Seattle Post-Intelligencer: January 12, 2007
We’ve never had much faith in the FDA, but its approval of silicone gel-filled breast implants marks an all-time low for the agency.
Restricted since 1992, the implants were deemed unsafe because of the health risks associated with them, such as cancer. The FDA currently recommends that only women over the age of 22 get the implants. It also asks the makers of the implants (which can rupture during a mammogram), Allergan Corp. and Mentor Corp., to carry out a 10-year, 80,000-patient study in order to “fully answer important questions” regarding the products safety. […]
We spoke to two experts on the matter: Diana Zuckerman, president of the National Research Center for Health Research at the University of Pennsylvania Center for Bioethics, and Susan Wood, a research professor at George Washington University’s School of Public Health. The two scientists want you to know a few things:
Post-approval studies are common, but the sheer scope of this one should be a red flag. Also, neither the age of breast-implant recipients nor the collection of data by the two companies can be enforced.
Although you can pay for the implants in installments, you can’t do so for their removal — and they will need to be removed or replaced. Health insurance seldom covers those additional surgeries.
You’ll need to get pricey MRIs regularly. And no, your insurance probably won’t cover them.
By no means should you take the FDA’s approval of the implants to mean that they’re safe. For example, their effect on breast milk, says Zuckerman, has “never, ever, ever been tested” by the FDA. […]
Read the original article here.