FDA issues warning: Breast implants may cause cancer



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Posted on January 26, 2011 at 6:17 PM

Updated Wednesday, Jan 26 at 9:23 PM

An alarming warning for every woman who has breast enhancement surgery or is considering having the procedure.

The Food and Drug Administration is investigating a possible risk of cancer associated with saline or silicone implants.

Plastic surgeon are now being asked for information on patients. The FDA wants to create a registry to better track any possible link between breast implants and anaplastic large cell lymphoma or ALCL.

Right now 60 cases have been reported worldwide, but there is concern that others victims may be out there and not now about the risk.

A local plastic surgeon at University of Texas Southwestern knew this announcement was coming. He said the announcement has been in the works for some time now.

Dr. Jeffrey Kenkel with UT Southwestern says ALCL is rare. The problem, he said, is not the implant itself, but the scar capsule.

"Its between this red muscle and the implant itself," said Dr. Kenkel.

The body creates a capsule to protect itself from the implant. That is where the lymphoma is forming.

but researchers believe it is treatable.

"The reassuring thing about this whole process is if you go into surgery and remove this capsule, the problem seems to go away," Kenkel said.

The lymphoma is localized and does not spread throughout the body. The facts are alarming enough for the FDA to start a registry to better track the problem.

"There is a rare occurrence," Kenkel said. "We need to take a better look at it. We need to prospectively look at data so we can follow these patients and see exactly what is happening."

So far the data is inconsistent. Some cases are thorough, others are not. Dr. Kenkel went to a summit on the topic last summer.

"I think the take away on this is that breast implants are safe.," Kenkel said. "They are the most studied medical device in history."

In the coming months you can expect to see changes on product labels, when it comes to implants.

The FDA is already working with manufacturers to update their products complete with the full warning.

The lymphoma is unique to the breast. It does not’t seem to be a problem with implants in other parts of the body.

Email: sslater@wfaa.com