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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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Tik Tok “Skull Breaker” Challenge Leading to Severe Injuries

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  • Tik Tok has seen a new viral challenge that involves a person getting tricked into jumping into the air while two others kick their legs out from under them, causing them to fall onto the ground.
  • Multiple young people have suffered injuries as a result of the challenge, and it has been reported that one Brazilian teenager died.  
  • Concerned parents are striving to raise awareness of the dangers of the trend, and one student even started a non-profit organization to combat pranking and bullying after falling victim to the challenge herself.

Dangerous Online Trend

A new trend is making its rounds on the popular app Tik Tok— one that has led to serious injuries and received backlash from concerned parents.   

The “skull breaker” challenge involves three people standing in a line, shoulder to shoulder, under the pretense that all of them will jump into the air at the same time. But instead, only the middle person jumps while the two people flanking them kick their legs out from under them, causing them to slam into the ground. In most cases it appears that the middle person is tricked into the challenge, unaware that they will be knocked over.

The danger of the “skull breaker” challenge can be found in its name, as it quite literally has the potential to crack people’s heads open. Doctors are warning that it can result in broken bones, concussions, and brain bleeding, among other injuries. 

Tik Tok has expressed their disapproval of the challenge. The app told ABC News that the safety of their users is a top priority and they “do not allow content that encourages or replicates dangerous challenges that might lead to injury.”

Awareness Growing 

This new online fad is the latest dangerous trend among young people, akin to the Tide Pod challenge and the viral Tik Tok “outlet challenge” that prompted warnings from fire officials. A Brazilian teenager reportedly died from the “skull breaker” challenge, and more youth around the world have been seriously hurt.  

The recent virtual trend raised eyebrows in Daytona Beach, Florida in January, when two students convinced an unsuspecting third female student to perform the challenge for Tik Tok content. 

According to the Daytona Beach News Journal, the video has since been deleted. The News Journal reported that the victim’s parents were originally going to let the school handle it but ultimately decided to press charges. The Daytona Beach Police Department told TODAY that two students are facing misdemeanor charges of battery and cyberbullying as a result of the prank.    

On Feb. 8, an Arizona woman posted images of her injured son to Facebook, reporting a head injury as well as stitches and cuts to his face that stemmed from the skull breaker challenge.

“My son was asked to do a jumping contest with his 2 ‘friends,’ when he jumped up, the 2 boys kicked him, as hard as they could, so his legs flew out in front of him,” Valerie Hodson wrote. “He landed hard flat on his back and head, as he struggled to get up he lost consciousness, he fell forward landing on his face.”

“I really contemplated posting this, but I feel there needs to be awareness of this malicious cruel viral prank,” Hodson said.

Facebook: Valerie Hodson

Hodson’s son is not the only child to be hospitalized due to the skull breaker challenge. Teri Smith, a woman located in Alabama, also took to Facebook to discuss her son’s broken bones after falling victim to the prank.

“Prayers needed… Parker was unknowingly tiktok pranked which caused him to fall,” Smith wrote. 

Facebook: Teri Wimmer Smith

Similar pushes for awareness have been seen as impacts of the challenge have been felt by others around the country. In Portland, Oregon, 14-year-old Olivia Ross said she hit her head hard on the ground after she was tricked into the challenge by two seniors at her high school. 

“They just told me we were going to jump for a video. Of course I was excited since they were upperclassmen and they were asking me to be in their video,” Ross told KOIN 6. “But I didn’t know what was going to happen.”

Ross and her mother, Lindsay Zobrist, decided the best course of action was to spread awareness of these types of viral pranks because they expect that many kids don’t know how dangerous they can be. They created a non-profit organization called Teaching Kindness Matters and are working to get school districts to include “pranking” in their definition of bullying. 

