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 At this point, the recommendations are in the form of “draft guidance” and are still subject to public review and comments before they are finalized.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 step, however, as a boxed warning is the most serious level. It is required for medical devices that are implanted into a patient’s body and present a risk of serious injury, illness, or death.
Among the information that would be included in such a warning:
- “breast implants are not considered lifetime devices”. One in five women who have breast augmentation procedures wind up having them removed after 8 to 10 years due to complications, which can manifest as breast pain, scar tissue buildup around the implant, rupture, and leakage.
- “breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma”. This applies specifically to textured breast implants made by Allergan, which has caused women to develop the condition.
- the requirement of a “decision checklist” for patients to go over with their physicians.
- recommendations for patient screening for rupture and leakage.
These recommendations come in the wake of testimony at a public advisory meeting this past March, during which women who had undergone breast augmentation spoke of the various complications they had suffered. There was also concern expressed that full disclosure has not been made to women who are considering such surgery. Despite this, breast augmentation remains the most popular type of plastic surgery.
The Allergan Biocell textured breast implants have a surface similar to sandpaper, which is supposed to cause irritation to the inner surface of the “pocket” that holds the implant, building up scar tissue that holds the device in place. This process appears to cause chronic inflammation, which leads to the condition that doctors have identified as “Breast Implant Associated Anaplastic Large Cell Lymphoma,” or BIA-ALCL. These types of breast implants are rarely used in the U.S. and account for under 5 percent of all such devices sold on the domestic market. Nonetheless, Allergan issued a global recall for the implants this past summer.
The public comment period for the draft guidance recommendations ends on December 23, 2019. Once it is finalized, manufacturers have the option of labeling their products in any manner they choose, provided the labeling follows FDA regulations.