The Food and Drug Administration decided not to ban the sale of textured implants yet. This is despite recognizing that they may increase the risks of cancer and autoimmune conditions among women.
In its press release on May 2, Thursday, the agency said it needed more concrete scientific evidence linking these implants to the diseases.
It also revealed that textured breast implants, which are the likely cause of these conditions, account for only a small percentage of the total implant sales in the United States.
"At this time, the FDA does not believe that, on the basis of all available data and information, the device meets the banning standard set forth in the Federal Food, Drug and Cosmetic Act," it said.
Other countries where textured implant market shares are high have already banned or restricted their distribution. In 2015, Brazil suspended the production and sale of Silimed products after failing to pass the inspection.
Stronger Breast Implant Risk Warnings
The FDA, however, plans to undertake numerous steps to improve patient information and educate healthcare providers about the dangers of these breast implants. Most of these proposals stemmed from a two-day public advisory committee meeting last March.
It wants to provide more information about the risks of breast implant-associated anaplastic large cell lymphoma and systemic symptoms that can include chronic fatigue, joint pain, and cognitive problems.
It also wants to change the labeling of the products, which may mention the product ingredient and include a boxed warning. It will work with other stakeholders such as patient groups to create the ideal format and content for these labels.
The education will also extend to healthcare providers and pathologists who need to learn how to test breast-implant-related lymphoma.
Changes In Medical Device Reports
The issue of breast implant risks will also change the way manufacturers file their medical device reports.
Before, they submitted a summary report of any issues or concerns encountered by the users, but they didn't include adverse events such as BIA-ALCL.
Today, the FDA mandates them to provide individual medical device report, which the public can access through the Manufacturer and User Facility Device Experience database.
In the coming weeks, the agency plans to terminate all forms of alternative summary reporting for the rest of the medical devices.
The agency, however, issued a caveat, saying the public cannot use the number of the reports to determine the frequency of these adverse events. It also doesn't verify the accuracy or the timeliness of these data.
These steps have been commended by some, including Madris Tomes, who created a tool to search these adverse events in the FDA database, calling it a step in the right direction.