See what others are saying: (TODAY) (Forbes) (ABC13)

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Trump Slams Oscars for Awarding South Korean Film Best Picture

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  • At a Colorado rally on Feb. 20, President Donald Trump bashed the Oscars for giving this year’s Best Picture award to “Parasite,” a South Korean film. 
  • He instead called for movies like “Gone With the Wind” to return, a production that has been criticized for romanticizing slavery. 
  • Additionally, Trump called Brad Pitt a “little wise guy” for making a joke about the president’s impeachment trial during his Oscars acceptance speech.
  • In response to his remarks, the U.S. distributor of “Parasite,” dissed the president for not being able to read the film’s subtitles. 
  • Others also gave Trump backlash for not liking the film because it revolves around a struggling Asian working-class family.

Oscars Jab

At a rally in Colorado on Thursday, President Donald Trump took a dig at the 2020 Oscars for awarding Best Picture to the South Korean film “Parasite.” 

“By the way, how bad were the Academy Awards this year?” Trump asked the crowd in Colorado Springs, who responded with boos. 

“And the winner is a movie from South Korea, what the hell was that all about?” Trump asked. “We got enough problems with South Korea with trade. On top of it, they give them the best movie of the year.”

Despite his criticisms, Trump went on to imply that he didn’t even watch the film. 

“Was it good? I don’t know,” he said. 

Credit: CBS News

“Parasite” made history earlier this month when it became the first film in a non-English language to win the Academy Award for Best Picture. On top of that, the movie took home awards for Best Original Screenplay, Best International Language Film, and Best Director—Bong Joon Ho.  

These accomplishments didn’t seem to impress the president. Instead, he called for movies like “Gone With the Wind” and “Sunset Boulevard” to return. Both films feature white stars and were directed by white men. 

Released in 1939, “Gone With the Wind” centers around a plantation-owning family in 1861. Accounting for inflation, it still holds the record for the highest-grossing film in U.S. history. But in recent years, the film has largely gone from a revered American classic to a piece of work examined and criticized for its romanticism of slavery. 

Also at Thursday’s rally, Trump slammed Brad Pitt, who made a joke about the president’s impeachment trial during his Oscars acceptance speech for Best Supporting Actor.

“They told me I only have 45 seconds up here, which is 45 seconds more than the Senate gave John Bolton this week,” Pitt said at the awards show on Feb. 9. 

The “Once Upon A Time in…Hollywood” star was referring to the former national security advisor who had not been allowed to testify in the impeachment trial. 

“And then you have Brad Pitt. I was never a big fan of his. He got up, said a little wise guy statement. Little wise guy. He’s a little wise guy,” Trump said on Thursday.  

Clap Backs Against POTUS

The president’s critiques of the Academy Awards did not go unnoticed. Though “Parasite” is in Korean, it’s accompanied by English subtitles. Neon, the film’s U.S. distributor, responded to Trump’s remarks in a biting tweet. 

“Understandable, he can’t read,” the company said in their reactions to Trump’s dislike of the movie.

Neon added the hashtag #Bong2020 in reference to the film’s director.

The Democratic National Committee also weighed in, adding their own diss to the president. 

“Parasite is a foreign movie about how oblivious the ultra-rich are about the struggles of the working class, and it requires two hours of reading subtitles. Of course Trump hates it.”

Other Twitter users chimed in with similar messages condemning the president. 

“Anyway parasite is still the best movie of the year Trump’s racist ass can cry about it,” one person said.

See what others are saying: (NBC) (Washington Post) (The Hill)

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UCLA Drops Controversial Facial Recognition Plan

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  • After backlash from students and activist groups, UCLA is dropping its plans to use facial recognition on campus.
  • Critics said the software often fails when recognizing women and people of color, and could lead to racial profiling. 
  • UCLA released a statement, just over a week before a National Day of Action to Ban Facial Recognition from College Campuses is set to be held, saying that the school longer thinks the technology would be effective at the school.
  • The use of facial recognition software on college campuses and on a national level has long been a subject of debate. Several cities have already banned it, and last week, two Senators proposed legislation banning it on a federal level unless Congressional guidelines are enacted. 

