乌鸦传媒

WASHINGTON -- An FDA review has identified a possible link between breast implants and a rare form of non-Hodgkin's lymphoma.

The review uncovered about three dozen cases of anaplastic large-cell lymphoma (ALCL) in women with breast implants. Most of the cases (27 of 34) involved silicone-filled devices.

According to a statement posted on the FDA website, agency officials are aware of another two dozen or so cases of ALCL among implant users worldwide.

Although the implant-ALCL link requires confirmation, "the FDA believes that women with breast implants may have a very small but increased risk of ALCL. Because the risk of ALCL appears very small, FDA believes that the totality of evidence continues to support a reasonable assurance that FDA-approved breast implants are safe and effective when used as labeled."

"We need more data and are asking that healthcare professionals tell us about any confirmed cases they identify," William Maisel, MD, of the FDA Center for Devices and Radiological Health, said during a press briefing.

"We are working with the American Society of Plastic Surgeons and other experts in the field to establish a breast implant patient registry, which should help us better understand the development of ALCL in women with breast implants."

The agency also will work with implant manufacturers to update product labeling information for patients and healthcare professionals.

The FDA announcement came after completion of a review of relevant literature published from 1997 through May 2010. The agency also reviewed information from scientists, implant manufacturers, and regulatory authorities in other countries.

The literature review first came to light a year ago when researchers at the University of Southern California (USC) in Los Angeles reported the findings at the American Association of Plastic Surgeons meeting. In addition to the 34 cases cited by the FDA, the study uncovered six more cases of ALCL among women with breast implants.

Late peri-implant seromas accounted for 25 of the 34 published cases, which also included six patients with severe capsular contracture and three with pericapsular tumor masses. In their meeting abstract, Garry Brody, MD, and his USC colleagues pointed out that "not all late seromas and contractures are malignant but one should be aware of the possibility and have the fluid and capsule analyzed."

"As these patients represent only a minuscule fraction of the total of the implant population with these particular implants, a statistically valid relationship cannot as yet be established," Brody and colleagues wrote in conclusion. "To date, the association can only be considered as remarkably coincidental."

At the press briefing, Maisel echoed the emphasis on cautious interpretation of the findings.

"Women with breast implants who are not showing any symptoms or problems, such as pain, lumps, swelling, or asymmetry, require only routine follow-up," said Maisel.

"Today the agency is recommending that healthcare professionals should consider the possibility of ALCL if the patient has late onset and persistent fluid around the implant. By sending a sample of this fluid to a pathology lab, a healthcare professional can test for ALCL.

"Women with breast implants who are not showing any symptoms or problems do not need to change their healthcare routine. ALCL has occurred in a very small number of women compared to the millions who have implants. FDA is not recommending the routine removal of breast implants in patients without symptoms or other abnormalities."

Other facts stated during the press briefing included:

• Most of the ALCL cases were diagnosed after silicone implants returned to the market in 2006.
• The diagnoses tended to occur long after the implant procedure and healing, a median of eight years after implantation.
• Most lesions arose in the fibrous capsule that formed around the implant.
• A majority of cases involved implants for breast augmentation as opposed to reconstruction after breast cancer surgery.

According to the FDA, five to 10 million women worldwide have breast implants. Data from the National Cancer Institute suggest that one in 500,000 women in the U.S. develops ALCL each year. ALCL in the breast is even more rare, an estimated three per 100 million women per year.

Two leading manufacturers of breast implants weighed in with responses to the FDA announcement.

According to a statement from Allergan in Irvine, Calif., company officials support the FDA recommendations, "advising physicians to remain diligent in their monitoring of any symptoms of ALCL in breast implant patients, regardless of its rare occurrence, and not to recommend prophylactic breast implant removal in patients without symptoms or other abnormalities."

"Allergan has been in ongoing dialogue with the FDA and all other regulatory authorities around the world about these rarely reported cases of ALCL in patients with breast implants. The company also sponsored a scientific advisory committee to independently evaluate reports of suspected ALCL in patients with breast implants and carefully assess and review each case."

According to a statement from the Mentor division of Johnson & Johnson, the company concurs with the FDA's position that the body of evidence supports the safety and efficacy of approved implants when used as labeled.