Update: Stronger guidance about breast implant safety

Contents

UPDATE AT A GLANCE

What is this update about?

The FDA released new guidance on saline and silicone breast implant labeling, patient communication and informed consent on October 27, 2021. The updated guidelines recommend that implant manufacturers incorporate what’s known as a “black box warning” and a decision checklist into information brochures given to patients. It also provides updated implant rupture screening recommendations.

Why is this update important?

Many people have breast implants for reconstruction or cosmetically to alter breast size. This FDA boxed warning is intended to ensure that all people with breast implants have the appropriate information to understand and make decisions about their healthcare.

Update in brief

Boxed Warning
An FDA “boxed warning” (also called a “black box warning”) alerts people to serious or life-threatening risks from a drug or device. The FDA is requiring that a boxed warning be included as part of physician and patient materials for breast implants. The agency believes that this warning will be useful in communicating identified breast implant risks. The boxed warning will inform patients that:

• breast implants are not considered lifetime devices and may require replacement;
• the chance of complications increases over time;
• some complications require more surgery;
• textured breast implants have been associated with the development of a rare cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL);
• breast implants have been associated with a variety of symptoms in some women (known as breast implant illness or BII). See our XRAY review of this issue for more information.

Patient Decision Checklist
The FDA now requires implant manufacturers to include a patient decision checklist that highlights key information regarding the potential risks of having breast implants. This added information is to appear at the end of the information booklet/brochure that should be given to everyone who is considering breast implants. Surgeons must review this checklist with their patients to help ensure that they understand the risks, benefits and other information about breast implants. The patient must be given the opportunity to initial and sign the patient decision checklist, which must also be signed by the physician implanting the device.

The checklist covers:

• situations in which breast implants should not be used; 
• considerations for successful breast implant candidates; 
• the risks of undergoing breast implant surgery;
• the importance of appropriate physician education, training and experience; 
• the risk of BIA-ALCL; 
• the risk of systemic symptoms;
• discussion of options other than breast implants, as appropriate.

Rupture Screening Recommendations
The FDA is also updating its rupture screening guidelines for silicone gel-filled breast implants:

"It is recommended that you have periodic imaging (e.g., MRI, ultrasound) of your silicone gel-filled breast implants to screen for implant rupture regardless of whether your implants are for cosmetic augmentation or reconstruction. These recommendations do not replace other additional imaging that may be required depending on your medical history or circumstances. Even if you have no symptoms, you should have your first ultrasound or MRI at 5-6 years after your initial implant surgery and then every 2-3 years thereafter. If you have symptoms at any time or uncertain ultrasound results for breast implant rupture, an MRI is recommended."

Previous FDA guidelines recommended screening silicone breast implants for a rupture with a breast MRI 3 years after the initial implant surgery and every 2 years after that. The new guidelines reflect research indicating that ruptures are more likely to occur 6 years after silicone devices are implanted. Breast ultrasound is a less costly alternative to breast MRIs.

Patient Device Card
Patient device cards provide patients with unique information about their breast implants. Patients should receive this card immediately following surgery. The device card should include the following information:

• the serial or lot number of the device;
• the style and size of the device;
• the Unique Device Identifier (UDI);
• a web link to access the most current patient decision checklist, the box warning and labeling for the specific implant received by the patient;
• a statement that “There is a boxed warning for breast implants, see web link”;
• a toll-free phone number to contact the breast implant manufacturer.

What does this mean for me?

If you get breast implants in the future, you should receive a Patient Device Card that provides specific information about your implants immediately after surgery. If you already have breast implants and do not know which type of implant you have, you may want to request this information from the physician who performed your implant surgery.

If you already have breast implants, it is important to know that they are not lifetime devices, and at some point, you may need to have them removed or replaced. The FDA recommends regular imaging (e.g., MRI, ultrasound) of your silicone gel-filled breast implants to monitor for implant rupture. (Imaging of saline implants for rupture isn’t required). Even if you have no symptoms, you should have your first ultrasound or MRI at 5-6 years after your initial implant surgery and then every 2-3 years thereafter. If you have symptoms at any time or uncertain ultrasound results for breast implant rupture, an MRI is recommended.

Complications, although rare, may arise long after your initial surgery. Textured implants are linked to a rare type of lymphoma called BIA-ALCL. Some people with breast implants have experienced systemic symptoms known collectively as breast implant illness or BII.

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posted 12/14/21

Reference

Federal Drug Administration, Breast Implants: FDA Strengthens Breast Implant Safety Requirements and Updates Study Results. Published online October 27, 2021.

Disclosure

FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.