A panel of advisers for the U.S. Food & Drug Administration (FDA) agreed that women should be given better information about the risks associated with breast implants, but refused to back a ban on a specific type of device that has been implicated in a rare form of cancer.
The recommendations were made without a formal vote at the end of two-day FDA hearing to address thousands of reports linking the breast to chronic fatigue, muscle pain, cognitive issues, connective tissue disorders, and other serious health problems.
Textured breast implants, in particular, are a prime suspect in anaplastic large cell lymphoma (ALCL), a type of cancer that occurs in the scar capsule that eventually forms around the devices.
During the hearing, the FDA advisers heard emotional testimony from multiple women who became sick after receiving breast implants. While some said their doctors discussed the general risks associated with any surgery prior to the procedure, they failed to address complications that could be caused by the implants themselves. Others never received the patient information brochures provided to doctors by breast implant manufacturers.
The women and their advocates asked the FDA panel to recommend a “Black Box Warning” for breast implants, as well as a requirement that patients sign a two-page checklist on implant risks before surgery. Some also argued for a ban on textured breast implants, which have already been pulled from the market in several other countries because of their potential link with ALCL.
At the conclusion of the meeting, the FDA advisers agreed that women considering breast implants should be provided with better information about possible risks and complications. In doing so, they signaled support for a standardized, easily understood consent form that would be reviewed by patients and their doctors prior to surgery.
They also agreed that the FDA should rethink its current recommendation that patients with silicone breast implants undergo an MRI for so-called “silent” ruptures at 3 years post-op and every 2 years after that.
The panel’s chairman noted that most breast implant ruptures occur 6-10 years post-op and suggested a low rate of compliance with current recommendations reflected the high costs of MRI scans. As an alternative, he suggested ultrasound screening 5-6 years post-implantation fr asymptomatic patients, and repeat screenings at 2-3 year intervals.
Most of the panelist thought it was too soon to consider a ban on textured devices, and felt that more data is needed to fully understand the mechanisms behind breast-implant associated ALCL
Breast implant-associated ALCL is slow-growing T-cell cancer. If detected in time, removing the implants and surrounding scar tissue can usually cure the disease. The FDA previously advised women with any type of breast implants to contact their doctor if they experience any signs or symptoms of ALCL, including:
At least 457 women in the United States have developed the rare cancer, and nine have died. Six hundred cases of breast implant-associated ALCL, including 17 deaths, have been reported worldwide. The majority of women received textured breast implants, which are designed to prevent slippage and minimize scar tissue. However, some did develop the disease after receiving smooth-surfaced devices implants.