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FDA Recommends New Warning for Breast Implants Amid Safety Concerns

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  • The Food and Drug Administration is recommending the implementation of a “boxed warning” on labeling material for breast implants.
  • The FDA is also recommending a patient checklist that would allow for more open discussions with doctors about the risks and benefits of breast implants.
  • In March, breast implant safety advocates pressured the FDA to warn women of the dangers of implants, following reports of ruptures, cancer, and autoimmune illnesses.

FDA Proposes Warning Labels

The Food and Drug Administration introduced a draft proposal Wednesday that recommends adding warning labels to breast implant packaging. 

The proposed label — known as a boxed warning — is the strongest form of warning the FDA can give and comes after years of pressure from breast implant safety advocates. In large part, the FDA is proposing the warnings because of recent concerns that silicone implants can lead to autoimmune breast implant illness or even a form of cancer known as breast implant-associated lymphoma. 

“We have heard from many women that they are not fully informed of the risks when considering breast implants,” the administration said in a statement, adding that the new recommendations are “designed to help inform conversations between patients and health care professionals when breast implants are being considered.”

The boxed warning would reportedly state that breast implants are not lifetime devices. According to the proposal, it will also state that the longer a woman wears an implant, the higher her chances for developing a complication are and that some of those complications could require more surgery. Another notable inclusion will be a warning saying that breast implants have been associated with the risk for cancer and other systemic symptoms. 

Source: FDA

The FDA is also proposing that manufacturers list the ingredients that go into their implants. This is aimed at addressing major concerns surrounding ruptured implants, as the silicone gel and toxic chemicals within them could pose harm to patients.

Of course, a written label and the names of chemicals can only do so much. One major area of concern is the fact that most patients aren’t going to see these implants before their procedure. 

FDA’S Proposed Checklist 

Because of those worries, the FDA is also proposing that breast implant manufacturers include what’s known as a patient decision checklist. That checklist would then allow patients to guide their surgeons through any questions they have about the risks and benefits of implants. 

It would also include conversations about situations in which the device should not be used or implanted and, among other topics, a discussion of options other than breast implants.

To help ensure patients and doctors review the material, the FDA is also recommending that the checklist have a section for signatures. 

Notably, both this checklist and the box warnings are measures advocates have asked for, with a Change.org petition garnering over 70,000 signatures.

Guidance Period

The FDA had proposed the recommendation as a draft to refine it over the next 60 days as the administration accepts public comments. 

However, it is important to note that the entire recommendation is non-binding, meaning manufacturers and doctors will not be forced to comply any further that the law permits in their communities. 

“After a period of public comment, once the guidance is finalized,” the FDA statement reads, “manufacturers may choose to follow the recommendations in the final guidance or they may choose other methods of labeling their devices, so long as the labeling complies with applicable FDA laws and regulations.”

Advocates Compel FDA to Take Action 

The proposal comes more than three years after advocates began pressing the FDA to address the situation.

Awareness around the safety of breast implants followed reports of fatigue and joint pain in women, followed soon after by additional reports of autoimmune illness and cancer. 

In March, advocates finally met with the FDA as it announced it would begin reviewing breast implant safety.

In July, breast implant manufacturer Allergan issued a worldwide recall on their implants after those implants had specifically been linked to cases of lymphoma.

See what others are saying: (Washington Post) (ABC News) (New York Times)

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Veteran Burial Problem: Why Veteran Cemeteries Are Running Out of Space & What’s Next

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Over the last few decades, veteran cemeteries throughout the US have been facing an ongoing problem — they’ve been running out of space. In an effort to address this, the US Department of Veterans Affairs, specifically the National Cemetery Administration, has been working to acquire new land to expand current national cemeteries and establish new ones.

They’ve also launched the Urban Initiative and the Rural Initiative in order to improve accessibility for veterans living in densely populated cities and in more rural parts of the country, respectively. But the challenges don’t end there. As it stands, national cemeteries are still at risk of running out of room within the next twenty to thirty years. And as a result, new changes are being proposed; changes that would impact eligibility requirements and potentially limit which veterans can and cannot be buried below ground. Watch the video to find out more.

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BART Apologizes After a Man Was Handcuffed for Eating a Sandwich on a Train Platform

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  • Protestors have staged “eat ins” and spoken out on social media in support of a BART rider who was handcuffed and cited for eating a sandwich on a train platform, a violation of CA law. 
  • BART’s General Manager noted that the man refused to provide identification, and “cursed at and made homophobic slurs at the officer who remained calm throughout the entire engagement.”
  • But still, the official apologized to the rider and said the transit agency’s independent police auditor is investigating the incident.

Viral Video 

A transit official in California’s Bay Area apologized Monday after a video showed a man waiting to catch a train being handcuffed and cited for eating a breakfast sandwich on the station platform. 

