Arizona Passes Legislation to Require Breast Implant Patients to Sign Consent Checklist

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Tucson, AZ plastic surgeon Raman Mahabir, MD says a recent bill passed in his state requiring breast surgery patients to sign a consent checklist is the culmination of a lot of hard work by the Arizona Society of Plastic Surgeons and national plastic surgery societies. “It was signed into law by Governor Doug Ducey and takes effect January 1, 2022 as the planned implementation date,” says the surgeon. 

Dr. Mahabir says Arizona’s SB 1001 requires patients considering breast implants to sign a checklist that outlines the risks associated with implants. The checklist includes information about breast implant illnesses, side effects associated with implants, and details about the National Breast Implant Registry, which registers an individual’s implant and surgery information.

As of yet, Arizona is the first state to pass such legislation, but Dr. Mahabir says he and colleagues at the Arizona Medical Association are working to get similar bills passed in other states and eventually on a much larger scale. “The legislation is now being used as a template in many other states. The most progress has been made in Washington state and New Jersey,” he adds. “Our goal is to target 12-13 key states, get similar bills passed in those states, then leading to a federal bill which would be the culmination of that work.”

Many board-certified plastic surgeons find the bill to be a positive step in reinforcing what they’re already doing, which is educating their patients while ensuring their utmost safety. “I believe the Arizona action is an expected result of the most recent communication from the FDA that also includes a recommendation for a patient checklist as a part of the consent process,” says Louisville, KY plastic surgeon M. Bradley Calobrace, MD. “I am certain the thoroughness of the consent process has been quite variable among surgeons and this process attempts to ensure similar information is received by all patients prior to augmentation.”

“I completely support a checklist prior to breast implant surgery outlining the most common risks and important information patients should have prior to surgery,” says St. Louis, MO plastic surgeon Patricia McGuire, MD. “These checklists are not a substitute for full informed consent, but have been requested by patients who feel they were overwhelmed by the informed consent process. I am part of an FDA collaborative community which has written our own checklist that we are refining and hope to submit to the FDA in the near future.” 

While the Arizona checklist has not been finalized as of yet, Eugene, OR plastic surgeon Mark Jewell, MD says that some warnings currently included may need further clarification as to not scare patients away: “My published research indicates that women with breast implants have no greater incidence of lactation-related issues than women who don’t have them,” he notes. “I also do not believe that breast implants make patients susceptible to Lyme disease.”

Las Vegas, NV plastic surgeon Michael Edwards, MD notes that despite the moves to require a checklist, there is still ongoing research happening on breast implant–associated illness and patients should stay informed as new studies continue to be published: “Until more information is known, I recommend patients seek care with an experienced, board-certified plastic surgeon who will listen to you, review your options and help you come to a treatment plan that is most appropriate for you.” 

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