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May 19, 2020

Good morning, Broadsheet readers! The Fortune 500 loses a female CEO, shareholders are still watching gender diversity closely, and Fortune investigates the risky business of breast implants. Have a lovely Tuesday.  

-A different kind of health concern. Today’s essay comes from our Fortune colleague Maria Aspan:

Early last year, one of my friends had a terrifying conversation with her doctor. In 2014, after her mother died of cancer and my friend discovered she carried a genetically high risk of eventually developing the disease, she had decided to protect herself with a preventative double mastectomy and reconstruction—“the Angelina Jolie surgery,” as she called it. Those procedures replaced her natural, cancer-prone breasts with implants that were supposed to be safer.

But five years later, my friend’s surgeon delivered a new warning: Her type of breast implants had been linked to a different sort of cancer, and the odds of getting it seemed to be getting worse. Suddenly, something that was supposed to help her physical and mental health was instead putting her at risk.

That’s a familiar refrain when it comes to breast implants, as I found in the course of a months-long investigation for Fortune’s June/July issue. Even though the devices have been on the market since the 1960s, and have been sold to more than 8 million American women since 2000, breast implants have been plagued by a long history of product recalls, lawsuits, government bans, and various health issues affecting the women who have them—up to and including death.

“There are a lot of women who are really suffering,” Diana Zuckerman, a scientist and president of the National Center for Health Research, told me. “You have these products that are widely, widely sold, and every few years we learn something new about the problems they cause.”

The most serious and sometimes fatal of those problems is a cancer of the immune system known as BIA-ALCL, for “breast implant-associated anaplastic large cell lymphoma.” More than 903 women have been diagnosed with the disease, which has been linked in academic studies to breast implants with a “textured” silicone shell, and more than 33 women have died from it. Women with textured implants made by Allergan, now owned by AbbVie, are at especially high risk of developing BIA-ALCL, according to the FDA, which in July asked the company to recall its textured implants from the market.

But, as I discovered when I started talking to women all over the U.S.—or, in one tragic case, to their survivors—Allergan’s recall didn’t fix all of the problems with breast implants. BIA-ALCL can sometimes take a decade or more to develop, as it did in the case of Paulette Parr, who died of the lymphoma last summer, at age 68. And it’s only one of many health complications that women with breast implants have been reporting for years.

Many of these concerns have long been ignored, or worse. Until 2019, the U.S. Food and Drug Administration allowed manufacturers to report problems with their implants in a hidden, non-public database. Meanwhile, Allergan and its major competitors (Johnson & Johnson and Sientra) have all failed to comply with FDA requirements to study the long-term effects of their implants on women’s health. (In separate statements to Fortune, all three companies say that they prioritize patient safety.)

The FDA’s Binita Ashar told me that the agency is finalizing a black-box warning label for breast implants, and is prepared “to take further action if necessary to protect patients.” A week after we spoke, the FDA did just that, sending more warning letters to breast implant manufacturers over their compliance failures.

Some of the women I spoke with remain happy with their breast implants—or at least with the option to have them. For example, even after having another surgery last year to replace her textured implants, my friend says she doesn’t regret getting them. For her, the risks associated with breast implants remain much lower than her hereditary genetic risk of developing an aggressive breast cancer.

But it’s impossible to weigh those risks, and to give your informed consent to any sort of medical procedure, if you don’t have information on all of the known dangers. “Everybody loves their implants ‘until.’ My ‘until’ was 18 years,” says Carol Small, a breast cancer survivor who got a textured implant in 1999 and was diagnosed with BIA-ALCL in 2017. “We need to have good, informed choices.”

Read the full story here.

Maria Aspan
maria.aspan@fortune.com
@mariaaspan

Today’s Broadsheet was produced by Emma Hinchliffe. 

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PARTING WORDS

"We chose this life. Everybody else has been forced into it. But I think you could turn that around and just embrace reality the way it is and not fight against it."

-Sister Judy Murray, a nun at the Carmelite Sisters of Baltimore, on being cloistered or quarantined 

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