In a now-viral video posted to Facebook Friday, a police officer is seen detaining a man who has since been identified as 31-year-old Steve Foster. Foster was heading to work around 8 a.m. on Nov. 4 when an officer stopped to tell him he was breaking the law by eating on the platform.

According to Bay Area Transit Authority (BART) General Manager Bob Powers, before the video starts, the officer asked the passenger not to eat and decided to move forward with a citation when he continued to do so. 

The video shows the officer holding onto Foster’s backpack as the two argue. “You are detained and you’re not free to go,” the officer says.

“You came up here and fucked with me,” Foster responds. “You singled me out, out of all these people.”

“You’re eating,” the officer says.

“Yeah, so what,” Foster responds.

“It’s against the law,” the officer says. “I tried to explain that to you. It’s a violation of California law. I have the right to detain you.”

The officer threatens to send Foster to jail for resisting arrest and eventually calls for backup. Foster’s friend, who filmed the encounter, tells the officer that there are no signs in the station that say passengers can’t eat on the platform. 

“Why is there a store downstairs selling food if we’re not allowed to eat up here?” she says. 

“Where is the sign up here that says we can’t eat on the platform? We know we can’t eat on the train.”  

Foster continues to eat and tell the officer he does this every morning. The officer continues to hold onto the backpack to detain Foster for refusing to give his name. Foster becomes more frustrated and throws profanities at him.

“You don’t get no pussy at home. I know you ain’t. When was the last time you got your dick sucked? I know it’s been a while,” Foster tells the officer before asking him to call his supervisor.

“I just missed two trains because of your fa**ot ass. You fucking fa*. Ask your momma what my name is,” he also tells the officer. 

“Show me a sign where it says I cant eat on the platform,” Foster says, but before the officer can respond he shouts in his face. “Shut up n***a. You ain’t got shit to say and now you feel stupid n***a…You nerd. You fucking nerd. Let my bag go.” 

After a few minutes, three other officers arrive and handcuff Foster before walking him down the platform and through the station. One of the officers then tells him he is being held because he matches the description of someone who was creating a disturbance on the platform. 

In a second video, the officer tells Foster’s friend he was initially responding to a report of a possibly intoxicated woman on the platform, whom he never found. That’s when he spotted Foster and let him know there is no eating on BART. He also tells the friend there are in fact signs that say there is no eating in the paid area of BART.

Foster was given a citation for the infraction and released after providing his name to the police. 

Reactions

After the footage circulated across social media, (in some cases, shorter edited clips) many users and BART riders expressed their frustration.

The incident even sparked protests and “eat ins” over the weekend, with more scheduled to continue. One Facebook event for this coming Saturday is called “Eat a McMuffin on BART: They Can’t Stop Us All.” 

According to BART Communications Director Alicia Trost, eating is prohibited in the “paid area” of the transit stations, meaning once passengers pass through the ticketing gate. The specific California law is PC 640 (b) (1): “Eating or drinking in or on a system facility or vehicle in areas where those activities are prohibited by that system.”

Though many social media users thought Foster was arrested for the incident, the BART spokesperson clarified that he was only issued a citation for eating. The spokesperson said Foster was “lawfully handcuffed when he refused to provide his identification,” and added that “the court will determine level of fine he should pay.”

Similar statements were provided on social media to users who had questions about the situation.

BART Apology 

In his Monday statement, General Manager Powers said, “As a transportation system, our concern with eating is related to the cleanliness of our stations and system.”

“This was not the case in the incident at Pleasant Hill station on Monday,” he continued. 

He noted that Foster, “refused to provide identification, cursed at and made homophobic slurs at the officer who remained calm through out the entire engagement,” but added that context of the situation was important. 

The officer was doing his job but context is key. Enforcement of infractions such as eating and drinking inside our paid area should not be used to prevent us from delivering on our mission to provide safe, reliable, and clean transportation. We have to read each situation and allow people to get where they are going on time and safely.”

“I’m disappointed [by] how the situation unfolded. I apologize to Mr. Foster, our riders, employees, and the public who have had an emotional reaction to the video,” he added.

In response to the statement, Foster told KGO–TV “I’m definitely upset, mad, a little frustrated, angry about it.”

“I hope they start focusing on stuff that actually matters like people shooting up dope, hopping the BART, people getting stabbed.” He also told other news outlets that he believes he was singled out because of his race and want the officer who cuffed him to be disciplined.

Foster said he is looking into his legal options as of now. According to Powers, the transit agency’s independent police auditor is investigating the incident.

