The preliminary information is that out of the 5 to 10 million women world wide with breast implants, 34 have been identified with ALCL. Because this problem seems extremely rare, the FDA has taken a very measured approach.

They are seeking to confirm that these cases of ALCL actually exist, while continuing to support the use of saline and silicone gel breast implants. "The 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."

Patients with breast implants should continue to perform routine self-examinations and consult their plastic surgeon if a problem appears. Further information will be forthcoming. See FDA's findings.