On Tuesday, the Food and Drug Administration (FDA) announced a possible link between a rare form
of cancer known as Anaplastic Large Cell Lymphoma (ALCL) and breast
implants.
FDA scientists reached that conclusion after examining scientific
literature that focused on cases of ALCL in 34 women with breast
implants -- as well as information from agency reports,
international regulatory agencies, scientific experts, and breast
implant manufacturers.
This week’s announcement by the FDA left some people
wondering, “What took them so long?”
Public
Citizen, a consumer advocacy watchdog group, said they brought
this issue to the FDA over 22 years ago.
"The petition contains quotes from memos written by FDA employees who were very concerned about these findings and wanted the public to be informed about this problem. This was the original basis for our asking the FDA to ban silicone gel breast implants,” said Wolfe.
Wolfe said even though the FDA’s announcement is limited to lymphomas, not sarcomas, sarcomas are still a possible threat, too. A study published in the journal Human Pathology in November 2009 found sarcomas in five women with breast implants.
"Animal evidence of carcinogenicity, especially with the highly malignant tumors found in these studies, should be taken more seriously than the leadership in the FDA has done over the past two decades," said Wolfe.
In response to the possible cancer risk associated with breast implants, the American Society of Plastic Surgeons (ASPS) announced Wednesday they’re collaborating with the FDA to establish a national registry for breast implants.
The ASPS and the FDA agree this extremely rare form of lymphoma is not breast cancer. Of the estimated 10 million implants worldwide, only 34 cases of ALCL have been identified since 1989.
While lymphomas can appear anywhere in the body, this condition appears in the scar tissue that forms around the breast implants. At this time both the FDA and ASPS remain confident that breast implants are safe and effective.
“ASPS shares the FDA’s commitment to patient safety, but we also want to make certain this information does not raise false alarms with our patients,” Phillip Haeck, MD, ASPS President, said.
“We’ve been down this path before. For nearly 20 years American women were denied access to their choice of breast implants because of false claims and unfounded science. We are determined this shouldn’t happen again.”
ASPS recommends that women with breast implants should continue their normal routine in medical care and follow-up, specifically regular self examination and mammography when appropriate.
Women with breast implants should watch for changes in their breasts such as pain and swelling and contact their plastic surgeon if they have questions.
