by Karuna Jaggar, Executive Director
We have an important opportunity right now to ensure that everyone considering breast implants has complete and balanced information about the risks and potential harms.The Food and Drug Administration (FDA) is updating their labeling recommendations for breast implants and adding new informed consent procedures and they want to hear from you!
The FDA is updating their Guidance on Breast Implants from 2006, and our staff has already helped inform the FDA’s new draft language through our work on two interdisciplinary breast implant working groups.
Now we’re asking you to join us and urge the FDA to strengthen their draft guidance, which needs to be mandatory.
It’s estimated that more than 100,000 breast cancer patients choose reconstruction with breast implants after mastectomy each year. And hundreds of thousands of additional breast implants are used each year for breast augmentation and gender transition. The FDA’s new draft guidance should require that everyone considering implants be informed about the risks and potential harms.
For too long, manufacturers have failed to collect important safety information, and surgeons have downplayed the risks of breast implants. Most people are surprised to learn that breast implants have never been proven to be safe. A combination of regulatory loopholes and lax action on the part of the FDA has meant that for more than fifty years, breast implants have been surgically put into the bodies of women without long-term safety studies.
As early as the 1970s women were reporting a range of harms and health issues, including what is now called Breast Implant Illness (BII), disfigurement, disability, and other health problems. In 2011 the FDA acknowledged the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare but serious cancer of the immune system. Earlier this year, the FDA issued a Class 1 recall of one company’s textured implant products because of the increased risk of BIA-ALCL.
But the problem with breast implants is bigger than one company’s products. We believe that everyone considering implants needs to be warned of the risks and potential harms, which should not minimize the severity of or number of women reporting Breast Implant Illness. The fact remains that we lack adequate safety data about breast implants, even though they’ve been on the market for more than fifty years. Independent, long-term safety studies of breast implants are essential and remain an urgent priority.
Right now we have an important opportunity to ensure that everyone considering breast implants has information about the risks and potential harms.
Thank you for speaking out!