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The FDA Reveals Association between Breast Implants and Rare Form of Cancer (ALCL)

February 04, 2011

The FDA revealed a possible association between saline and silicone gel-filled breast implants and anaplastic large cell lymphoma (ALCL), an extremely rare type of cancer. Based on data analyzed by the FDA, the agency revealed that women with breast implants might have a very small but significant risk of ALCL in the scar capsule adjacent to the implant. Doctors are being asked to report incidents of ALCL that appear in the breast of patients with breast implants.

ALCL is extremely rare and normally only manifests itself in the breast of women who have breast implants at a rate of 3 in 100 million.

The FDA indicated that there have been 60 cases of ALCL in women with breast implants. The FDA also warned that the number might be inaccurate because the scientific literature does not contain all the ALCL cases, and some cases may be duplicates. Estimates place the number of women with breast implants at 5-10 million worldwide.

Anaplastic large cell lymphoma is an aggressive T-cell lymphoma which is a cancer that involves cells of the immune system. The cases of ALCL related to breast implants are not a cancer of the breast tissue, but a cancer in the fibrous scar tissue that develops around the breast implant after surgery. Most cases of ALCL that have been diagnosed in women with breast implants were discovered after women sought medical evaluation reporting pain, lumps, swelling or asymmetry of their breasts.

The FDA did indicate that the likelihood of women with breast implants developing ALCL is small, but the FDA is requiring that breast implant manufacturers update their product labeling materials to warn the public and doctors of the risk. The FDA is also recommending that women with breast implants monitor their breasts and contact their doctor promptly if they notice pain, swelling or any changes in or around their breast implants.

If you are diagnosed with ALCL in the breast area and have breast implants, you should contact Montlick and Associates, Attorneys at Law, for a free initial case evaluation. Our experienced Georgia defective medical device attorneys are available to assist clients throughout all of Georgia and the Southeast, including but not limited to Albany, Athens, Atlanta, Augusta, Columbus, Gainesville, Macon, Marietta, Rome, Roswell, Savannah, Smyrna, Valdosta, Warner Robins and all smaller cities and rural areas in the state. No matter where you are located we are just a phone call away, and we will even come to you. Call us 24 hours a day/7 days a week for your Free Consultation at 1-800-LAW-NEED (1-800-529-6333). You can also visit us online at and use our Free Case Evaluation Form or 24 hour Live Online Chat.

Category: Personal Injury

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All information provided by our blogs is general in nature and should not be relied upon as legal advice. Consult a Montlick attorney for details about your unique situation.