See what others are saying: (Fox News) (NBC Bay Area) (CNN)

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ABC News Defends Its Epstein Coverage After Anchor Blasts the Network in Leaked Video

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  • In video leaked by Project Veritas, ABC anchor Amy Robach is seen criticizing the network for not airing a 2015 interview with one of Jeffrey Epstein’s most prominent accusers, Virginia Roberts Giuffre.
  • “She told me everything,” Robach said in the video. “She had pictures, she had everything. She was in hiding for 12 years. We convinced her to come out. We convinced her to talk to us. It was unbelievable what we had.”
  • Both ABC and Robach now say the network, at the time, could not corroborate the evidence presented in the interview but continued to investigate and report on Epstein.

Project Veritas Leak

ABC News is defending its decision to not air a 2015 interview with a prominent accuser of Jeffrey Epstein after a leaked video showed anchor Amy Robach blasting the network for the decision.

In the video leaked Tuesday by the right-wing activist group Project Veritas, Robach — caught on a hot mic — told an off-camera employee about how she had worked for three years to convince ABC to air the interview with Virginia Giuffre, then Virginia Roberts.

“She told me everything,” Robach said. “She had pictures, she had everything. She was in hiding for 12 years. We convinced her to come out. We convinced her to talk to us. It was unbelievable what we had: Clinton, we had everything. I tried for three years to get it on to no avail and now it’s all coming out and its like these new revelations and I freaking had all of it. I’m so pissed right now. Like, every day I get more and more pissed, ’cause I’m just like, ‘Oh my God! It was — what we had, was unreal.’”

The same year as her interview with ABC, Giuffre filed a civil lawsuit against Epstein claiming that he had held her as a teenage sex slave. She also claimed that, among other people, Epstein trafficked her to the United Kingdom’s Prince Andrew.

Following the accusation, both Prince Andrew and Buckingham Palace denied the claim, calling it “false” and “without foundation;” however, the two are known to have met at some point, with a photo showing Prince Andrew and a then-17-year-old Giuffre side-by-side. In the photo, the prince holds her midriff while she wears a crop top.

Source: Florida Southern District Court

In fact, in her castigation of ABC’s handling of the interview, Robach references the situation with Prince Andrew. 

“First of all, I was told, ‘Who was Jeffrey Epstein? No one knows who that is. This is a stupid story,’” she said. “Then the palace found out that we had her whole allegations about Prince Andrew and threatened us a million different ways. We were so afraid we wouldn’t be able to interview Kate and Will that we, that also quashed the story.”

The video was reportedly recorded in August, two days after NPR published a story where Giuffre told the outlet that she had spoken with ABC in 2015 but had never been told why the story didn’t air. She said, at the time, she had viewed the ABC interview as a “potential game-changer.”

“Appearing on ABC with its wide viewership would have been the first time for me to speak out against the government for basically looking the other way and to describe the anger and betrayal victims felt,” she told NPR.

Robach and ABC Exec Responds

By Tuesday evening, both ABC and Robach confirmed the footage to be real and explained why the interview never aired. According to Executive Vice President John Rouse, the network had been unable to corroborate the details of Giuffre’s claims, so it chose not to air the piece.

Notably, Rouse also said ABC never stopped investigating Epstein, which is true. The network has repeatedly published or aired stories regarding Epstein since Giuffree filed her lawsuit against him in 2015. Despite never broadcasting her interview, in July, Nightline aired an interview with two other alleged Epstein victims.

In another statement sent out by ABC, Robach backtracked from the comments she made in the leaked video.

“I was caught in a private moment of frustration,” she said. “I was upset that an important interview I had conducted with Virginia Roberts didn’t air.”

Like Rouse, she then said the interview did not meet ABC’s editorial standards. 

“My comments about Prince Andrew and her allegation that she had seen Bill Clinton on Epstein’s private island were in reference to what Virginia Roberts said in that interview in 2015,” she adds. “I was referencing her allegations — not what ABC News had verified through our reporting.”

“In the years since, no one ever told me or the team to stop reporting on Jeffrey Epstein, and we have continued to aggressively pursue this important story,” she ends the statement. 

Epstein’s Lawyer Calls ABC About the Interview

NPR’s August interview with Giuffe, however, also reveals another incident involving that 2015 interview. 

After receiving word that ABC had flown Giuffre to New York to interview her, one of Epstein’s top lawyers, Alan Dershowitz, reportedly called ABC to keep the network from going through with the story. Dershowitz said he believed he spoke with two producers and a lawyer.

“I did not want to see [Giuffre’s] credibility enhanced by ABC,” he told NPR. 

Along with Prince Andrew, Giuffre has alleged that Epstein trafficked her to Dershowitz, but he’s denied those claims.

Also in that article, unlike ABC, Julie Brown of the Miami Herald said she found Giuffre’s claims credible and went on to say there were other pieces of evidence that supported Giuffre’s story. Because of her reporting, Brown has been credited with helping to reopen and bring national attention to the Epstein case.

See what others are saying: (Axios) (Washington Post) (Page Six)

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