UCLA Stops Plans to Use Facial Recognition

After backlash from students and activists, the University of California, Los Angeles has dropped its plans to use facial recognition technology on its campus.

UCLA announced plans to potentially use it in its security systems. Students were concerned that this technology could interfere with students’ privacy and lead to racial profiling on campus. 

“We have determined that the potential benefits are limited and are vastly outweighed by the concerns of the campus community,” Michael Beck, the Administrative Vice-Chancellor of the school said in a statement to Fight for the Future, a group advocating for freedom in the digital age.

Fight for the Future is holding a National Day of Action to Ban Facial Recognition from College Campuses on March 2. The group had been very vocal when encouraging UCLA not to adopt facial recognition. They did a test on how effective it would be at the school and found racial biases in its algorithm.

Inaccuracies in Facial Recognition

Fight for the Future used Rekognition, a software made available by Amazon, and scanned publicly available photos of UCLA athletes and faculty and compared them to a mugshot database. They scanned 400 faces in total and said that 58 were falsely matched. 

“The vast majority of incorrect matches were of people of color,” Fight for the Future said of their findings. “In many cases, the software matched two individuals who had almost nothing in common beyond their race, and claimed they were the same person with ‘100% confidence.’”

They are not the only group to find this. According to a study from the National Institute of Standards and Technology, in terms of one-to-one matching, there are higher rates of false positives for Asian and African American faces in comparison to white faces. They specifically noticed increased false positives when it came to African American females.

Student Concerns

Students at UCLA expressed their concerns about this. An editorial in the school’s paper, the Daily Bruin, warned against using facial recognition because of the potential inaccuracies and profiling of people of color.

“For students belonging to these groups, facial recognition technology would simply reinforce the biases that are already stacked against them,” the piece said. The editorial listed privacy as a concern as well.

“Facial recognition technology would present a major breach of students’ privacy and make students feel unsafe on a campus they are supposed to call home,” the Daily Bruin editorial staff wrote. “It is one thing to monitor campus activity with security cameras, but it’s another entirely to automatically identify individuals and track their every move on campus.”

Students and advocacy groups like Fight for the Future were pleased with UCLA’s ultimate decision to not use facial recognition.

“Let this be a lesson to other school administrators: if you try to experiment on your campus with racist, invasive surveillance technology, we will come for you. And we don’t lose,” Deputy Director of Fight for the Future, Evan Greer, said in a statement.

Facial Recognition on a National Scale

UCLA is not the only college in the United States having a conversation about facial recognition. Fight for the Future has been keeping a scorecard of schools that have stated their intentions on using facial recognition. While big schools like Harvard, MIT, Michigan State, and NYU have said they do not intend on using it, other major colleges like Ohio State, Princeton, and the University of Georgia have stated that they might. 

Outside of colleges, other localities have already been working on fighting against facial recognition technology. In 2019, San Francisco became the first U.S. city to ban facial recognition technology. Somerville, MA, Oakland, CA and Berkeley, CA did the same months later. 

Still, this kind of technology is still used on a wide scale. According to Vox, in states like Texas, Florida, and Illinois, the FBI uses it to scan through DMV databases. In many U.S. airports, Customs and Border Protection uses it for screening passengers on international flights. 

Recently Proposed Legislation

The national use of this could be subject to change, though. In February, Senators Jeff Merkley (D-)R) and Cory Booker (D-NJ) proposed legislation that would ban federal use of facial recognition until proper regulations and rules had been established by Congress for it.

“Facial recognition is a technology that is increasingly being used and marketed to law enforcement agencies across the United States without appropriate debate or consideration of its impacts,” the bill said before describing that this technology has been used at protests, rallies, and other events where one’s’ freedom of speech is on display.

“It is critical that facial recognition not be used to suppress First Amendment related activities, violate privacy, or otherwise adversely impact individuals’ civil rights and civil liberties,” the legislation continued. 

This legislation would still allow law enforcement to use it if given a court order.

See what others are saying: (Vice) (USA Today) (TechCrunch)

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