“他们杀了她”：为何乳房假体仍有致死风险

For the next 15 years, through losing her first husband and remarrying and getting promoted to her hospital’s purchasing department, Parr was mostly happy with her implants, and with how they made her look and feel. But they were silicone-based, a type the U.S. Food and Drug Administration banned in 1992 over concerns that they were causing autoimmune and safety problems, and Parr eventually started to worry about them. So by 2002, when she learned that one of her implants had ruptured and was leaking silicone into her body, Parr’s surgeon replaced them with saline-filled versions. Her new Biocell implants were covered in a roughly textured silicone shell, designed to reduce movement of the device.

That’s when Parr’s implant-related health problems really began, according to a lawsuit her husband has filed against pharmaceutical company Allergan, the maker of Biocell products and one of three major manufacturers of American breast implants. In 2010, after one of her saline implants started leaking, her plastic surgeon replaced them with yet another set of Biocell textured implants, this time filled with silicone, which the FDA had allowed back onto the market in 2006.

“They were gorgeous, and they were put in by a reputable doctor,” says Paulette’s widower, Calvin Parr, months after her death. “We never gave it a second thought.”

Breast implants have long been a punch line, mocked as frivolous markers of female vanity. But that dismissive attitude overlooks a business with a serious and sometimes deadly impact on the health of its overwhelmingly female customer base. More than 8 million American women have undergone breast-related plastic surgeries since 2000; in 2018 alone, more than 400,000 women chose one for either cosmetic or reconstructive reasons. Breast augmentation is the most popular cosmetic procedure tracked by the American Society of Plastic Surgeons.

Many women, especially those affected by breast cancer, say they are grateful to have implants as an option. “It’s a decision that’s personal,” says Lynn Jeffers, the society’s current president, a plastic surgeon, and a cancer survivor who’s getting post-mastectomy reconstruction. “With the data that I have now, I’m comfortable having implants.”

And pharmaceutical companies have been very comfortable selling them, despite a long history of government recalls and product-liability lawsuits. Allergan, which was acquired by AbbVie in May, sold $399.5 million worth of implants in 2017, before regulators around the globe started banning some of its products. Its main rival, Johnson & Johnson, doesn’t break out results for its Mentor Worldwide breast implant business. Smaller specialist Sientra reported annual “breast products” revenues of $46.4 million in 2019.

Those numbers pale in comparison to blockbusters like Allergan bestseller Botox, which raked in $3.8 billion last year. But like Botox, breast implants can have attractive recurring revenue built in for manufacturers and the doctors who use their products. Even under ideal circumstances, breast implants “are not lifetime devices,” the FDA warns, and will likely need to be replaced every 10 to 15 years, for a cost of up to $12,000 per cosmetic procedure.

Yet as doctors, patients, lawyers, and public health experts tell Fortune, breast implants have remained on the market despite decades of inadequate testing and study, recurrent safety concerns, and poor regulatory oversight. Those problems plague many medical devices, which range from machines used outside the body to artificial parts implanted within it. But breast implants are unique in their affiliation with female sexuality and physical appearance, their intersecting roles as elective beauty products and clinical tools that can help cancer survivors feel more like themselves—and the degree to which patients’ mounting concerns about them have been dismissed for decades. Now, that accumulated failure of oversight has created sweeping, sometimes tragic crises for potentially millions of women.

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

Breast implant makers walk a particularly fine line when it comes to creating a product that is both safe and “realistic.” Today’s implants are either filled with saline (more likely to break) or silicone (more natural looking and feeling but plagued by a history of safety concerns). Their exteriors can be either smooth or made of a “textured” silicone shell. Smooth implants are more popular in the U.S., but surgeons working with mastectomy patients sometimes prefer textured versions, because the products’ rougher surface enables tissue to grow onto the implant more easily.

All of these variations are prone to malfunctions or side effects, which can include ruptured implants; a buildup of scar tissue that can cause pain and tissue hardening; a large collection of symptoms often known as “breast implant illness,” which can include joint pain, migraines, and chronic fatigue; and, increasingly, a sometimes fatal cancer of the immune system known as ¬BIA-ALCL, for “breast implant–¬associated anaplastic large cell lymphoma.”

“The breast implants that are on the market right now all have issues,” says Madris Tomes, a former FDA manager who tracks reported medical device failures at her Device Events firm. “I wouldn’t recommend them to anyone that I care about.”

