Breast Implant Risk Was Downplayed by Surgeons, Group Says

Plastic surgery organizations have drawn criticism from U.S. regulators by trying to downplay the risk of cancer with breast implants, a consumer group said.

The American Society of Plastic Surgeons and the American Society of Aesthetic Plastic Surgery said on their websites that a rare form of cancer tied to Allergan Inc. and Johnson & Johnson implants was benign and could be cured with surgery, the Public Citizen consumer group said today. The Food and Drug Administration talked to the organizations at the request of Public Citizen and the information was removed.

About 60 cases of anaplastic large-cell lymphoma have been reported globally in women with breast implants, including 34 published in studies from January 1997 to May 2010, the FDA said Jan. 26. The agency hasn’t decided on an optimal treatment for these women or what risk factors or prognosis they have.

“While ASPS and ASAPS are independent organizations that the FDA does not regulate, we are committed to assuring that health care providers and patients receive accurate information,” Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a Feb. 28 letter to Public Citizen.

The plastic surgery organizations say the FDA didn’t require the information to be removed from their websites and that it was replaced with newer information.

‘Proactive’ Effort

“It was never our intention to downplay the risk of a very rarely occurring cancer associated with breast implants,” said Phil Hayes, a spokesman for the American Society of Plastic Surgeons, in an e-mail. “We regret that our word choice caused confusion, and we voluntarily removed the webinar from our website.”

Allergan, of Irvine, California, and the charitable Allergan Foundation each have given at least $25,000 to the American Society of Plastic Surgeons this year, according to the association’s website. The Ethicon, Ethicon Endo-Surgery and Mentor divisions of New Brunswick, New Jersey-based J&J have given at least $25,000 each, according to the website.

Several companies, including Allergan and Mentor, have provided educational grants to the aesthetic plastic surgery organization, said Felmont Eaves, the president of the American Society of Aesthetic Plastic Surgery, in an e-mail. Neither company provided funding for the information removed from the website, he said.

The FDA is urging doctors to report confirmed cases while it works with the plastic-surgeon society and others to develop a registry to track women who receive breast implants.

“As the FDA moves forward with these plans, it is essential that the agency closely monitors the control of the registry to ensure that the integrity of the data being collected is not corrupted by those with significant conflicts of interest,” said Michael Carome, deputy director of health research at Public Citizen, in a statement.

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