Association of Breast Implants and Rare Cancer

FDA asks health care pros, patients to help collate data

The risk of surgery is a factor to consider when undergoing any procedure, but more so when considering cosmetic surgery. 

Will it be worth it?  What if something happens? 

A recent review by the U.S. Food and Drug Administration (FDA) is throwing another concern into the mix of things.  According to the administration, there is a possible association between saline and silicone gel-filled breast implants with a rare type of cancer, anaplastic large cell lymphoma (ALCL). 

The statement details that those with implants may be at risk of cancer developing in the scar capsule near the implant.  To provide clear, up-to-date information to patients, the FDA is currently working with health care professionals and implant manufacturers to update the potential, related risks of the procedure.

“We need more data and are asking that health care professionals tell us about any confirmed cases they identify,” said William Maisel, M.D., M.P.H., chief scientist and deputy director for science in FDA’s Center for Devices and Radiological Health in the release. “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.”

For Kristen, a nutritionist, publicly announced information such as this was helpful in swaying her recent decision to decline having implants.

“I was considering implants to look more womanly.  I have always been flat-chested and wanted to look more voluptuous,” she said, “but the risks are not worth it and information like this is helpful.”

Like with any cosmetic and surgery procedure, women should thoroughly weigh the pros and cons of breast implants. 

“In order to stay well-informed on their health care, women considering breast implant surgery -- or any medical decision -- should always discuss the potential risks and benefits of the procedure with a doctor,” advised Dr. Maisel.  “It's very important to be aware of risks and benefits before undergoing a medical procedure.”

Dr. Maisel adds that the FDA will continue to keep the public informed of risks of silicone breast implants.  In the spring, the agency will release updated findings from post-approval studies for silicone breast implants sold within the U.S., combined with reports detailing adverse side effects.

Irregular symptoms from implants include lumps as well as prolonged and severe pain.  If you have recently had implants and have been experiencing any of these problems or have noticed any changes in the breast region, schedule an immediate appointment with your doctor. 

Additionally, physicians are being urged by the FDA to report any symptom irregularities to its MedWatch affiliation in the effort to collate implant data.

“Additional data is needed to fully understand the possible relationship between ALCL and breast implants. The FDA needs to collect and review additional information from health care professionals and women with confirmed reports of ALCL who had or currently have breast implants before making further recommendations regarding potential risks, treatment options and prognosis,” said Dr. Maisel.                                            

Kristen urges women, like herself, who are considering implants to do their research, since the decision stands as a significant, personal one.  Even though she herself opted out of the procedure, millions of Americans across the country have breast implants. 

“At the end of the day, it’s important to be informed,” concluded Kristen, “and to know all answers before making a permanent, life-changing decision.”

To report confirmed cases of ALCL, contact MedWatch by calling 800-332-1088 or by visiting http://www.fda.gov/Safety/MedWatch/default.htm.

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