The causes of the various problems with breast implants are still poorly understood, which public health experts blame on a lack of testing or objective, long-term studies that do not rely on manufacturer-provided data or funding. Device makers also have yet to fully report the data the FDA required as a condition of allowing silicone implants back on the market in 2006.

The cost of embracing such troubled devices became painfully clear last year, after a surge in cases of BIA-ALCL. More than 903 women have now been diagnosed with that once-rare lymphoma, and more than 33 have died. Hundreds of thousands of others are estimated to be at risk of developing the disease, which can take decades to surface and has been linked to textured implants in academic studies. Cases of the lymphoma have been reported in women with implants from various manufacturers, including Johnson & Johnson and Sientra. But Allergan’s Biocell implants have by far the worst record of affected patients. By the end of 2018, European regulators stopped Allergan from selling textured implants. The FDA was slower to respond, but in July 2019 it finally asked Allergan to recall those devices from the market, citing BIA-ALCL. The company complied and suspended future sales.

By May, Allergan was facing about 48 lawsuits, including some class action claims, related to BIA-ALCL and its recalled implants. Alleging that problems with Allergan Biocell implants have caused injury, financial losses, and wrongful death, these cases have now been consolidated in a multi-district litigation in the U.S. District of New Jersey.

An Allergan spokesperson told Fortune via email that the company does not comment on pending litigation, adding that it “has a demonstrated history of dedication to the health and safety of patients” and “has followed FDA regulatory reporting procedures and acted transparently with patients about textured breast implants.”

In emailed statements to Fortune, Sientra did not address the linkages of BIA-ALCL to its textured implants, while Johnson & Johnson acknowledged “a low number of BIA-ALCL cases reported” in Mentor textured implants. Both companies said they prioritized the safety of their patients.

Binita Ashar, a general surgeon and director of the FDA’s Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health, also calls women’s safety a priority. “We know more about breast implants today than we did 10 years ago, and we continue to learn more,” she says. “We will not hesitate to take further action if necessary to protect patients.”

“My surgeon basically told me, ‘Remember all the issues from the ’90s? They fixed all that,’ ” recalls Maria Gmitro. Such dismissals of the risks involved with breast implants mean “patients do not have accurate information to make informed choices about our health,” she says.

Gmitro, who says she developed rashes and chronic fatigue after buying Mentor implants in 2014, is part of a growing cohort of women trying to get doctors to take implant-related health complaints more seriously. BIA-ALCL has drawn attention to more common health issues, including the constellation of symptoms known as “breast implant illness.” BII does not have an official diagnosis; some of its symptoms resemble autoimmune disorders. One Facebook group devoted to BII has more than 100,000 members, who trade symptoms and stories of relief after removing their implants—but patients say many doctors are quick to dismiss medical information that comes from such sources.

“Even now there’s a large part of the community that’s not taken seriously,” says Jamee Cook, a patient advocate who’s now on a breast implant task force with plastic surgeons. “But we’ve been able to sit at the table and have people realize that we’re not crazy, we’re educated women, and we have been harmed.”

At the very least, these patients say, implants have been marketed to women for years without adequate warnings from either manufacturers or surgeons, denying women their right to informed consent about the risks involved. Little tracking of medical devices exists in general, owing in part to the decentralized nature of the business. The FDA regulates manufacturers, not doctors; manufacturers sell their implants to plastic surgeons, yet patients are the end users and the ones in charge of keeping track of which implants they have. Historically, this was done through the extremely analog system of giving patients a card with their implants’ unique tracking number on it. If you lose that piece of paper, and your surgeon retires or destroys records after seven years, good luck figuring out which breast implants you got—or whether they’ve been recalled.

While better tracking systems are being developed, many patients affected by the Allergan recall say they found out about BIA-ALCL from the news or social media rather than from their doctors, Allergan, or the government.

“When I bought a new car that turned out to have a faulty air filter, my car dealer sent me three postcards and followed up with a phone call reminding me to bring it in,” says Raylene Hollrah, a breast cancer survivor and implant patient advocate who was diagnosed with BIA-ALCL in 2013. “But I have something in my body that causes a cancer that the FDA knew about—and hear nothing?”

When a medical device malfunctions, manufacturers are required to report it to the FDA’s publicly available database. But until 2019, the agency also allowed companies to file private “alternative” summaries of malfunctions. These allowed more than 300,000 reports of breast implant problems to remain hidden since 2009, the FDA acknowledged last year. “This was an approach to be more efficient, and when we recognized that there was a concern, we eliminated it,” says Ashar, adding that the reports are now public.

