:

  1. There is a 10% risk of implant rupture in Breast Augmentation patients, and a 14% risk in Breast Reconstruction patients.
  2. Implants are removed (with or without replacement) in 7% of Breast Augmentation patients and 23% of Breast Reconstruction patients (of which more than half are due to a patient requesting a size change).
  3. Reoperation is needed in 20% of Breast Augmentation patients and 38% of Breast Reconstruction patients (including patients requesting a size change and the need for a biopsy).

Key complications after Breast Augmentations:

  1. Capsular Contracture (implant hardening) – 11% (in our patients 1 – 5%)
  2. Additional surgery (for any reason) – 20%
  3. Implant removal (with or without replacement) – 7%

Cohesive Gel Breast Implants

Cohesive Gel (silicone) breast implants are the current generation of silicone breast implants. Each implant is filled with a thick, cohesive formulation of silicone that has a consistency more resembling that of a pliable solid than a liquid. As a result of this increased density, Cohesive Gel implants have a firmer feel than older liquid silicone implants, but are less prone to rippling/wrinkling and the silicone will hold together uniformly in the unlikely event of an implant rupture (i.e., the silicone will not leak out).

The manufacturer Allergan has a new Inspira® line of Cohesive Gel implants, while the manufacturer Mentor offers MemoryGel® Cohesive implants, both of which are available with different consistencies. Mentor MemoryGel® Cohesive IIITM implants and Allergen Natrelle® Style 410 implants have the highest density of the available silicone implants and are generally known as Gummy Bear implants (see below).

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Cohesive gel implants are more expensive than basic saline implants, which results in a higher surgical fee for silicone augmentation procedures. During surgery, Cohesive Gel implants also require a slightly larger incision for insertion than saline implants because they are firmer and therefore more difficult to insert (or squeeze) through a small incision. For this reason, insertion is normally performed through an incision in the breast fold (Inframammary), or occasionally through an incision around the areola (Peri-Aerolar). Insertion through an armpit incision (Trans-Axillary) is also possible, but is limited to a maximum implant size of 450 cc.

For further information on Breast Augmentation incisions and scars, please refer here.

Gummy Bear Breast Implants

Form-Stable breast implants, which are otherwise known as Gummy Bear implants, offer unique advantages and have been developed to further address patient concerns regarding the leaking of silicone gel. Their name is derived from the highly (or ultra) cohesive, form-stable consistency of the silicone formulation used, which resembles that of gummy bear candy. When these implants are cut in half, the silicone gel in each half holds together uniformly and retains its shape or form.

This type of silicone gel is therefore used in Shaped (Anatomic or Teardrop) implants, which are designed to replicate the look and feel of a natural breast by having a soft touch and a teardrop appearance. Once implanted, the breast conforms to the shape of these implants, and irrespective of a woman’s body position, overtime this shape and an upright position is maintained with minimal rippling/wrinkling. Other types of implants are subject to the downward force of gravity and adapt to the individual shape of each woman and body position. The main drawback of this form-stability is that Gummy Bear implants feel firmer; however, their density still more closely resembles that of natural breast tissue than saline implants.

 

Breast Augmentation surgery is intended to be fully customizable and with the recent Health Canada approval of these highly cohesive silicone gel implants, patients now have more options. Yet such variety should not worry or confuse you. During your consultation, Dr. Jugenburg will thoroughly analyze your anatomy, medical history and objectives, and ensure you have a good understanding of all your available options.

A Comparison of Silicone and Saline Breast Implants

Benefits of Cohesive (Silicone) Gel Breast Implants:

  1. All Cohesive Gel implants are FDA and Health Canada approved.
  2. Each implant is filled with a thick, cohesive silicone gel formula that holds together uniformly and retains a natural pliability that closely resembles breast tissue.
  3. Cohesive Gel implants suffer from less rippling/wrinkling than saline implants and older liquid silicone implants.
  4. Ideal for women with very little natural breast tissue or fat.
  5. If a Cohesive Gel implant leaks or ruptures, the silicone gel will not be released.
  6. Each implant has a set fill volume for predictable results.
  7. To ensure best long-term results for all patients, all Cohesive Gel implants are covered (free of charge) by a generous manufacturer warranty and lifetime replacement policy: AllerganConfidencePlusPremier®Warranty and Mentor Premier Advantage Limited Warranty.

Benefits of Saline Breast Implants:

  1. Saline implants have been FDA and Health Canada approved for many years.
  2. Each implant is filled with a sterile salt-water solution similar to the fluid that makes up most of the human body (i.e., it is harmless and compatible with the human body).
  3. Saline implants generally have a slightly firmer feel than silicone-filled implants.
  4. All saline implants have a flexible fill volume that can be adjusted by Dr. Jugenburg during surgery to meet the needs of each patient and given the best result.
  5. Ideal for women with slight breast asymmetries.
  6. If a saline implant leaks or ruptures it will be harmless, and since the breast size and shape will noticeably change, it will also be immediately apparent.
  7. The insertion of any given saline implant during surgery requires a smaller incision than that required for a similar size of Cohesive Gel implant.
  8. Saline implants are cheaper than Cohesive Gel implants, which means the total procedure cost for saline implant augmentation is cheaper for the patient.
  9. To ensure best long-term results for all patients, all saline breast implants are covered (free of charge) by a manufacturer warranty and lifetime replacement policy: AllerganConfidencePlus®Warranty and Mentor Standard Advantage Limited Warranty.

A variety of similar options are available for both saline and silicone gel implants to meet the individual needs of each woman:

  1. An extensive range of base widths (diameters) to suit the body size and shape of each woman.
  2. Different implant projection options from low to high profile and an extensive range of sizes to give each woman the look she wants.
  3. Two shape options: Round implants or more expensive Shaped implants (Anatomic or Tear drop).
  4. Two shell surface options: smooth implants or textured implants.

Every woman should also know that whether receiving saline or silicone implants, both types of implants have similar highly durable, elastic and resilient silicone shells that are designed to be highly resistant to rupturing or tearing, and have been thoroughly tested.

Your Breast Augmentation Consultation

Dr. Jugenburg is a highly experienced plastic surgeon who always takes the time to get to know his patients and their needs before committing to any kind of surgery. At your consultation, you will have the opportunity to meet with Dr. Jugenburg, and let him know about the look you want to achieve. The doctor will guide you through the whole breast augmentation process: from the preparations you will need to make, through to the surgical procedure and aftercare. You will have the opportunity to ask any questions and raise any concerns you might have with Dr. Jugenburg and his team of highly qualified and friendly healthcare professionals.

Meet Your Doctor, Dr. Martin Jugenburg

Get in touch with Toronto's foremost plastic and reconstructive surgeon

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