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Breast Implant Dangers and the FDA

FDA Warning: Link Between ALCL Cancer and Breast Implants

In a report published in January 2011, the U.S. Food and Drug Administration (FDA) presented "preliminary FDA findings and Analyses," entitled Anaplastic Large Cell Lymphomas (ALCL) in Women with Breast Implants.

The FDA said that reports in the scientific community suggest a possible relationship between ALCL and breast implants. According to reports, the FDA says, summarizes current data and the agency's understanding of data in the scientific literature and information it gathered from other regulatory authorities, scientific experts and makers of breast implants.

The agency said it believes that while ALCL is extremely rare, women with breast implants may have a very small but increased risk of developing this disease in the scar capsule adjacent to the implant. After an implant is inserted, scar tissue usually develops around the implant as part of the natural healing process.

The FDA is saying, therefore, that it seems there is a very small but increased risk of ALCL developing in scar tissue. It is not saying that ALCL is a form of breast cancer or that breast implants cause ALCL.

The FDA said it is working with the American Society of Plastic Surgeons to set up a registry of cases of women who have breast implants and are then diagnosed with ALCL.

ALCL Breast Cancer Signs

ALCL is usually found in patients when they have revision surgery for an earlier operation (often many years earlier) done originally to insert breast implants. The revision surgery has uncovered, through cell biopsies, ALCL in the scar tissue and in fluid surrounding the implant.

The FDA advises doctors to consider the possibility of ALCL in patients who have persistent fluid around the implant long after they had the original implant surgery done. Implant patients might detect signs of ALCL if the breast tissue around the implant has swelled and is painful.

Breast Implants and ALCL Statistics

The FDA has found 34 cases of ALCL in women who have received breast implants between January 1997 and May 2010. Data on women from other sources include an additional 26 cases, bringing the total to 60.

National Cancer Institute's ALCL statistics indicate about one woman in 500,000 is diagnosed with ALCL per year. The number of women whose ALCL is diagnosed in the breast is approximately three women in 100 million.

The FDA emphasizes that in women who have implants, and develop ALCL near the implant, the ALCL is not breast cancer. That is, it is not cancer of breast tissue cells. Rather, it is cancer cells found in fluid or scar tissue surrounding the implant, meaning it is a different disease from breast cancer.

If you have breast implants and are diagnosed with ALCL, contact our breast implant lawyers for legal help. You might be eligible to seek financial compensation for your injuries.

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