FDA Releases Plan For Better Labeling of Medical Devices

Federal health regulators are considering new product labeling rules, which would better inform patients and doctors about medical device risks with implantable products. The move comes after a string of problems in recent years with products like Essure birth control implants and metal-on-metal hip replacements, which were found to contain materials that could cause adverse health reactions.

The FDA recently published a discussion paper on how patients and healthcare providers should be provided information about the materials used in medical implants.

The discussion paper was created by the agency’s Center for Devices and Radiological Health (CDRH), and serves as a starting point for how the agency could improve device labeling. The FDA is seeking public comment and responses to help drive the conversation forward, officials said.

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“The safety of materials from which certain devices are manufactured or processed has generated substantial interest from stakeholders who want to be better informed regarding medical device materials and their impact on the benefits and risks of medical devices,” the discussion paper states. “The objective of this discussion paper is to provide an initial framework to stimulate discussion and to solicit feedback from a variety of stakeholders on how materials information could be communicated.”

The paper indicates problems with the Essure birth control device, metal-on-metal hips and breast implants are all recent events that have led the FDA to believe it needs a better way of telling doctors and patients what materials are in implants, and what health effects they may cause.

The agency first began to express interest in the topic in 2019, when it announced it was reviewing a number of materials linked to adverse reactions such as hypersensitivity which were used in implants; particularly certain metals.

The current focus is on devices implanted in the body or used repeatedly for more than 30 days, and on those devices which have the highest risk of causing an adverse reaction. The agency seeks input on what the labeling changes should be and whether healthcare professionals should discuss the materials used in the devices with patients before implanting them. What kind of information should be conveyed and how is a major question being posed to the public and other stakeholders.

A number of these products have either been severely restricted or recalled from the market completely.

While they were accounted for the majority of all hip replacements in the United States, problems with metal-on-metal hip implants have caused most designs to be removed fro the U.S. market, either through recalls or decisions by manufacturers that they were not worth the trouble. The FDA warning indicates there are currently no metal-on-metal hip implants approved for use in the United States.

In December 2018, Bayer removed all Essure birth control implants from the market. Although it claims it was a marketing decision, the manufacturer removed the implants from markets worldwide as regulatory agencies raised concerns and placed restrictions on the implants’ use.

According to the manufacturer’s data, it has received at least 33,097 reportable events involving complications with Essure procedures, including 19 deaths. Although federal regulators warn that some of these incidents may be duplicates, the data provides concerning signals about the long-term risks associated with the sterilization implant.

In August, Bayer officials announced they would pay $1.6 billion to settle about 90% of all Essure lawsuits filed by women who claimed they were left with devastating injuries. However, the settlement does not address future claims brought by women who are likely to continue to experience problems from the birth control implant.

Public comments on the FDA discussion paper are due by August 18 and can be submitted at Regulations.gov.


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