Silicone Breast Implants - Silicone Gel-Filled Implants

Any initial inquiry about breast augmentation surgery has to include consideration of the filler material the implant itself will contain. This is one of the most important decisions that a breast augmentation patient has to make. While the surgeon is able to enhance the size and shape of the patient's breast tissue through the use of breast implants, they are still foreign elements placed in the body. Safety considerations for the patient's long-term health must be taken into account.

 

History of Silicone Breast Implants

In the 1960s, the first silicone filled breast prosthesis, the Cronin-Gerow implant, became available to consumers. Named for the two plastic surgeons who developed it, the implant dramatically increased the safety and effectiveness of enhancement procedure, which had previously relied on injections, and sponge implants that hardened and were rejected by the body. These early breakthroughs were almost immediately used for commercial purposes and by 1962 silicone breast implants were available.

FDA-Approved Silicone Gel-Filled Breast Implants

- (Nov 2011)

  • Allergan Natrelle
  • Mentor MemoryGel

Silicone breast implants became unavailable to the general public following a ruling in 1992 by the Federal and Drug Administration (FDA). This prohibited its approval as a consumer product due to concern over leaks that allowed the silicone to enter the surrounding tissue and the bloodstream. Improvements in the products, however, did lead the FDA to partially lift the ban on silicone breast implants later that same year. The devices then became available to special patients for specific medical reasons like breast reconstruction after a mastectomy.

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Concerns about the effects of silicone on the human body, if it were to circulate, compelled the Food and Drug Administration (FDA) to impose a ban on the availability of silicone breast implants in 1992.

Risks Associated With Silicone Implants?

The FDA did not find any conclusive evidence that silicone breast implants led to higher occurrences of such illnesses as connective tissue disease, immunological disorders, neurological disorders, increased risk of cancer, and capsular contracture; they also did not find enough evidence to prove that silicone breast implants did not cause a higher incidence of these illnesses. Although the FDA studies yielded no results of the harmful effects of silicone implants, concerns about the effects on the human body, if it were to circulate, compelled the Food and Drug Administration (FDA) to impose the aforementioned ban on the availability of silicone breast implants in 1992. This led to saline breast implants becoming the most popular type of implant available.

FDA Approved Silicone Gel-filled Breast Implants

In November 2006, however, the FDA approved two silicone gel-filled breast implants: the Allergan Natrelle and the Mentor MemoryGel. Each manufacturer was required to conduct post-approval studies to characterize the long-term performance and safety of the devices. In June 2011, the FDA issued an Update on the Safety of Silicone Gel-Filled Breast Implants essentially reversing its 1992 decision and taking into account improvements to the newest generation of implant products.

Silicone as a Filler in Implants

Silicone is a primary component found in breast implants. Breast implants contain a silicone shell that contains a filler material, which provides the implant its size and shape. In silicone breast implants, that filler material is silicone and this type of implant is still considered the one that provides the most natural look and feel.

The original claims that led to the implants being taken off the market were inconclusive. Concerns primarily focused on the potential for leakage and the problems that might cause if the silicone migrated to other parts of the body. Although breast implants generally tend to be stable, there are instances when the shell can rupture, for instance as a consequence of physical trauma like that which might result from an automobile accident.

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In November 2006, however, the FDA approved two silicone gel-filled breast implants: the Allergan Natrelle and the Mentor MemoryGel.

Although the FDA were unable to find conclusive evidence supporting these claims, they were also unable to obtain evidence that refuted them. For the sake of safety, the initial 1992 moratorium was imposed. After further study, and improvements in the products being offered, silicone implants were deemed safe to be returned to the market place. The newer generation of silicone gel-filled breast implants are especially useful for a number of specific cases: - Mastectomy patients undergoing reconstructive surgery. - Revision surgery due to complications caused by saline breast implants. - When a mastopexy (breast lift) is performed simultaneously with breast augmentation. - For the correction of a chest wall deformity (ie. pectus excavatum, pectus carinatum, or scoliosis). - Severe asymmetries of the breast.

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