当前位置: 主页 > 天剑狂刀BT页游 >

“他们杀了她”:为何乳房假体仍有致死风险(10)

时间:2021-07-05 03:06来源:8N.org.Cn 作者:天剑狂刀私服 点击:

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?”

------分隔线----------------------------