Statement on Behalf of Members of the Patient, Consumer, and Public Health Coalition at the FDA Advisory Committee on Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and Informed Consent

Varuna Srinivasan, MBBS, MPH, National Center for Health Research

I am Dr. Varuna Srinivasan, a physician with an MPH from Johns Hopkins, speaking on behalf of members of the Patient, Consumer, and Public Health Coalition, a group of nonprofit organizations representing millions of Americans.  We have no conflicts of interest.

FDA has been slow to recognize the full impact of BIA-ACL and needs to do more to protect women from it.

Dutch scientists first reported the association between breast implants and ALCL in 2008, but patients didn’t hear about it. It was another 3 years before FDA and the media first acknowledged the possible association between breast implants and ALCL.

The link was strengthened in 2013 with the MD Anderson Cancer Center study of 60 women with BIA-ALCL.   The next year, the NCCN released a worldwide oncology standard for physicians to test and diagnose BIA-ALCL. In 2016, the World Health Organization added BIA-ALCL to its classification of lymphoid neoplasms.

The FDA website did not acknowledge that implants sometimes cause ALCL until 2017. Before that, the vast majority of women considering breast implants were not informed about the risk of ALCL from implants, especially textured implants.

We now know that BIA-ALCL is more common than first believed.  Australia’s superior surveillance system has estimated it as high as 1 in 1,000 women with breast implants.

The delayed intervention of the FDA and surgeons everywhere on this matter is too serious to ignore.  For those women who were barely informed of these severe risks, it has had terrible and sometimes fatal consequences.

What should FDA do to help protect women from ALCL?

#1 Research indicates that at least some textured implants should be banned because they are most likely to cause ALCL.  FDA should conduct or require research to determine if the benefits outweigh the risks for any textured implants.

#2. FDA should require training for physicians and informed consent studies with breast implant patients to evaluate its success in explaining the risks. As a condition of approval, FDA should mandate that a 2-page checklist explain all the local complications, adverse outcomes, and frequently reported symptoms associated with implants in an unbiased manner at least a week before surgery. This checklist should be written by ALCL patients, researchers, and plastic surgeons. Doctors should also monitor their patients regularly for signs of ALCL.

#3 The ASPS registry should include UDI numbers, and to maximize useful information the FDA should require UDIs be printed on breast implants. In addition to reoperations and ALCL, the registry should also include information about other adverse events provided by patients, oncologists, and other physicians.

Cancer patients and augmentation patients deserve to know the risks of breast implants, the and FDA needs to ensure that happens.

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