In early 2019, after Europe halted sales of Allergan’s textured implants, Parr had hers removed and continued the chemo her oncologist promised would eliminate her BIA-ALCL. Her long blond hair started to fall out, and she eventually asked Calvin to cut it all off with his barber clippers.

In Maryland, the FDA was convening hearings to discuss the disease and the overall safety of breast implants. “Cases of BIA-ALCL have been reported in patients with an implant history that includes textured implants,” Dr. Stephanie Manson Brown, Allergan’s VP of clinical development for devices, testified. “What is important is that the prognosis is excellent, especially when identified early and treated appropriately.”

But in May, as the FDA said it would not ban textured breast implants, Parr’s tests showed that her lymphoma had metastasized. In June, as AbbVie announced its plans to buy Allergan, she spent the month hospitalized and undergoing more treatments. Eventually, her doctors told her that her health was too poor for her to qualify for an experimental treatment that seems to be effective for other patients with BIA-ALCL.

“She suffered an awful lot,” Calvin says, his Southern drawl thickening. “Her legs got so big that she couldn’t even put them together, her arms swelled up…and then we were just sitting and waiting for the end.”

Finally, on July 24, the FDA asked Allergan to recall its Biocell textured implants. The agency would later upgrade the recall to its most serious “Class I” designation, warning that “use of these devices may cause serious injuries or death.”

It all came too late for Paulette Parr. Twenty-nine days after the recall, after spending her 68th birthday in a St. Louis hospital bed, she died.

To Parr’s husband and his lawyer, Nashville-based David Randolph Smith, her death from BIA-ALCL is evidence of one implant-maker’s negligence. But when grouped with others, it suggests a systemic failure in a global industry that had never put patient safety first.

Parr’s lawsuit is part of the Biocell-related multi-district litigation Allergan, and now AbbVie, are facing. Large-scale suits against big pharma companies can sometimes result in multibillion-dollar payouts, as happened in the 1990s against implant maker Dow Corning. Industry experts say it’s too early to estimate AbbVie’s potential exposure, but “it’s definitely an issue we’re watching,” says Mizuho senior analyst Vamil Divan.

But even the plaintiffs’ lawyers acknowledge that lawsuits against medical device manufacturers are difficult to pursue, because individual claims filed are often preempted by the FDA’s preexisting approval of the products. “Even if there is something wrong with this product, you are not entitled to bring this action, because it has already gone through this strict federal approval process,” is how Jennifer Lenze, a lawyer representing the plaintiffs in the Allergan litigation, describes the preemption argument.

Whatever the eventual legal outcome, the problems with breast implants are clearly affecting their sales. Even before the COVID-19 pandemic shut down elective procedures, plastic surgeons were reporting a drop in demand. Scot Glasberg, a former president of the American Society of Plastic Surgeons, says that in the year following the FDA’s 2019 hearings, “we have seen the number of breast augmentations go down about 10%,” with “explants” up about 15%.

“I’ve been taking out more implants than I’ve been putting in,” Kevin Brenner, a Beverly Hills plastic surgeon, said in March. The Allergan recall made many of his patients concerned about developing the lymphoma, but also raised awareness about BII, he says.

Whether the breast implant business will eventually recover remains to be seen—especially now that its problems have been amplified by the pandemic and resulting economic downturn. Breast augmentations fell after the last recession, as consumers cut back on nonessential spending. During AbbVie’s May earnings call, CEO Richard Gonzalez acknowledged that he expects the contraction to have a “pronounced” if “transient” impact on Allergan’s medical aesthetics business.

For Calvin Parr, the pandemic means rattling around the house he shared with Paulette and trying to get used to a more permanent sort of isolation. One of his daughters lives across the street, so he’s able to break up the days with visits from his grandchildren. But sometimes he wakes up at night and feels the bed for his wife, before remembering she is gone. “I’ve got nobody to hang on to,” he says.

A year ago, he and Paulette were still planning the rest of their retirement together. “All of our life, I was the one making arrangements to make sure Paulette would be taken care of. We knew I’d be going first,” he says. “But then they killed her. The damn implants killed her.”

A brief history of breast implants

The devices are approaching a half-century of controversy.

1976

Congress gives the FDA the authority to regulate medical devices. Silicone breast implants, on the market since 1962, are grandfathered in.

1984

Maria Stern, who claims her Dow Corning silicone implants made her sick, wins $1.5 million in punitive damages.

1992

After more lawsuits and congressional hearings, the FDA calls for a moratorium on most silicone implants.

1995