Breast implant information law clears committee
PHOENIX - Women who want to get breast implants would be required to get more information about the side effects, under the terms of legislation approved Wednesday by a Senate committee.
But not this year.
The unanimous vote in favor of SB 1439 followed testimony by several women who told the Health and Human Services Committee about the health effects, often lasting years, after they had implants.
More to the point, the women all said that they never were informed of what could go wrong.
No one from any of the manufacturers came to testify against the measure.
There also was no opposition from surgeons. In fact, James Nachbar, a Scottsdale plastic surgeon and attorney, told lawmakers he supports the measure.
In essence, the measure puts together a group including doctors, manufacturers and patients to come up with an "informed consent checklist'' of what physicians should discuss with patients considering breast implants.
At the very least, the legislation requires that list to include cancer associated with breast implants as well as other breast implant illnesses. And patients would have to be told of the National Breast Implant Registry which keeps track of not only devices that are implanted but also subsequent surgeries.
"I asked all the right questions for over a year,'' Lisa Roland told lawmakers.
"I wasn't told about auto-immune conditions,'' she said. "I wasn't given a manufacturer's booklet."
Roland said this isn't a simple matter of requiring a consent form. In fact, she said, the current form used by plastic surgeons is written at the collegiate level.
"It's 13 pages long,'' she said.
"I am health-literate,'' Roland continued. "It took me an hour and 48 minutes to read this thing.''
What SB 1439 would require, she said, is different.
"It clearly spells out all of the risks that I wish I had known before my implant surgery,'' Roland said, the surgery she said left her sick for 18 years.
Robyn Towt had her own story for lawmakers. She told of her double mastectomy in 2017 after being diagnosed with breast cancer. She said she had breast reconstruction with one of the top board-certified plastic surgeons in the East Valley, whom she did not name.
"My doctor told me breast implants were perfectly safe," Towt said, even with silicone.
"I ended up having extreme health issues,'' she said, having been given no idea what chemicals were in the implants. Towt said she had them removed after four months "and my 23 symptoms resolved within 48 hours.''
Gretchen Goodell-Bridge said the side effects of her own implants were so severe, including hair loss and heart palpitations, she had to stop working as a women's health nurse practitioner until she had them removed.
"It shouldn't be this way,'' she said.
"Women should know all the risks about a procedure,'' Goodell-Bridge said. "It is the surgeon's responsibility to inform the patient of all the negative things that can happen.''
She acknowledged that not every woman who had implants will get sick.
"But a proper informed consent means being given all the relevant information to make an educated decision,'' Goodell-Bridge said.
The reason this won't happen immediately -- assuming the bill clears the full Legislature -- is that study committee. It has until the end of the year to come up with that checklist.
But even a checklist and a consent form, Roland said, isn't the entire answer.
"I talk to a lot of women that say that they were just handed their consent forms and they were told to sign them,'' she said. Roland said that this legislation "has the potential to change that culture.''
That includes telling women they should go back to their surgeons when their immune systems react badly and that they should report their problems to the Food and Drug Administration which regulates the devices.
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