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Posted at 11:21 AM ET, 01/26/2011

Breast implants linked to rare lymphoma

By Rob Stein

Federal health officials announced Wednesday that they were investigating a possible association between saline and silicone gel-filled breast implants and very rare form of cancer known as anaplastic large cell lymphoma (ALCL).

In a statement released in advance of a briefing for reporters, the FDA said it had found a "a very small but significant risk of ALCL in the scar capsule adjacent to the implant" after reviewing data worldwide and was asking doctors to report any cases of ALCL in women with breast implants.

"We need more data and are asking that health care professionals tell us about any confirmed cases they identify," said William Maisel, the FDA's chief scientist in a written statement. "We are working with the American Society of Plastic Surgeons and other experts in the field to establish a breast implant patient registry, which should help us better understand the development of ALCL in women with breast implants."

In the meantime, the agency planned to work with breast implant manufacturers warn women considering implants of the possible risk.

The announcement was prompted by a a review of scientific literature published between January 1997 and May 2010 and "information from other international regulators, scientists, and breast implant manufacturers," the FDA said. The literature review identified 34 unique cases of ALCL in women with both saline and silicone breast implants. So far, the FDA has found a total of only about 60 cases of ALCL in women with breast implants worldwide, according to the statement. But the agency stresssed ":this number is difficult to verify because not all cases were published in the scientific literature and some may be duplicate reports."

An estimated 5 million to 10 million women worldwide have breast implants.

Most cases reviewed by the FDA were diagnosed when patients sought medical treatment for implant-related symptoms. such as pain, lumps, swelling, or "asymmetry that developed after their initial surgical sites were fully healed," the FDA said. These symptoms were due to collection of fluid, hardening of breast area around the implant or masses surrounding the breast implant.

ALCL is diagnosed in about one out of 500,000 women in the United States each year, the FDA said. ALCL located in breast tissue is found in only about three out of every 100 million women nationwide without breast implants

The FDA stressed that there was "no need for women with breast implants to change their routine medical care and follow-up. ALCL is very rare; it has occurred in only a very small number of the millions of women who have breast implants."
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"Women should monitor their breast implants and contact their doctor if they notice any changes," the FDA said. "Women who are considering breast implant surgery should discuss the risks and benefits with their health care provider."

For more information, click here and here and here.

By Rob Stein  | January 26, 2011; 11:21 AM ET
Categories:  FDA  
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Comments

Fun bags not so fun.

Posted by: lingering_lead | January 26, 2011 12:18 PM | Report abuse

Looks like we're in for a huge decline in the female populations of Long Island and Los Angeles. And Jersey might be a nice place to live again.

Posted by: josetucson | January 26, 2011 1:39 PM | Report abuse

Well when you put foreign things like implants in your body that are made out of chemicals and plastic..theres a good chance you are going to get something.

We're going to find out years and years from now that most cancers are caused by things we created, from chemicals to drugs, etc.

Posted by: cavatellie | January 26, 2011 1:52 PM | Report abuse

Wow. Putting a foreign object in one's body might have some negative consequences. Who'da thunk it?

Posted by: didnik | January 26, 2011 1:53 PM | Report abuse

A woman who gets an implant for any other reason than reconstructive surgery after breast cancer or a car accident is an idiot.

Posted by: jjedif | January 26, 2011 2:28 PM | Report abuse

Lymphoma jokes! ha ha ha ha. Not.So.Much.

99% of women look just great the way they are, but will slap you or call HR if you tell them.

Posted by: mikey999 | January 26, 2011 2:29 PM | Report abuse

This is so sad...and I hope that the finding is wrong and that women are not threatened. On the other hand, who could possibly think that sewing plastic bags full of stone grease into your body would be good for you?

Posted by: kstack | January 26, 2011 2:45 PM | Report abuse

Having researched breast implants as a reporter, I did not want them when seeking reconstruction of two breasts I was losing to cancer in 2005.

If not for legal obstacles, I would list for you here the top, prominent breast and breast plastic surgeons in the Washington metro area, including the head of breast surgery at one of the nation's very, very most "prestigious" HOsPitals (he was eager to do on me what he called an "experiment" with implants), who looked me straight in the eye and lied.

They said I had to have implants because I was too thin to have fat taken from my belly for breast reconstruction. (Called a DIEP operation.) That was true. But every single one of these men and women had to know there was a world-famous surgeon, Bernard Chang at Mercy Hospital in Baltimore, who could take the fat from my buttocks. (An S-GAP procedure.)

By not telling me about Dr. Chang, these rich charlatans with medical degrees lied by omission and treated my life as just another piece of business. During the time it took me to find Dr. Chang myself, the cancer spread. (I am currently in remission for stage IIIa disease, early advanced breast cancer. The next step is stage IV, out the door.)

For those women who want implants, whether for cosmetic or breast reconstruction reasons, that's their choice and I honor it. But do not expect to get the truth from the many M.D.s whose chief concern is their purse.

Posted by: peartree | January 26, 2011 4:00 PM | Report abuse

The anti-socialist in me thinks this 'rare' link may just be a step in the 0bammycare plan to treat implants and anything they're linked to as non-eligible for coverage or treatment. I wonder how the self-ordained and coveted plastic hollywood crowd feels about being shunned by their idol?

Posted by: Mary12345 | January 27, 2011 1:13 PM | Report abuse

The anti-socialist in me thinks this 'rare' link may just be a step in the 0bammycare plan to treat implants and anything they're linked to as non-eligible for coverage or treatment. I wonder how the self-ordained and coveted plastic hollywood crowd feels about being shunned by their idol?

Posted by: Mary12345 | January 27, 2011 1:14 PM | Report abuse

The anti-socialist in me thinks this 'rare' link may just be a step in the 0bammycare plan to treat implants and anything they're linked to as non-eligible for coverage or treatment. I wonder how the self-ordained and coveted plastic hollywood crowd feels about being shunned by their idol?

Posted by: Mary12345 | January 27, 2011 1:14 PM | Report abuse

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