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FDA urged to reject silicone implants

U.S. regulators should deny applications to sell silicone gel-filled breast implants because the manufacturers have not met the legal benchmark for proving safety, 20 consumer groups and individuals said in a petition.
/ Source: Reuters

U.S. regulators should deny applications to sell silicone gel-filled breast implants because the manufacturers have not met the legal benchmark for proving safety, 20 consumer groups and individuals said in a petition released Tuesday.

Inamed Corp. and Mentor Corp. are trying to win Food and Drug Administration approval to resume widespread sales of silicone breast implants for the first time since 1992.

The petitioners said neither company has met the requirement in federal law that makers provide a “reasonable assurance” that the implants are safe.

“Even if interpreted in the manner most favorable to Inamed and Mentor, the data regarding safety are inconclusive, and FDA therefore must deny both applications,” said the petition, signed by Public Citizen, the National Organization for Women and others.

In April, an FDA advisory committee voted 5-4 against Inamed’s implants, while urging approval for Mentor’s implants by a 7-2 vote. The FDA is considering those recommendations and is expected to make a final decision around mid-July.

Many women believe leaking silicone from ruptured implants has made them sick with debilitating illnesses, but studies have failed to find a connection between the devices and chronic disease. The implants can, however, cause painful scarring and other complications in the breast area.

FDA spokeswoman Kathleen Quinn said the agency will carefully review the petition.

Spokespeople for Mentor and Inamed could not immediately be reached for comment.

Both companies previously have defended their silicone implants as safe and more natural-looking than saline-filled breast implants, the only option for most U.S. women. Silicone implants are allowed through clinical trials for breast cancer patients and other women who need reconstruction surgery.