A U.S. Food and Drug Administration (FDA) advisory com Breast Implants Often Require Additional Surgery Due to Complications (dateline October 12, 2002) | Breast Health News | Imaginis - The Women's Health & Wellness Resource Network

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Breast Implants Often Require Additional Surgery Due to Complications (dateline October 12, 2002)

A U.S. Food and Drug Administration (FDA) advisory committee heard testimony from two manufacturers of saline breast implants which highlighted the high rate of complications with implant surgery. According to federal officials, up to 25% of women who obtain saline breast implants for cosmetic reasons must undergo additional surgery within five years, and both implant manufacturers said that 43% of breast cancer patients who have reconstructive surgery with implants have a second operation within a few years. The testimony is required by the FDA’s 2000 decision to allow the continued manufacturing of saline breast implants.

Breast implant surgery has been a common operation in the United States since implants first appeared on the market in 1976, before FDA product regulation. Because of a provision that allowed products sold before FDA regulation to remain available to the public, implants stayed on the market despite a lack of evidence illustrating their safety. In 1992, the FDA banned the general use of silicone gel filled breast implants after questions arose concerning their safety.

In May 2000, the FDA approved the continued manufacturing of saline breast implants by two manufacturers, Mentor Corporation and McGhan Medical Corporation (though the FDA required three smaller manufacturers to stop making implants). That decision was based upon research conducted by Mentor and McGhan Medical that showed that the majority of women are satisfied with their implants despite complications. As a provision of approval, the FDA requested that the companies conduct 10 years of studies on implant safety.

In an update on study data presented to an FDA advisory committee, panelists were disappointed with information from Mentor, who aimed to study 1,600 women with breast implants but were only able to track around 60 of the women. Mentor said that 20% of the women who received implants to augment their breast size underwent a second surgery within a few years due to capsular contracture (see explanation below). McGhan Medical, whose study sample included 1,100 women, reported similar findings, indicating that 25% of women who received implants for cosmetic reasons had additional surgery. Both manufacturers said that 43% of breast cancer patients who underwent breast reconstruction with implants required additional surgery.

Capsular contracture is the most common complication with breast implants. It occurs when scar tissue that forms around the implant begins to tighten and squeeze down on the implant, causing the breast to feel hard. Capsular contracture can be treated with additional surgery to remove the scar tissue. In some cases, patients with capsular contracture may have to have the breast implant removed and replaced with a new one.

The FDA will update its manual on breast implants to include the information learned from the latest study data. The handbook, which is required to be given to women prior to implant surgery, contains the latest information on breast implants and is designed to assist women in making informed decisions about whether or not to get breast implants. The publication discusses in detail the risks associated with breast implants as well as the implant operation itself.

The following side effects are possible with breast implants:

  • Capsular contracture (hardening of scar tissue around the implant)
  • Calcium deposits in the breast tissue around the implant (usually non-cancerous but occasionally have to be surgically removed to assure they do not indicate cancer)
  • Infection around the implant
  • Hematoma or seroma (blood or fluid trapped in the wound)
  • Delay in healing
  • Shifting of implant (further surgery may be necessary)
  • Temporary or permanent changes in the feeling of the nipple or breast (some women report areas of increased or decreased sensitivity or numbness near the incision)

According to the American Society of Plastic Surgeons (ASPS), approximately 15,000 breast cancer patients chose to have breast reconstruction using implants after mastectomy in 1999 while around 135,000 women had implant surgery for cosmetic reasons.

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