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FDA Approves Saline Breast Implants Despite Risks (dateline May 17, 2000)

The U.S. Food and Drug Administration (FDA) announced that it has approved the general use of saline (salt water) filled breast implants made by two companies despite the high rate of complications.  Mentor Corporation and McGhan Medical Corporation will be allowed to continue making saline implants, but three smaller companies must quit selling implants in the United States by May 15, 2000.  The FDA has put together a booklet explaining the risks of breast implants and is now requiring plastic surgeons to give patients the booklet and discuss possible complications before implants are placed. 

The FDA’s decision to approve saline breast implants was made based on research conducted by Mentor and McGhan Medical that showed that the majority of women are satisfied with their implants despite complications.  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.

The FDA wants women to be informed of the possible complications of saline implants before undergoing surgery.  “Women should understand that breast implants do not last a lifetime,” said David Feigal, head of the FDA’s Center for Devices and Radiological Health, in a public statement.

The risks of breast implants:

  • Over 20% of patients who have implants placed for cosmetic reasons need additional surgery within three years due to infection or painful scar tissue.
  • Nearly 40% of patients who have implants placed after breast cancer surgery need additional implant surgery within three years.
  • Up to 73% of patients in one study experienced at least one side effect of implants (such as pain, leakage, or hardening of scar tissue).
  • Patients who have implants removed due to complications may experience breast skin dimpling or puckering if new implants are not placed.

Some women’s health advocates are criticizing the FDA’s approval of saline implants.  Diana Zuckerman of the National Center for Policy Research for Women and Families said the standard of safety at the FDA has hit a new low.  Others object because the complication rates seem too high to justify approval. 

“With the data that have been presented, women and their physicians will be able to make informed decisions about whether the benefits are worth the risks,” said FDA commissioner Jane E. Henney, MD, in a public statement. 

Saline implants have been on the market in the United States since 1976 without FDA approval because of a provision that allowed products sold before FDA regulation to remain available to the public.  The FDA asked breast implant makers to research the risks of saline implants after the organization banned the general use of silicone-filled implants in 1992.  Click here to learn more about the ban on silicone breast implants. 

Saline implants are currently the only option available to women who want to enhance the size of their breasts for cosmetic reasons.  Many breast cancer patients may undergo muscle flap reconstruction , which involves using their own tissue to rebuild the contour of the breast.