ABC World News reported, “An important health warning tonight from the FDA about a possible link between breast implants and a rare form of cancer.” ABC (Stark) added, “The government says they may be linked to a rare form of lymphoma. … There are 60 cases worldwide, in as many 10-million women with implants.”
The Washington Post reports that the FDA on Wednesday announced it had “detected a possible association between saline and silicone gel-filled breast implants and anaplastic large cell lymphoma (ALCL)” The agency said most women with implants “do not have to have them removed or take any other steps,” but they should “immediately seek medical care” if they develop “unusual problems,” such as “swelling or pain around the implant.”
According to the AP, the FDA based its warning on a review of “scientific literature going back to 1997 along with information provided by international governments and manufacturers.” Most of the cases were “reported after patients sought medical care” for problems “around the surgical site.”
The Wall Street Journal reports the FDA has identified 60 ALCL cases in women who had breast implants, of which 34 cases have thus far been verified, according to a statement released by the agency.
HealthDay noted that 24 of the cases were “related to silicone implants, seven to saline implants and the type of implant in the remaining three cases are not known,” according to the FDA. The agency also said that “19 of the implants were inserted for cosmetic reasons and 11 were used in reconstructive procedures. The reasons for the other four procedures are not known.”
The New York Times reports in some cases, simply “removing the implant and scar tissue gets rid of the disease, but some women might need chemotherapy and radiation,” said Center for Devices and Radiological Health Deputy Director Dr. William Maisel. He noted that although 60 cases is “a tiny number compared” with the number of women who have implants, it is an excess when “compared with the usual incidence.” ALCL in the breast is “normally found in only three in 100-million women who do not have implants.”
Bloomberg News says, “Allergan Inc. and Johnson & Johnson” breast implants were linked to ALCL by US investigators. Allergan, the “maker of Natrelle gel and saline breast implants,” and J&J’s “Mentor division each control about half the market for breast implants.” Dr. Maisel told Bloomberg News that the agency is “working with manufacturers to revise their product labeling and plans to release an analysis of company-sponsored studies ‘later this spring.’”
According to MedPage Today, Allergan released a statement, saying “company officials support the FDA recommendations” and advising all physicians to “remain diligent in their monitoring” for ALCL symptoms. A statement from the J&J Mentor division says 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.”
From the American Association for Justice news release.