FDA Approves New Advice to Assist Breast Reconstruction

The primary goal of breast reconstruction surgery is to restore the size, shape and symmetry of the breasts following a mastectomy. Over the past three decades, implant breast reconstruction has evolved into a highly successful surgery with excellent aesthetic results. An integral part of this success has been the use of “tissue expanders” placed under the skin prior to surgery. These balloon-like expanders stretch the skin and muscle, creating additional space for an eventual breast implant.

In the past, most tissue expanders were saline-based, wherein doctors injected a sterile salt water solution into the device through a port. The saline expander is often used in two-stage breast reconstruction surgery; however, it has one downside: needles and frequent doctor visits to administer the injections. A new air-based soft tissue expander, marketed as The AeroForm, offers breast reconstruction patients an alternative that is potentially needle-free and less cumbersome.

AeroForm wireless expander

Unlike previous devices, the AeroForm system has a wireless hand-held controller, allowing patients to inflate the device with small amounts of carbon dioxide from a reservoir of compressed CO2 located within the expander. The controller is programed to release predetermined levels of CO2 up to three times per day.

The device is manufactured by the Palo Alto-based AirXpanders.  The hope is that AeroForm has the ability to improve the experience of mastectomy patients as they undergo breast reconstruction. Beyond improved convenience and comfort, the AeroForm also promises faster results – with average time spans running 17 days compared to 4 months of traditional saline tissue expanders.

However, not all women are candidates for two-stage breast rebuilding surgery with the AeroForm. Individuals who have trace tumors at the expansion site are not able to use the system, and patients who have pacemakers, defibrillators, or electronic devices are not eligible for the treatment.

According to Dr. Binita Ashar, a director at the FDA’s Center for Devices and Radiological Health, “Patients need to speak with their surgeons about what type of tissue expander is appropriate for them and the benefits and risks of using an expander following their mastectomy.”

Ideal candidate criteria

The majority of women undergoing unilateral or bilateral mastectomy for breast cancer are good candidates for staged breast reconstruction with tissue expanders. Good candidates include those who:

• Are unable to have a flap operation
• Have healthy tissue at the mastectomy site
• Prefer a bilateral reconstruction
• Have not received radiation on the chest wall
• Are currently at a healthy weight
• Understand the risks and benefits of tissue-expanding staged surgery

Breast reconstruction in NYC

When performed by a skilled plastic surgeon, breast reconstruction surgery helps lessen the physical and psychological effects of mastectomy. Dr. B. Aviva Preminger is a nationally-acclaimed reconstructive and plastic surgeon in New York City who is committed to helping her patients feel beautiful again. She is renowned not only for her compassionate bedside manner, but for her clinical expertise and natural results.

If you’d like to learn more about breast reconstruction in NYC with Dr. Preminger, we invite you to schedule a private consultation.