The Food and Drug Administration (FDA) announced last week a series of steps meant to address long-standing concerns about breast implants. These include new labeling with a boxed warning about risks, a patient decision checklist and updated silicone gel-filled breast implant rupture screening recommendations.
These actions follow years of efforts by patient advocates and journalists to make public information about risks associated with breast implants, including a rare form of cancer of the immune system.
Laurie McGinley of the Washington Post offered a broad overview of the issue in her 2019 story about an earlier step the FDA took that helped pave the way for last week’s announcement. The FDA in 2019 issued a draft guidance document that offered recommendations for makers of breast implants about addressing potential risks. In 2020, the FDA issued a final version of this guidance document, a tool the FDA often uses to tell companies what it expects of them in terms of manufacturing, testing and promoting their products.
Last week, the FDA leveraged its authority over the regulation of medical devices to ensure that doctors discuss risks associated with breast implants with patients seeking them.
On Oct. 27, the FDA sent letters to the companies that sell breast implants in the United States, alerting them that approval of their products now rested on honoring a new limit on sales. In these letters to Ideal Implant, Mentor, Allergan, and Sientra, the FDA said sales of breast implants are “restricted to users and/or user facilities that provide information to patients about the risks and benefits of this device prior to its use in the form and manner specified in approved labeling.” These letters to companies then detail the FDA’s expectations for communication about the risks of breast implants. They are worth reading if you are covering this issue. (You can click on the links above to find them.)
Among the new requirements the FDA intends to place on sales of breast implants, physicians must review a “patient-decision checklist” with each patient, making sure they understand the risks of implants. The question remains, though, how well this mandate will be carried out in practice.
Simple language
The FDA has emphasized the need for patients to be aware of particular risks of breast implants, including the need for additional surgeries, a cancer of the immune system known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), scar tissues that can squeeze the implant (capsular contracture), breast pain, rupture, infection and deflation.
The FDA often weaves a fair amount of jargon into its documents and even some public statements. But the agency is using notably simple and clear language to address the potential harmful risks of breast implants.
“In recent years, the FDA has sought more ways to increase patients’ access to clear and understandable information about the benefits and risks of breast implants,” Binita Ashar, M.D., director of the FDA’s Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health, said in a statement. “By strengthening the safety requirements for manufacturers, the FDA is working to close information gaps for anyone who may be considering breast implant surgery.”
“Breast implants are not lifetime devices,” reads a bolded subhead on the FDA’s “What to Know About Breast Implants” website.
“The longer you have breast implants, the greater the chances are that you will develop complications, some of which will require more surgery,” the FDA adds.
How to cover this story
Journalists may find good stories by looking at how well local doctors and hospitals carry out a new mandate for improving the consent process for these implants.
It may be worth asking doctors and hospitals about whether and how the FDA mandate will change their approach to informing patients about the risks of breast implants. It also may be interesting to see how the people who have been watching this issue for many years view the FDA’s latest steps.
In a 2019 comment on the draft guidance, for example, Jane L. Delgado, Ph.D., chief executive officer of the National Alliance for Hispanic Health, urged the FDA to try to get doctors to tell patients during the first consultation about risks of implants, “rather than at the end of the process or right before surgery when changing course would be more difficult.”
I found Delgado’s letter by looking through the comments submitted on that draft guidance document the FDA released in 2019, which helped set the stage for the new mandates on makers of breast implants.
The comments submitted on this guidance document on breast implants serve as a good place to find experts on this issue.
You can also search to see if people from your community have reported to the FDA their own experience with breast implants (See image above). To do this, click on this link to go to the comments submitted on the guidance document and use the search tool to look for people from your state. Or you can choose other keywords to look for sources.
