- FDA has no plans to ban any models of breast implants from the U.S. market at this time, regulators announced Thursday. The agency outlined its path forward on the devices, which were the subject of a recent FDA advisory panel discussion and the target of market removals in Canada, France and other countries over safety concerns.
- The agency also said it has ended all summary reporting of adverse events by breast implant manufacturers — reports which were often hidden from the public — and instead will require companies to file publicly searchable adverse events reports. The move is part of a broader effort to end alternative summary reporting for medical devices, something FDA said it plans to complete in the coming weeks.
- FDA said it would work with patient groups and other stakeholders on the content and format of a possible boxed warning or patient checklist for breast implants but it stopped short of promising changes to breast implant product labeling.
Thursday's statement gave the first glimpse into FDA's plans for the controversial devices since an advisory committee meeting in late March. And the agency's strategy on breast implants differs from regulatory approaches taken in countries like Canada and France, which recently have moved to suspend the marketing of certain textured implants linked to a type of cancer.
"The information we’ve garnered, from this meeting and other ongoing efforts, makes clear there is an opportunity to do more to protect women considering breast implants," device center head Jeff Shuren and FDA Principal Deputy Commissioner Amy Abernethy said in the release.
In recent weeks, other countries have taken a particular type of textured implant made by Allergan off the market, citing a higher incidence of breast implant associated anaplastic large cell lymphoma (BIA-ALCL), a rare form of cancer, in certain textured implants than in smooth ones.
But FDA said it lacked definitive evidence proving those textured devices met the banning standard set forth in the Federal Food, Drug and Cosmetic Act, adding those implants only had a limited presence in the U.S. market.
"In 2018, textured breast implants represented less than 10% of breast implants sold in the U.S.," FDA said. "The type of macro-textured implants targeted by some of our international counterparts represents less than 5% of breast implants sold here."
Although the bans in other countries primarily targeted a specific type of textured implant sold by Allergan, some analysts saw FDA's less restrictive decision as a boon to specialized manufacturers like Sientra.
"We anticipate a market shift from textured implants toward smooth and near-term volumes to remain pressured as patients have been delaying surgeries to better understand implant safety, though most clinicians expect market demand to return over time," analysts at William Blair said.
FDA's choice to leave all textured implants on the U.S. market is "an unfortunate decision," president of the National Center for Health Research Diana Zuckerman said in an emailed statement to MedTech Dive. Patient and advocate Anne Ziegenhorn said the women who attended the meeting, and those whom they represented, are "very disappointed" in the lack of any restrictive action.
Still, those who had hoped for some kind of ban were encouraged by the possibility of working with FDA to develop a boxed warning and patient checklist. FDA also said it's "looking at ways to incorporate product ingredient information into the labeling in a way that is easy for patients to understand.”
"This is very important and will make a difference, if the physicians’ oral explanations to the patient are consistent with the risk information in the black box and patient checklist. Informed consent is a process, not a piece of paper," Zuckerman said. "What the doctors say and when they provide the information is key. Although the FDA didn’t promise either, I think they will follow through."
While FDA said it aims to improve patient and healthcare provider awareness of BIA-ALCL, particularly in textured implants, it also acknowledged it needed to get patients better information about the potential of developing systemic symptoms as a result of the implants. Part of that information sharing will include requiring breast implant manufacturers to file individual, publicly available adverse event reports. FDA said it will share all past data that was previously only available in summary reporting in the coming weeks.
The broader medical community also needs to better understand breast implants and their potential to cause a range of adverse reactions, FDA said. The agency said it is committed to improving outreach to gynecologists, dermatologists, and internists, and will work to educate pathologists about testing for BIA-ALCL.
FDA also strongly encouraged wider use breast implant registries PROFILE, which tracks BIA-ALCL diagnoses, and the new National Breast Implant Registry, which collects real-world data on the devices more broadly, but did not offer specific mechanisms on how to better incentivize or require participation.
"We are focused on strengthening the evidence generated to help inform future regulatory actions and to assure that women and providers are adequately informed of the risk of BIA-ALCL, including that the risk is higher with the use of textured implants, albeit still low," FDA said.
The agency indicated prior data collection efforts have been insufficient, sending warning letters to Sientra and Mentor ahead of the March advisory board meeting flagging poor execution of required post-approval studies.
Silicone breast implants are likely to come under further scrutiny this fall. A March 15 statement from former FDA head Scott Gottlieb and Shuren said the agency planned to take a closer look at safety of device materials, and the potential for certain ingredients to prompt allergic reactions.
More information on FDA’s "deep dive" into materials is likely to be released to the public in early fall, Shuren told an audience Thursday at the Food and Drug Law Institute's annual conference.