by Reichman University

Credit: Unsplash/CC0 Public Domain

A new Reichman University study examines how conflicting interpretations regarding breast implants risk the erosion of the reputation of the US Food and Drug Administration (FDA). The FDA frequently finds itself embroiled in public debates about the severity of side effects associated with drugs or medical devices it has approved.

These debates typically generate differing viewpoints among the medical community, patients, and the general public, with some arguing that very serious side effects warrant significant regulatory intervention and others maintaining that such intervention is unnecessary.

An article by Prof. Moshe Maor of the Lauder School of Government, Diplomacy and Strategy at Reichman University and Prof. Yehuda Shoenfeld of Sheba Medical Center and the Dina Recanati School of Medicine at Reichman University seeks to address this issue by focusing on silicone breast implants.

The article is published in the journal Frontiers in Medicine.

These implants were selected for the study due to their turbulent regulatory history, which has included a marketing ban, marketing approval, and warnings from the US Food and Drug Administration.

One such warning was issued with regards to the implantation of textured breast implants that may cause a type of lymphoma known as BIA-ALCL, an acronym for Breast Implant-Associated Anaplastic Large Cell Lymphoma.

To provide answers to questions about the severity of side effects linked with silicone implants, the FDA relies on mechanisms for collecting data on these side effects that are activated only after marketing approval is given to the implants.

The article examined all of these mechanisms and found that they are calibrated to collect low-quality information. For example, the FDA's requirement for post-marketing medical-scientific reporting of implant-related studies is not consistently enforced.

This limited enforcement makes it difficult for surgeons and patients to make informed decisions, particularly when it comes to identifying and treating rare and aggressive tumors associated with silicone implants.

This problem is exacerbated by underreporting, double reporting, and a lack of transparency. For instance, in 2019, the FDA revealed that it had received over 300,000 reports of adverse events related to breast implants—more than 20 times the number previously reported to the public.

Prof. Yehuda Shoenfeld explains, "To improve oversight, several initiatives have been introduced in the US, such as the National Breast Implant Registry, which was created in collaboration with the FDA and tracks cases of implant-related lymphoma. However, participation in the registry is voluntary and does not include non-specialist surgeons, which contributes to delays in regulatory intervention.

"While patients can rely on the FDA's Black Box Warning, which went into effect in 2021, this warning does not include information about the risk of squamous cell carcinoma. Additionally, inconsistencies in the standardization of the informed consent process between doctors and patients undermine reliable reporting of side effects.

"Similarly, initiatives such as the National Evaluation System for Health Technology (NEST) are designed to improve data collection, but participation is voluntary, and its data is based primarily on health care claims data rather than clinical outcomes."

Conflicting interpretations of the severity of side effects place the FDA in a challenging position, caught between the interests of the medical industry—which funds a significant portion of its budget—and its legally mandated role to safeguard public health.

"Because the FDA cannot rely solely on congressional appropriations to ensure a steady stream of funding, the confusion and uncertainty created by these conflicting interpretations increases its ability to to maneuver between different target audiences, and thus maintain the support of the industry, patients, and the public," explains Prof. Moshe Maor.

"If there was a consensus among the medical community, patients, and the general public regarding the necessity for immediate regulatory intervention, the FDA's room for maneuver would be limited. Reputational incentives encourage the FDA to continue this strategy as long as the possibility of receiving funding from the pharmaceutical industry remains.

"Such a strategy usually persists until critical information about side effects emerges, presenting a genuine risk to the FDA's reputation and professional credibility."

The researchers call for the establishment of a stable, appropriation-based funding model that may change the FDA's reputational incentives and lead to strengthened post-marketing surveillance of drugs and medical devices.

More information: Moshe Maor et al, Conflicting interpretations and FDA reputation: the case of post-market surveillance of breast implants, Frontiers in Medicine (2024). DOI: 10.3389/fmed.2024.1475992

Provided by Reichman University