Public Health Implications of Differences in US and European Union Regulatory Policies for Breast Implants

Diana Zuckerman, PhD, Nyedra Booker, PharmD, MPH, and Sonia Nagda, MD, MPH, Reproductive Health Matters: December 2012

In 2011, the European Union recalled the Poly Implant Prothèse (PIP) silicone breast implants. In the same year, the U.S. Food and Drug Administration (FDA) announced that breast implants were associated with an increased risk of developing a rare cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). These events raised questions about whether U.S. and European Union (EU) regulations are actually protecting patients from unsafe medical implants.

Initially breast implants in the U.S. were considered moderate-risk medical devices, but in 1988 breast implants were re-classified as high-risk. In the early 1990s, lawsuits, hearings, and Congressional investigations revealed that the breast implant manufacturers had covered up evidence that silicone gel breast implants could leak and the silicone could migrate into women’s lymph nodes. In 1991, new U.S. policy required that clinical trials prove that breast implants are safe and effective. In 1993, the European Union followed the lead of the U.S. in restricting access to silicone gel breast implants as part of broader new regulations in a Medical Device Directive released by the European Commission.

Both the U.S. and the EU classify breast implants as high-risk medical devices. The U.S. has required long-term clinical trials of breast implants, but hasn’t enforced those requirements. The EU does not require new clinical trials be done on breast implants if the breast implant manufacturers can justify relying on clinical data from previous studies on similar products.

As a result, clinical study data are limited and very few studies have looked at the long-term effects of breast implants.  Both the U.S. and the EU need to use more of their regulatory authority to ensure the long-term safety of breast implants.

Read the original article here.

Since the publication of the article, the EU has adopted stronger regulatory measures on medical devices that will be enforced beginning in 2020. You can read more about the new regulations here