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WASHINGTON -- The FDA issued a recommending that manufacturers of breast implants include a boxed warning that clearly spells out the risks of their products.

The agency also called on implant-makers to include a patient decision checklist and list the devices' ingredients, and updated its own recommendations for implant rupture screening.

In a on Wednesday, FDA Principal Deputy Commissioner Amy Abernathy, MD, PhD, and Jeff Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health, said they got the message "loud and clear" that the regulatory body needs to do a better job protecting women considering breast implants -- both from an advisory committee meeting held in March and other information-gathering efforts.

"We have heard from many women that they are not fully informed of the risks when considering breast implants," they said. "Many stakeholders suggested that a boxed warning and patient decision checklist could provide this information."

Suggestions for the boxed warning include the following:

• Breast implants are not considered lifetime devices

• The chance of developing complications increases over time

• Some complications require more surgery

• Implants carry the risk of breast-implant associated anaplastic large cell lymphoma (BIA-ALCL)

• Implants may be associated with systemic symptoms such as fatigue and joint pain

But the agency will still allow textured implants to stay on the market.

In July, the FDA called on Allergan to pull certain textured breast implants from the U.S. market due to the risk of BIA-ALCL. At the time, the agency said that 573 cases had been reported worldwide, with 481 linked to Allergan's products.

FDA said makers should include the patient decision checklist as part of an informational booklet or brochure to help patients determine whether they might be a poor candidate for an implant, offering multiple examples putting individuals at higher risk of complications. For example, "I understand that if I have any of the following conditions, I may be at a higher risk for a poor surgical outcome: Medical conditions that affects my body's ability to heal (e.g., diabetes, connective tissue disorder)."

In their example, they also urged patients to inquire about their "surgeon's experience, education, training and credentials."

The revised rupture screening recommendations say that asymptomatic patients with silicone gel-based implants should receive ultrasound or MRI at 5 to 6 years following an implantation, and then every other year thereafter. MRI is recommended for symptomatic patients and for those with uncertain ultrasound results for breast implant rupture.

As for the product ingredients, Abernathy and Shuren said the "FDA believes that improved access to this descriptive information will help better inform patients of the types and quantities of chemicals and heavy metals that are in breast implants."

Writing in a unrelated to the FDA's announcement, Terence Myckatyn, MD, and colleagues from the Washington University School of Medicine in St. Louis, discussed the risks of BIA-ALCL and called for a "robust informed consent process" and that physicians engage in shared decision-making with patients who seek breast implants.

"In most cases, we believe that we can achieve equivalent results with either smooth or textured-surface breast implants, and that differential outcomes resulting from choosing one device vs the other are imperceptible in most cases," they wrote. "Although the lifetime risk of BIA-ALCL is low, it is a serious risk that can be life threatening for a small subset of patients. "

BIA-ALCL typically develops 7 to 9 years after an implantation, Myckatyn's group noted. In about 80% of cases, patients present with a spontaneous seroma while approximately 20% present with a mass.

They acknowledged that certain situations might call for textured implants, however.

"Patients who require revision surgery owing to implant malposition can benefit from placement of a textured breast implant to reduce the risk of recurrent malposition," said Myckatyn and co-authors. "Armed with this information, some patients do choose to accept the risks of BIA-ALCL to improve the chances of a durable cosmetic result after revision surgery."

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