Jul 24, 2019

Allergan breast implants linked to rare cancer face global recall

The Food and Drug Administration requested that Allergan, a company that manufactures textured breast implants, voluntarily recall the devices on Wednesday, based on their link to an unusual form of cancer.

Why it matters: 573 cases and 33 deaths from anaplastic large cell lymphoma have been reported around the world, according to FDA data. Of the 573 cases, 481 have been attributed to the Allergan product.

Anaplastic large cell lymphoma is a cancer that affects the immune system. It is not breast cancer, but forms around the tissue of the implant.

Of note: Women who have these implants, but go undiagnosed, should not have them removed. The recall is to only stop doctors from further using the implants.
Symptoms include swelling and pain around the breasts. Fluid accumulation around the implant can also occur and should be drained and tested for cancer if symptoms persist, per the FDA.
Taking out the implant and scar tissue can cure the cancer. The disease can be fatal if not detected early enough.

The big picture: Textured implants account for only about 5% of the implants used in the U.S. The product is more common in Europe, where it has already been recalled in many countries, the New York Times reports.

Allergan told the FDA it will remove BioCell textured breast implants and tissue expanders from the markets in which they're sold.

A list of those models can be found here.

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Caitlin Owens

Endo and Allergan discussing opioid settlement to avoid trial

Photo: Liz O. Baylen/Los Angeles Times/Getty Images

Two drug companies — Endo and Allergan — are in discussions about a settlement that would allow them to avoid participating in a massive opioids trial set to occur this fall, the Wall Street Journal reports. Endo is working on a $10 million deal, while Allergan is negotiating a $5 million deal that may not completely remove it from the trial.

Why it matters: These 2 companies are relatively minor players in the trial, especially compared to drugmakers like Purdue Pharma and Johnson and Johnson. But this would still be a significant development, especially if other drug companies end up following Endo and Allergan's lead to avoid going to trial.

Go deeper: A proposal to bring all local governments into opioids settlement

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Orion Rummler

CDC probes 153 possible cases of lung illness associated with vaping

A man smokes an e-cigarette in Washington, D.C., on July 9. Photo: Alastair Pike/AFP/Getty Images

The CDC is working with the Food and Drug Administration (FDA) and state health officials to gather information on new cases of lung-related illnesses possibly caused by vaping, per a Wednesday press release.

What's happening: 16 states have reported 153 possible cases of "severe lung illness associated with e-cigarette product use" between June 28 and August 20, according to the CDC. There is no evidence that an infectious disease is the culprit of the illnesses and no deaths have been reported, per the CDC.

Go deeperAug 22, 2019

Sam Baker

FDA: World's most expensive drug was approved using faulty data

The company that developed the most expensive drug in the world knew about problems with its clinical data, but withheld that information from the FDA until after the drug had been approved, the agency said Tuesday. Nevertheless, the FDA said it's confident that the drug, Zolgensma, is still safe.

Between the lines: Zolgensma is a gene replacement therapy to treat spinal muscular atrophy in children younger than 2, manufactured by Novartis. It was approved in May and carries a $2.1 million price tag. In disclosing the faulty data submission, the FDA said it "will use its full authorities to take action, if appropriate, which may include civil or criminal penalties."

Keep ReadingAug 6, 2019