FDA Issues Strongest Possible Warning for All Breast Implants
In March 2019, dozens of women appeared before a U.S. Food and Drug Administration (FDA) advisory panel to give their accounts of how breast implants had caused them to suffer illness. Eighteen months later, on September 28, 2020, the FDA issued its strongest warning for all breast...
Allergan Begins Campaign to Track Breast Implant Patients to Warn of Cancer Risk
Allergan wants
to track breast implants—and they have a really good reason.Responding to a
request from the U.S. Food and Drug Administration, Allergan Aesthetics, an
AbbVie company, issued a recall of its BIOCELL breast implants and tissue
expanders in the summer of 2019. Studies have linked...
Surgeon Sheds Light on Breast-Implant-Associated Lymphoma
The U.S. Food and Drug Administration (FDA) sounded
the alarm on July 6, 2019. The agency had received 573
medical device reports (MDRs) of breast implant-associated anaplastic large
cell lymphoma (BIA-ALCL).Although the FDA first identified a link
between ALCL and breast implants in 2011, a lack...
FDA Recommends Black Box Warning on Breast Implants
This month, the FDA published
recommendations that a “black box” warning be added to package labels for
saline and silicone breast implants. At this point, the recommendations are in
the form of “draft guidance” and are still subject to public review and
comments before they are finalized. This is a significant...
What is Anaplastic Large Cell Lymphoma (and What Does it Have to Do With Breast Implants)?
Non-Hodgkins lymphoma (NHL) has
been in the news a great deal lately because of its link to the herbicide Roundup. Anaplastic Large Cell
Lymphoma (ALCL) is a rare variant of the same disease that most often affects children
and young adult males. However, in recent years, medical researchers have
discovered links...