I’m so pleased to tell you that we have a great champion in United States Senator Barbara Boxer of California, who late last week introduced a bill (S.3020) to bring greater accountability and transparency to the FDA’s regulation of silicone breast implants and all medical devices.

When the FDA approved the use of silicone implants in 2006, it failed to live up to its mandate of ensuring that the product was safe before allowing it to go on the market. Instead, the FDA decided to allow manufactures to conduct post-approval studies to demonstrate the safety of the implants once they were implanted. However, in a matter of a few months, the manufacturers convinced FDA to change the requirements of the studies, without any public input. And we learned that the FDA was essentially a “toothless tiger” when it came to going after medical device manufacturers who drag their feet or fail to submit data from their studies. Mary and I set out to correct these injustices by approaching Congress with our findings and Senator Boxer responded.

S.3020 prevents FDA from unilaterally and secretly waiving or altering a post-approval agreement with a manufacturer, without letting the public know. The bill also gives FDA greater authority to force manufacturers to comply with their post-marketing agreements, by increasing fines and requiring public notification that could lead to the removal of the product from the market.

Please send Senator Boxer a note of thanks for introducing this vital and necessary legislation. The medical device manufacturers are a $75 billion industry with a lot of influence in Washington, D.C., so it’s very important that Senator Boxer know we support her.

The easiest and most effective way is to visit her website and simply fill in the email form. Under the heading of “message topic” choose “Women’s issues” and under the heading of “Message Subject” type in “S.3020 FDA Accountability and Transparency Act.”

In the message box, please thank the Senator for introducing the bill. Her bill is vital to making sure FDA and the public receive all information necessary to make an informed decision about whether or not medical devices are safe. And let her know that FDA needs more enforcement authority to punish device makers who delay or fail to disclose information.

Please alert your networks, family and friends. Encourage them to express their support for the bill and to thank Senator Boxer.

Mary and I will be in Washington, D.C. next month and we’d love to hear the Senator tell us about all the emails she received from in support of the bill!