Tomes of Device Events says she met with the FDA in 2017 to discuss her findings that Allergan had, in some instances, reported problems with devices under the company name “Costa Rica” or “Santa Barbara” (locations where their implants were made), but not under “Allergan.” She shared documents from the meeting with Fortune, saying: “If you’re a physician, you go to the FDA database, and you’re going to look up the name Allergan, not Costa Rica. They were putting off the identification of the problems as long as they could.” (The FDA says it does not comment on individual meetings. The records now include the company name.)

An Allergan spokesperson says the company has “always worked to fully meet all FDA requirements, including our adverse event reporting obligations” and that it currently sends “all adverse event reports to FDA with full and accurate information using the company name and manufacturing location of the implant.”

When the FDA lifted its ban on silicone implants in 2006, it required manufacturers to conduct large, 10 year studies of the women who have their implants. Last year, Mentor and Sientra received “warning letters” from the FDA over their failure to track enough women over time. Both have been allowed to continue selling their products; Ashar says the FDA is “monitoring Mentor and Sientra’s progress” but would not provide specifics. J&J and Sientra both say they are working to increase patient participation in their studies.

A week after Ashar spoke with Fortune for this story, the FDA sent two more warning letters to breast implant manufacturers, citing its “ongoing efforts to protect patients.” One letter, to Allergan, said the company also failed to adequately study the risks of its now-recalled implants once they were on the market. The other letter, to privately-held Ideal Implant, said the company has failed to fix manufacturing and quality-control problems the FDA discovered during an inspection earlier this year. Ideal is also violating requirements for reporting problems with its implants, according to the letter.

The FDA gave both companies 15 working days to respond to its warnings. An Allergan spokesperson said the company is reviewing the letter and “takes this matter seriously.” A spokesperson for Ideal Implant said the company is working closely with the FDA and “strongly supports timely and accurate reporting on product safety.”

The agency is also considering more proactive regulation of future implant sales. In October, the FDA proposed adding a more severe black-box warning label to breast implants, along with an explicit patient-decision checklist. The proposal received more than 1,000 “mostly favorable” public comments, according to Ashar, who adds that “finalizing the guidance is a top priority for the agency.”

“A woman is more likely to be struck by lightning than get this condition,” an Allergan spokeswoman declared. It was January 2011, more than a decade after the first reported case of lymphoma tied to breast implants. The FDA had just issued its first public warning that women with breast implants “may have a very small but increased risk of developing” a disease then called anaplastic large cell lymphoma (ALCL). And in Missouri, Paulette Parr had just gotten her second set of Biocell implants.

At the time, there had been only about 60 cases of ALCL reported worldwide, and manufacturers were quick to downplay the risks. Yet the danger—at least to its bottom line—was grave enough for Allergan to warn investors about the potential negative consequences of the disease, including bad press and financial losses. “The manufacture and sale of breast implant products has been and continues to be the subject of a significant number of product liability claims,” the company warned in March 2011.

The risks of the breast implant business hasn’t dented the company’s prospects as an acquisition target. In 2015, Dublin-based Actavis bought Allergan and assumed its name; four years later, CEO Brent Saunders agreed to sell the combined company to AbbVie, maker of Humira. The $63 billion deal, announced in June 2019 and closed in early May, enables AbbVie to diversify into Botox, breast implants, and the other “medical aesthetics” which, Saunders told CNBC’s Jim Cramer, is “the best business in the biopharmaceuticals space. It’s highly durable, it’s cash pay all over the world, and it’s less regulated, so we don’t have to deal with government payers,” he said.

As Allergan rode the M&A merry-go-round, the chances that a woman with breast implants would be diagnosed with BIA-ALCL climbed from one in 500,000 in 2011 to one in 3,800 in 2019. Peter Cordeiro, a Memorial Sloan Kettering plastic surgeon who followed his patients for 27 years and almost exclusively used Allergan implants, estimates that his patients now have a one in 355 chance of developing the cancer.

But in 2018, the FDA still didn’t seem worried and neither was Paulette Parr—even when she noticed a pimple-size growth under her arm. She went in to have it checked, only to learn in November that she had this thing called BIA-ALCL.

Parr was 67 then, a newly retired grandmother, taking weekend jaunts to Memphis and looking forward to visiting New York City for the first time. And at first, her diagnosis didn’t sound so dire. The doctor told her, “You give me six sessions of chemo, it’ll be gone,” Calvin Parr recalls. “That relieved us really well.”

