Are breast implants safe? What is FDA’s Track Record?

Diana Zuckerman, PhD, Cancer Prevention & Treatment Fund

In 2013, a study showed that a rare cancer of the immune system, ALCL, which had previously been linked to saline breast implants and silicone breast implants, was caused by breast implants and could be fatal.  The latest research indicates that this cancer is sometimes cured by removing the breast implants, but at other times also requires radiation and chemotherapy; in some cases, the patients died despite treatment. Although the FDA had reported in 2011 that ALCL might be caused by breast implants, the agency didn’t update its website when the 2013 study was published.  It took the FDA more than 3 more years to revise articles on its website indicating that breast implants caused ALCL ( to conclude that breast implants could cause ALCL. The FDA reported that they have received 359 reports of ALCL among women with breast implants through February 2017. It’s likely there are still numerous unreported cases; for example, Australia’s medical agency estimates that one in 1,000women with breast implants develops ALCL.  There is no reason to think American women would be less likely to develop ALCL, and that would result in several thousand U.S. women developing ALCL

This is just the latest bad news for women with breast implants, and for the government agencies that have allowed them on the market with inadequate studies or warnings.  For example, in 2011, tens of thousands of defective breast implants made by PIP were recalled in Europe. An article in the December 2012 issue of the British medical journal Reproductive Health Matters explains how these developments illustrate the strengths and weaknesses of the safeguards intended to protect patients in different countries from unsafe breast implants and other medical devices.  In the U.S., breast implants are regulated as high-risk medical devices that must be proven reasonably safe and effective in clinical trials and subject to government inspection before they can be sold. This standard is higher than the FDA requires for hip joints, numerous cardiac devices, and many other medical implants. In contrast, clinical trials and inspections have not been required for breast implants or other implanted devices in Europe. As a result of these differing standards, the PIP breast implants that were recalled across Europe had already been removed from the U.S. market years earlier. The FDA was justifiably proud that they had done a better job of protecting breast cancer patients and cosmetic augmentation patients than the EU regulatory system. Nevertheless, the FDA track record on breast implants shows how limited those safeguards can be. The FDA required two breast implant companies to conduct enormous 10-year studies of breast implants, but has done little to ensure that the studies are providing useful information to patients.

The authors conclude that neither the European Union nor the U.S. has used their regulatory authority to ensure the long-term safety of breast implants. However, in 2012 the EU announced regulatory changes that could improve that situation. In addition, the CEO of PIP was sentenced to 4 years in prison by a French Court, and in January 2017, a French court demanded that the German regulatory company that had certified PIP implants as safe pay $60 million euros to women harmed by PIP implants. This is only 3,000 euros each to 20,000 women, however.

Meanwhile, the FDA shows no indication that they will improve their safeguards on breast implants or other medical implants; in fact, those safeguards have weakened since 2012.

For more information about ALCL caused by breast implants, see:

Miranda RN, Aladily TN, Prince HM, et al: Breast implant–associated anaplastic large-cell lymphoma: Long-term follow-up of 60 patients. J Clin Oncol 32:114-120, 2014.

Mazzucco, AE.  Next Steps for Breast Implant-Associated Anaplastic Large-Cell Lymphoma. J Clin Oncol, 2014.  Early Release publication. June 16, 2014.