FDA Survey to Determine How Women Weigh Breast Implant Cancer Risks

The survey was designed and sent out after an Allergan textured breast implant recall due to the risk of breast implant associated ALCL

The results of a new survey will be published in the coming months which describes how well women understand and weigh the risks of developing cancer from breast implants, according to federal medical regulators.

In 2021, the FDA began requiring manufacturers of breast implants to provide a black box warning to alert patients to the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which is a rare form of lymphoma found to develop in tissue surrounding certain types of implants; primarily those with a textured surface.

Concerns about BIA-ALCL have been raised in thousands of breast implant cancer lawsuits filed against Allergan and other manufacturers, alleging the companies knew or should have known that certain macrotextured implants can cause cancer, but withheld warnings and information from women and the medical community.

In 2020, the FDA announced its Center for Devices and Radiological Health (CDRH) partnered with the independent nonprofit research group Research Triangle Institute (RTI) International to survey how patients assess cancer risks associated with smooth and textured breast implants.

According to a recent FDA update, the survey has been conducted and the CDRH is working to publish the results of this study in a peer-reviewed publication.

The FDA launched the initiative after recognizing the rate of ALCL cancer diagnoses associated with breast implants has increased in recent years, especially among those receiving textured implants.

The survey was designed to focus on questioning groups of patients considering, or those who have already had, breast reconstruction or augmentation using breast implants, as well as input from health care providers.

Officials said the study is to “assess whether patients’ perception of risks of BIA-ALCL associated with textured breast implants are influenced by information about potential benefits of textured breast implants” and “The insights gained through this patient-centered approach will help incorporate patient preferences in CDRH’s regulatory decision-making.”

Breast Implant Associated ALCL Risk

BIA-ALCL is a rare form of non-Hodgkins lymphoma that typically causes symptoms of persistent swelling and pain in the area of the implant, and is often treated by removing the breast implants and surrounding scar tissue.

Concerns and cases of BIA-ALCL  linked to textured breast implants have resulted in a growing number of breast implant lawsuits filed on behalf of women who say they were never warned about the potential risk.

An Allergan breast implant recall was issued for its textured Biocell implants in 2019, after the FDA determined the design was linked to nearly all cases of BIA-ALCL. Since then, doctors have determined removing the implants is the best means of treating BIA-ALCL in most cases, but the manufacturer continues to refuse to pay for women to have the recalled breast implants removed.

Since the recall, there has been a sharp rise in the number of lawsuits filed against Allergan over the breast implants, each raising similar allegations that the textured design was unreasonably dangerous and defective.

By 2020, at least 733 cases of ALCL had been identified worldwide among women who received breast implants, with at least 620 of the cases linked specifically to Allergan implants, according to the FDA.