Problems with implants have increasingly complicated the health of one particularly vulnerable community: women with or at high risk of developing breast cancer.

Every year, more than 100,000 women—a quarter of breast-related plastic surgery patients—have “reconstructive” procedures, mostly after mastectomies. They don’t all have the disease; preventive mastectomies got a boost in 2013, when actor Angelina Jolie, who has a gene mutation that puts her at increased risk for breast cancer, wrote a New York Times op-ed about her decision to preventively remove her breasts and replace them with implants.

Today, such prophylactic mastectomies with reconstruction have become a reassurance for many young women who have seen their mothers and aunts and grandmothers die from aggressive cancers and who want to reduce their own hereditary risks. For these women, who don’t want to lose the femininity or sexuality associated with having breasts, implants have been life-changing devices.

“As somebody who was plagued with a fear of breast cancer my whole life, there was this amazing safety net,” says Caitlin Brodnick, a New York City comedian and the author of a memoir about her decision to have a preventive mastectomy and reconstructive surgery at age 28.

But one terrible irony of ¬BIA-ALCL is that many women who had the surgery to reduce their risk of cancer could now contract a new type.

“To lose all the women in my family to cancer, to make this decision that is supposed to save my life—and then, just kidding! This put me at a whole other risk,” says Mia Kargen, a nursery school director in Westchester County, N.Y., who underwent the double procedure in 2014. “It was so stressful. It affects every part of life.”

Replacing implants or even simply removing (“explanting”) them requires another expensive surgery and time for recovery. In one high-profile instance, Match Group CEO Mandy Ginsberg in March stepped down from her $2-billion-in-revenue company, citing in part the surgery she had just undergone to replace her recalled breast implants.

There are separate, equally devastating effects for women like Paulette Parr and the hundreds of thousands of others who still get implants every year for cosmetic reasons. For many of them, developing BIA-ALCL has come with a side of self-recrimination and external criticism—not to mention massive medical bills.

“With this cancer, you’re judged,” says Michelle Forney, an HR manager at a financial services company who has now developed BIA-ALCL. A briskly upbeat Californian, her voice falters and breaks as she talks about the guilt she felt about her diagnosis: “I gave it to myself. I put these implants in for vanity. But do I deserve this?”

Costs for treating the lymphoma can run from $200,000 to $300,000, not including the costs of missing work or traveling for treatment, according to Mark W. Clemens. An associate professor of plastic surgery at the University of Texas MD Anderson Cancer Center, Clemens is treating many of the women who have contracted BIA-ALCL and preparing a study of its financial impact. “For patients who received a cosmetic augmentation, some insurers have policy exclusions; they will not cover a patient who’s been diagnosed,” he says.

One such insurer is Premera Blue Cross, a Washington State licensee of Blue Cross Blue Shield. A policy from March states that if a patient’s implants were placed for cosmetic purposes, removing them is covered only “if there has been interval development of breast cancer or other breast disease that requires mastectomy or partial mastectomy.” BIA-ALCL is not considered a breast cancer or disease.

Premera declined to comment on specific cases, citing patient privacy rules, and noted that the FDA does not currently recommend explantation if women have not been diagnosed with BIA-ALCL. The insurer added that it makes decisions on a case-by-case basis. “Each case has its own intricacies that guide the clinical decision of coverage,” Chad Murphy, Premera’s chief clinical officer, said in an emailed statement.

Allergan has offered up to $7,500 to cover out-of-pocket surgery costs to any woman who has developed BIA-ALCL, and $1,000 toward diagnostic testing. That’s too little, too late for women like Forney and Hollrah, who have filed suit against Allergan. “It has cost me thousands and thousands of dollars, and I have good insurance,” says Forney. “Cancer is an expensive gift that keeps on giving.”

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 grand¬fathered 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

Dow Corning, facing more than 20,000 lawsuits, files for Chapter 11 (it would later agree to a $3.2 billion settlement). Separately, manufacturers Bristol-Myers Squibb, Baxter Healthcare, and 3M establish a settlement fund for women with damaged silicone implants.

2006

The FDA allows silicone breast implants back on the U.S. market.

2010

A government raid uncovers French implant maker Poly Implant Prothese’s use of an unapproved industrial-grade silicone; it shutters and its founder is jailed.

2018

Europe halts sales of Allergan’s textured implants.

July 2019

The FDA asks Allergan to recall the devices.

A version of this article appears in the June/July 2020 issue of Fortune with the headline "The Risky Business of Breast Implants."