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FDA Approves Use of Silicone Gel-Filled Breast Implants (dateline December 3, 2006)

After a 14-year ban, the U.S. Food and Drug Administration (FDA) approved the marketing of silicone gel-filled breast implants made by two companies for breast reconstruction in women of all ages and breast augmentation in women ages 22 and older. The products are manufactured by Allergan Corporation (formerly Inamed Corporation) and Mentor Corporation.

"FDA has reviewed an extensive amount of data from clinical trials of women studied for up to four years, as well as a wealth of other information to determine the benefits and risks of these products," said Daniel Schultz, MD, FDA Director for the Center for Devices and Radiological Health, in a news release. "The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices. This information is available in the product labeling and will enable women and their physicians to make informed decisions."

The FDA's decision to approve the use of silicone gel-filled breast implants was based on a thorough review of studies by Allegan and Mentor Corporations, a review of studies by independent scientific bodies, and deliberations of advisory panels of outside experts that heard public comment from hundreds of stakeholders. The FDA also performed inspections of each company's manufacturing facilities to determine that they comply with FDA's Good Manufacturing Practices. According to the FDA, the majority of women in these studies reported being satisfied with their implants.

In 1992, the FDA imposed a ban on the general use of silicone gel-filled breast implants in the United States. The banned stemmed from concerns about the safety of silicone implants after manufacturing defects and implant misuse led to silicone leakage and rupturing in many patients. When silicone gel is free in breast tissue, it may move to nearby tissues or to the lymph nodes. Some physicians attributed silicone leakage to immune-related disorders and other sicknesses. Many women who experienced silicone leakage reported:

  • breast pain
  • fatigue
  • myalgias (muscle pain)
  • arthralgias (joint pain)
  • hair loss
  • memory loss

There was much controversy surrounding the FDA's ban on silicone breast implants. Many medical experts doubted silicone implants caused any significant medical disease. However, radiologists do worry about the difficulty in detecting breast cancer in breast with implants (saline or silicone). Click here for below on breast imaging after reconstruction for more information.

"The silicone breast implant is one of the most extensively studied medical devices," said Schultz. "We now have a good understanding of what complications can occur and at what rates. We also know that women who get these devices will probably need to have additional breast implant surgery at least once. This is valuable information for women who may be considering these products."

The FDA will continue to monitor silicone gel-filled breast implants by requiring Allergan and Mentor Corporations to conduct a large post-approval study following about 40,000 women for 10 years after receiving the implants. The FDA will also require that full information about the risks and benefits of the implants be included in the package and patient labeling. Other requirements of the approval include: a focus group study of the patient labeling; further laboratory studies to study the types of implant failures; and following each implant in the event, for example, that health professionals and patients need to be notified of updated product information.

According to the FDA, risks and complications of silicone gel-filled breast implants include the following:

  • breast implants are not lifetime devices and a woman will likely need additional surgeries on her breast at least once over her lifetime;
  • many of the changes to a woman's breast following implantation are irreversible;
  • rupture of a silicone gel-filled breast implant is most often silent, which means that usually neither the woman nor her surgeon will know that her implants have ruptured;
  • and a woman will need regular screening MRI examinations over her lifetime to determine if silent rupture has occurred.
Source: U.S. Food and Drug Administration, 2006

The mandatory FDA labeling will state that "a woman should have her first MRI three years after her initial implant surgery and then every two years thereafter." The FDA also warns that the cost of MRI screening over a woman's lifetime may exceed the cost of her initial surgery and may not be covered by medical insurance. Finally, the labeling will state that if implant rupture is noted on an MRI, the implant should be removed and replaced, if needed.

Women should be aware that saline filled breast implants have risks too. The most common complication with breast implants is capsular contracture: the scar or capsule around the implant begins to tighten and squeezes down on the soft implant, causing the breast to feel hard. Capsular contracture may be treated with additional surgery to remove the scar tissue. Occasionally, patients with capsular contracture may have to have the breast implant removed and replaced with a new one. Other rare complications from general surgery may also occur during breast reconstruction, including: bleeding, fluid collection, excessive scar tissue, infection, and problems with anesthesia. Women who smoke may experience a slower rate of healing or more noticeable scars since nicotine often interferes with the body's natural healing process. Rarely, these complications may require additional surgery.

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