> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Cautions on Breast Implant Risks
- URL: https://www.fdaweb.com/fda-cautions-on-breast-implant-risks/
- Published: 2019-02-07T12:00:00.000Z
- Updated: 2026-09-15T01:01:18.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143318

FDA says it is working to raise awareness of the association between all breast implants, regardless of filling or texture, and breast implant associated-anaplastic large cell lymphoma (BIA-ALCL). An agency [letter](https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm630863.htm?ref=fdaweb.com) to healthcare providers says FDA has received reports indicating that patients with breast implants have an increased risk of developing this disease within the scar capsule adjacent to the implant.

“We want all healthcare providers to be aware of BIA-ALCL, particularly in patients with new swelling, lumps, or pain around breast implants, to expedite diagnosis of this malignancy,” the letter says. “We are also asking healthcare providers to report to FDA cases of BIA-ALCL in patients with breast implants. This includes reporting individual cases as well as rates you may have experienced during your practice.”

FDA says it has reviewed 660 medical device reports of BIA-ALCL and has identified 457 unique reports, including nine deaths that may be attributable to BIA-ALCL. “Though the number of identified cases of BIA-ALCL is small compared to the estimated 1.5 million patients who receive breast implants worldwide every year,” FDA says, “confirmed data and published information reviewed to date suggests that patients with breast implants have an increased risk of BIA-ALCL.”

The letter includes steps the agency recommends that healthcare providers implement.

In a related [statement](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm630895.htm?ref=fdaweb.com), CDRH Division of Surgical Devices director **Binita Ashar** says FDA hopes the BIA-ALCL letter prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-ALCL. “At the same time,” she writes, “we remain committed to working in partnership with all stakeholders to continue to study, understand, and provide updates about this important public health issue.”

Ashar says FDA recognizes that its counterparts in different countries are taking certain actions or may be reporting different information about breast implant safety than FDA. “The different devices approved in each country, availability of products, variation in market share, extent of medical device adverse event reporting, and availability of information regarding the total number of implants sold differs from country to country,” she says. “This makes it difficult for the regulatory bodies of different countries to compare data and determine risk rates on a global scale.”