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Silicone Safety

The new generation of silicone breast implants: silicone made safe.

Get all the information you need about the new generation of silicone breast implants before choosing what type of implants to use for your breast augmentation. When faced with such an important decision, knowing all the facts will lead to the most successful outcome.

Mentor has on-going clinical studies to evaluate the long-term safety and effectiveness of both our silicone breast implants, MENTOR® MemoryGel® Breast Implants and MENTOR® Saline Breast Implants. Mentor currently has seven silicone gel breast implant clinical studies in progress. Over 200,000 women have participated in Mentor studies in order to provide a significant body of clinical evidence demonstrating the safety and effectiveness of silicone-filled breast implants. Mentor remains committed to providing objective, clinical information about breast implant safety to drive an informed choice and give women beautiful results.

Fortunately, the scientific community respects our commitment to safety. Both MENTOR® MemoryGel® Breast Implants and MENTOR® MemoryShape Breast Implants are FDA approved for breast augmentation. The Institute of Medicine, in a highly respected study, concluded that: “There is no evidence that silicone implants are responsible for any major diseases of the whole body. Women are exposed to silicone constantly in their daily lives.”1

Silicone Used Today, Versus Silicone Of The Past

Silicone gel-filled breast implants have undergone changes over time to meet increasingly sophisticated consumer expectations. The first silicone breast implants used thick shells and contained firm gel. The second generation of implants (introduced in the late 1970’s) had thinner shells and used less firm gel to address concerns of patients and surgeons who believed that implants were too firm, palpable, and visible.

In the mid 1980’s, concerns related to rupture rates of the second generation thinner-shelled implants led manufacturers to introduce a third generation of implants. The shell and gel of these implants are slightly thicker but still soft.

Today these third generation silicone gel filled breast implants are typically referred to as cohesive gel implants. Mentor’s products have kept pace with the ever-evolving expectations of surgeons and women who desire a safe, soft gel to retain the natural feel that resembles actual breast tissues.

Silicone Exposure

The amount of silicone released from MENTOR® MemoryGel® Implants is extremely minimal. It is less than is absorbed from daily consumer products containing silicone. (For example, silicone can be found in many common household items, such as polishes, suntan and hand lotion, antiperspirants, soaps, processed foods, waterproof coatings, and chewing gum.)

  • Equal to approximately 1/1000th the weight of the head of a straight pin
  • More than a million fold below established safety limits, based on the results of studies presented to the FDA.
  • More than a hundred-fold below absorbed daily exposures to the same silicone from commonly used consumer products, such as antiperspirants, skin care lotions and hair care products.

There you have it, everything you need to know about silicone safety and MENTOR® MemoryGel® Implants and MemoryShape Breast Implants: safe, reliable, and FDA approved.

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1Institute of Medicine, National Academy of Medicine 2007. Information for women about safety of silicone breast implants (full article www.iom.edu).