U.S. eyes label warning for Allergen devices

FDA pressure results in breast implants that cause rare cancer of the immune system being recalled

Allergen is recalling its textured breast implants worldwide that have been linked to anaplastic large-cell lymphoma, a rare cancer of the immune system.

The company has responded to belated pressure from the Federal Drug Administration.

According to a recent story by Denise Grady in The New York Times, however, the FDA reports that women who have the implants but no symptoms don't need to remove them.

Yet the article does note "the recall means that doctors and hospitals should not implant any more of the devices and should return any on their shelves to Allergen."

The disease is not breast cancer but developed in tissues around the implant. "In most cases," Grady's story says, "removing the implant and the scar tissue around it cures the cancer, but if it is not detected early it can spread and kill the patient."

The condition, it continues, "has occurred with implants placed for cosmetic breast enlargement and with those used for reconstruction after mastectomy for breast cancer."

Thirty-three deaths and 573 cases have been reported from implants, Grady's piece reports, with a dozen deaths and 481 of them attributed to Allergen Biocell, according to the FDA, which dragged its heels after first recognizing the link to breast implants in 2011.

The Times story, which notes that the devices were banned months ago in Europe, contends that the "Biocell textured implants carry a risk that is about six times that of other textured implants sold in the United States."

Dr. Binita Ashar

It also reports that Dr. Binita Ashar, director of the FDA's Office of Surgical and Infection Control Devices, said at a news briefing…about the recall" that "hundreds of thousands of women in the United States have Biocell implants." 

The article also quotes Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, as saying that "the data regarding deaths was particularly informative of our decisions."

Main symptoms of the disease "are usually swelling and fluid accumulation around the implant," Brady writes.

FDA officials reportedly are considering "adding a black-box warning [to the labeling of the breast implants] to draw attention to the risks, and requiring doctors and patients considering the surgery to go over as checklist to help women understand the benefits and risks of the devices."

More information about implants can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book that I, Woody Weingarten, aimed at male caregivers.

2nd major ruling against Monsanto weedkiller

Unanimous U.S. court verdict labels Roundup as major factor in Sonoma man's non-Hodgkin's lymphoma 

In what might be a bellwether case, a six-person federal jury in San Francisco unanimously found this week that Roundup, Monsanto's weedkiller, was a substantial factor in a Santa Rosa man's cancer.

Or at least one active chemical ingredient in it — glyphosate — was.

The case could affect hundreds of others: Monsanto faces 9,000 similar lawsuits in the United States alone.

According to a story by Sam T. Levin in The Guardian, the 70-year-old plaintiff, Edwin Hardeman, said he'd used the herbicide for nearly three decades, had at least once gotten it on his skin, and "alleged that his exposure to [it] caused him to develop non-Hodgkin's lymphoma [NHL], cancer that affects the immune system."

In a second phase, the jury still must weigh liability and damage.

Hardeman, who was diagnosed with non-Hodgkin's lymphoma in 2015, has used Roundup to control weeds and poison ivy on his properties since the '80s.

A BuzzFeed News story notes that "Jennifer Moore, an attorney for the Sonoma County man, said Hardeman used Roundup regularly, spraying approximately 6,000 gallons of the herbicide over the course of 26 years."

The so-called bellwether trial, which means the verdict could possibly affect future litigation, followed a California state court verdict last August that Roundup caused the terminal cancer of Dewayne Johnson, a former school groundskeeper.

That jury, Levin's piece asserts, "said Monsanto failed to warn Johnson of Roundup's health hazards and 'acted with malice or oppression.'"

It awarded Johnson $289 million in damages, although that was later slashed to $78 million.

Monsanto, predictably, has appealed.

The Guardian story notes, however, that "Hardeman's trial has been more limited in scope. While Johnson's attorneys argued that Monsanto had 'bullied' scientists and fought to suppress negative studies about its product, the federal judge barred Hardeman's lawyers  from discussing Monsanto's alleged influence on research and regulations during the hearings."

Judge Vince Chhabria

Judge Vince Chhabria did, on the other hand, verbally flog the company on a procedural order during the trial by saying, "Although the evidence that Roundup causes cancer is quite equivocal, there is strong evidence from which a jury could conclude that Monsanto does not particularly care whether its product is in fact giving people cancer, focusing instead on manipulating public opinion and undermining anyone who raises genuine and legitimate concerns about the issue."

Despite the latest verdict, Monsanto, which has been bought by Bayer for $63 billion, continues "to argue that Roundup is safe to use and does not cause NHL."

The Hardeman trial is in effect a test case for almost 800 others nationwide that were consolidated. At least six more trials, according to MarketWatch, are expected to start this year in federal and state courts.

Details on other court cases about products that cause disease can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book that I, Woody Weingarten, aimed at male caregivers.