FDA Says Breast Implants Linked to Ra... ( 24 were related to silicon implants sev...)

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FDA Says Breast Implants Linked to Rare Cancer

Date:1/27/2011

, 24 were related to silicon implants, seven to saline implants and the type of implant in the remaining three cases are not known, according to the FDA. In addition, 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 agency said.

The majority of cases the agency is aware of came to light when women went to a doctor complaining of symptoms such as pain, lumps, swelling or anomalies in their breasts. These symptoms were the result of "fluid, hardening of breast area around the implant, or masses surrounding the breast implant," the agency said. ALCL was found by testing the fluid and area around the implant.

Symptoms of ALCL can develop from one to 23 years after a women gets her implants, according to the FDA.

"Women with breast implants who are not showing any symptoms or problems require only routine follow-up," Maisel said. "Physicians should consider the possibility of ALCL if the patient has late-onset and persistent fluid around the implant," he added.

"Women should monitor their implants and report any noticeable changes to their doctors, particularly those that occur after the breast implants are fully healed," Maisel said.

ALCL is usually treated with chemotherapy and radiation, and sometimes surgery, Maisel noted.

"I suspect this has caught the vast majority of plastic surgeons off-guard, as we have not heard anything remotely related to a potential warning before today," said Dr. Jeffrey C. Salomon, an assistant clinical professor of plastic surgery at Yale University School of Medicine.

This rare lymphoma develops in the naturally occurring capsule of tissue that normally forms around the implant, he said. "It is somewhat distressing to surgeons and patients alike but, the overall risk is exceedingly low," Salomon added.

Maisel added that American Society of Plastic Surgeons (ASPS) is working wit
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