Breast Implant Answers: Understanding Silicone Gel-Filled Breast Implants

Understand the difference between silicone gel-filled and saline-filled breast implants and important factors to consider about breast implants when discussing either option with your physician.

Comparing Silicone Gel-Filled and Saline-Filled Breast Implants
Silicone Gel-Filled and Saline-Filled Breast Implants: Options Available to Women Worldwide
Two FDA-Approved Breast Implant Options for Women in the United States
Advancements in Safety and Technology of Silicone Gel-Filled Breast Implants
The Evolution of Silicone Gel-Filled Breast Implants

Women in the United States considering breast implant surgery now have the option of saline-filled or silicone gel-filled breast implants. The United States Food and Drug Administration (FDA) has approved both types of breast implants after determining that each are safe and effective options for women undergoing breast augmentation, reconstruction or revision surgery. Ultimately, it is up to each woman, along with her surgeon, to decide what breast implant option will provide the look and outcome desired from the surgery.

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Augmentation surgery is for women who want to enhance or change their breast size and shape for cosmetic purposes.

Reconstruction surgery is for women seeking to replace/restore breast tissue that has been lost due to cancer or trauma, or tissue that has failed to develop properly due to a severe breast abnormality.

Revision surgery is for women who want to correct or modify an original breast implant surgery through removal and replacement of a breast implant device.

It is important to know that both silicone gel-filled and saline-filled breast implants have an outer covering (shell) made of silicone elastomer (a rubber-like elastic material), and that different types of silicone have been used for years in many other medical devices, including pacemakers, heart valves and artificial joints. Because silicone is used in many life-saving medical devices, it has been studied extensively for decades. In fact, silicone gel-filled breast implants are among the most-studied FDA-approved medical devices in existence.

Two key differences between saline-filled and silicone gel-filled breast implants are the material that fills the inside of the breast implant and the technique used to implant them during surgery.

Saline-filled breast implants are filled with saline, or a salt water solution that is compatible with the human body. During breast implant surgery, the empty breast implant shell is placed inside the woman’s body and then filled with saline – enough to achieve the desired result. On the other hand, silicone gel-filled breast implants already contain silicone gel before being implanted inside a woman’s body and therefore their volume cannot be adjusted during surgery.

Learn more about the unique technological characteristics of silicone gel-filled breast implants

Both silicone gel-filled and saline-filled breast implants have been available to women in more than 60 countries for more than 25 years. During this time, in the countries where both silicone gel-filled and saline-filled breast implants were widely available to women, silicone gel-filled breast implants became the preferred breast implant option among women. For example, in Europe, where both silicone gel-filled and saline-filled breast implants have been available for approximately 30 years, 9 out of 10 women who undergo breast augmentation surgery choose silicone gel-filled breast implants. Today, more than one million women around the world have chosen Allergan’s silicone gel-filled breast implants alone to enhance or restore their breast shape.

Click here to see the evolution of silicone gel-filled breast implants

Until November 2006, saline-filled breast implants were the only commercially available option for women in the United States who were considering breast implant surgery. Silicone gel-filled breast implants were available only through limited clinical studies for women considering breast augmentation, for reconstructive surgery after a mastectomy, or for women considering revision surgery to replace breast implants they already had.

On November 17, 2006, the United States Food and Drug Administration (FDA) approved the option of silicone gel-filled breast implants for women considering breast augmentation surgery who are at least 22 years old. FDA approval also enabled women seeking breast reconstruction or revision (implant replacement) surgery the option of silicone gel-filled breast implants, regardless of age and without the need to be involved in a clinical study.

Over the several decades since silicone gel-filled breast implants were first invented, researchers, scientists, physicians and other medical professionals have conducted extensive research and rigorous scientific review of the safety of these medical devices. FDA reviewed results from much of this research, as well as information about the long-term effects and durability of silicone gel-filled breast implants, when determining whether they were a safe and effective option for women considering breast implant surgery in the United States.

Healthcare companies invest heavily in research and development so that they can create new and advanced medical devices or pharmaceutical products that meet the changing needs of patients and physicians. It is this research and development that lead to advancements in the safety and effectiveness of medical devices, such as breast implants.

Like other medical devices on the market today, silicone gel-filled breast implants have evolved as a result of research and development and innovations in technology. For example, the silicone gel-filled breast implants available to women today have a thicker and more durable outer covering (shell), and a more cohesive silicone gel filler than earlier implants. These innovations were designed to improve both the overall strength and durability of silicone gel-filled breast implants, as well as a woman's satisfaction with her breast shape and size over time.

Read an expert’s opinion on the strength and durability of silicone gel-filled breast implants

Find out more about the technology behind silicone gel-filled breast implants

Below is a timeline highlighting key milestones in the development of silicone gel-filled breast implants in the United States.

1976The Medical Device Amendments were enacted, giving the United States Food and Drug Administration (FDA) authority to regulate medical devices such as breast implants, which were already available.

1991The FDA requires that manufacturers of silicone gel-filled breast implants submit Pre-Market Approval applications (PMAs) with data showing a reasonable assurance of safety and effectiveness of the implants.

1992The FDA calls for a voluntary moratorium (delay) on the use of silicone gel-filled breast implants until new safety information could be thoroughly reviewed.

Later that year, the FDA lifts the voluntary moratorium on silicone gel-filled breast implants. The FDA also announces its decision to allow women access to silicone gel-filled breast implants only under controlled clinical studies for reconstruction after mastectomy, correction of congenital deformities, or replacement of ruptured silicone gel-filled implants due to medical or surgical reasons. Until the clinical studies (adjunct studies) can be submitted and reviewed, the FDA authorizes temporary limited distribution of silicone gel-filled implants for reconstructive patients on an urgent-need basis. The FDA requires companies to later conduct clinical trials for a limited number of patients (these were called Core or Investigational Device Exemption (IDE) studies).

1999The Institute of Medicine (IOM) releases its landmark report, concluding that women with silicone gel-filled breast implants demonstrate no higher incidence of specific health conditions (connective tissue diseases, cancer, neurological diseases and other systemic conditions) than women without silicone gel-filled breast implants.
Read the IOM Report

2000The FDA officially approves saline-filled breast implants as an option for women considering breast augmentation or reconstruction. Saline-filled breast implants were available prior to the enactment of the Medical Device Amendment in 1976.

2002 - 2003The two companies manufacturing silicone gel-filled breast implants in the United States submit PMA applications to the FDA, requesting approval to freely market these implants in the United States.

November 2006The FDA concludes sufficient safety data on silicone gel-filled breast implants has been collected and provided by the makers of the devices, and grants the approval of silicone gel-filled breast implants for augmentation (for women who are at least 22 years old), reconstruction and revision surgery in the United States.