by Diana Zuckerman, PhD
In 2011, the FDA announced that saline breast implants and silicone gel breast implants were linked to a rare cancer of the immune system. A few months later, due to an unrelated scandal, 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 US 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. Meanwhile, the FDA shows no indication that they will improve their safeguards on breast implants or other medical implants.
For more information:
D Zuckerman, N Booker, and S Nagda, “Public Health Implications of Differences in US and European Union Regulatory Policies for Breast Implants,” Reproductive Health Matters, December 2012, http://www.ncbi.nlm.nih.gov/pubmed/23245415