Medical law

Women considering breast enhancement surgery in Arizona would get more information about what could go wrong under the terms of legislation given preliminary Senate approval last week.

SB 1001 says that beginning next year doctors must provide women with the risks of the implants used in breast augmentation surgery. That also would include all the materials that manufacturers provide, including any warning requirements from the federal Food and Drug Administration.

A final roll-call vote will send it to the House.

Sen. Michelle Ugenti-Rita, R-Scottsdale, said she agreed to sponsor the measure after a constituent told her the story of having serious medical problems related to the implants. The woman was hospitalized and ultimately had to have them removed.

But Ugenti-Rita said this isn’t some isolated incident.

"There are thousands of women across Arizona and the country who do experience almost an adverse reaction, like an allergic reaction, if you will. The senator said that should not be a surprise.

"If you can imagine putting something in your body that’s foreign, not everyone responds to it the same way," Ugenti-Rita said. "On top of that, these implants are made from chemicals and compounds that are really not designed to be in your body."

The measure also has the backing of Robyn Towt, who had a double mastectomy in 2017 after being diagnosed with breast cancer.

Towt has become a major proponent of the measure, which failed to clear the legislature last year, telling lawmakers that her doctor told her the implants "were perfectly safe."

But the result, she said, was "extreme health issues" which resolved themselves after she had them removed four months later.

Testifying this year to members of the Senate Health Committee, Towt told lawmakers there is now even more reason for them to act in ways to protect women. She pointed out that the FDA last year implemented a "black box" warning to inform patients that implants have been associated with development of a type of cancer of the immune system.

This legislation seeks to go farther.

It specifically requires the medical boards that oversee physicians to not only provide a description of the risks of the surgery and the implants, but to develop a checklist that would have to be provided to patients. At a minimum, the legislation says, that list must include information of breast-implant illnesses and, specifically, implant associated anaplastic large cell lymphoma, a particularly rare and fast-spreading disease.

And patients would need to be told how they can report "adverse events" to the FDA and other programs, as well as provided information about the National Breast Implant Registry which keeps track of not only devices that are implanted but also subsequent surgeries.

Sen. Sally Ann Gonzales, D-Tucson, said she had no idea that women were not getting this information. Gonzales said she is sensitive to the issue as a breast-cancer survivor, though she does not have implants.

"I hope that this will help in all of those going forward to make the right decision for themselves," she said.

Sen. Nancy Barto, R-Phoenix, said this kind of legislation is overdue.

"It’s really a shame that people have to be hurt before the right thing is done and patients are fully informed," she said.

"Informed consent is a basic medical process," Barto said. "And information is absolutely critical when women and any patient makes a decision that potentially could be life changing."

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