On the heels of a $72 million verdict against Johnson & Johnson this month for a baby powder cancer case comes a proposed FDA powdered glove ban. The agency wants to ban most talc powdered gloves in the United States.
Powdered Gloves pose Substantial Risk
On March 21, 2016, the FDA announced a proposal to ban most powdered gloves in the country. The FDA wrote that the gloves “pose an unreasonable and substantial risk of illness or injury to health care providers, patients and other individuals who are exposed to them, which cannot be corrected through new or updated labeling.” Risks include:
• respiratory allergic reactions
• lung inflammation
• post-surgical adhesions
Surgeon Gloves, Examination Gloves
FDA said the proposed ban applies to powdered surgeons’ gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove.
The ban is meant to protect patients and health care professionals from a danger of which they might not be aware, said Jeffrey Shuren, M.D., director of FDA’s Center for Devices and Radiological Health. Dr. Shuren added that the FDA takes such action only when the agency feels it is necessary to protect the public health.
Respiratory, Allergic Reactions
The FDA explained that powder is added to some gloves to make it easier to slide them on and off; but powdered gloves are dangerous for several reasons. Aerosolized glove powder on natural rubber latex gloves (but not on synthetic powdered gloves, according to FDA) can carry proteins that may cause respiratory allergic reactions. FDA added that although powdered synthetic gloves do not present the risk of allergic reactions, they are associated with an extensive list of potentially serious adverse events, including severe airway inflammation, wound inflammation, and post-surgical adhesions – bands of fibrous scar tissue that form between internal organs and tissues. These effects have been attributed to the use of glove powder with all types of gloves.
FDA Powdered Glove Ban
The proposed rule is available online at www.regulations.gov for public comment for 90 days.