THE OUTLOOK FOR HEALTH CARE IN 2023:

What you need to know about the forces reshaping our industry.

X

September 12, 2022

Around the nation: FDA issues warning about potential link between breast implants and certain cancers

Daily Briefing

    FDA on Thursday warned that certain types of cancer may develop in the scar tissue that forms around breast implants, in today's bite-sized hospital and health industry news from the District of Columbia and Maryland.

    • District of Columbia: The Department of Homeland Security (DHS) on Thursday issued a rule that reverses a policy from the Trump administration rule that deterred non-citizen immigrants from using government-funded health services. According to Drishti Pillai, director of immigrant health policy at the Kaiser Family Foundation, the rule "likely instilled a lot of fear in immigrants to apply for these benefits not only for themselves but also for family members who may have been citizens due to fear of exposing their documentation statuses." Under the new rule, DHS said it will not classify non-citizens as "public charges," which could prevent them from obtaining green cards if they use government-funded health services. "People who qualify for Medicaid, CHIP, and other health programs should receive the care they need without fear of jeopardizing their immigration status," said HHS Secretary Xavier Becerra. "As we have experienced with Covid, it's in the interest of all Americans when we utilize the health care and other services at our disposal to improve public health for everyone." (Dreher, Axios, 9/9; Trang, STAT, 9/8)
    • Maryland: FDA on Thursday warned that certain types of cancer may develop in the scar tissue that forms around all types of breast implants, including textured and smooth implants, and implants filled with silicone or saline. Previously, the agency confirmed the link between Allergan's textured implants and anaplastic large cell lymphoma (ALCL). FDA's latest warning included documented cases of squamous cell carcinoma and other types of lymphoma that were found in the scar tissue around breast implants. While the cases are rare—with less than 30 known cases of lymphomas and less than 20 known cases of carcinoma—FDA noted that "health care providers and people who have or are considering breast implants should be aware that cases have been reported to the F.D.A. and in the literature." According to FDA spokesperson Audra Harrison, the new cancers were an "emerging safety signal that we're seeing with implants that we will be communicating about, separate from ALCL." (Rabin, New York Times, 9/8)
    • Maryland: CMS has extended the deadline to comment on its proposed rule for Clinical Laboratory Improvement Amendment (CLIA)-certified labs to Sept. 26. The American Hospital Association (AHA) last month submitted comments cautioning CMS against relaxing standards set to uphold the quality and safety of laboratory testing. In addition, AHA voiced support for a different proposal that would make Covid-19 waivers that strengthened CMS' ability to implement sanctions for non-compliance permanent. (AHA News, 8/25)

    Have a Question?

    x

    Ask our experts a question on any topic in health care by visiting our member portal, AskAdvisory.