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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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Ohio Will Give 5 People $1 Million for Getting Vaccinated

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  • Ohio is launching a lottery program that will give five people ages 18 or older $1 million each if they receive at least one dose of a COVID-19 vaccine.
  • Five vaccinated people between 12 and 17 years old will win full four-year scholarships to one of the state’s public universities under a similar giveaway program. 
  • Some have criticized the move as a waste and misuse of federal coronavirus relief funds, but others applauded it as a strong effort to boost slumping vaccination rates.
  • Gov. Mike DeWine (R) addressed critics on Twitter, writing, “The real waste at this point in the pandemic — when the vaccine is readily available to anyone who wants it — is a life lost to COVID-19.”

Ohio Announces Vaccine Lottery

Several states and cities across the country have been rolling out different incentives to help boost COVID-19 vaccination rates. Some are offering $100 savings bonds, $50 prepaid cards, and even free alcohol, but Ohio’s Republican Gov. Mike DeWine took it a step further Wednesday, saying that five people in his state will each win $1 million for getting vaccinated.

DeWine said that the lottery program, named “Ohio Vax-a-Million,” will be open to residents 18 and older who receive at least one dose. Drawings start May 26 and winners will be pulled from the state’s voter registration database.

The Ohio Lottery will conduct the drawings, but the money will come from existing federal coronavirus relief funds.

Younger people will also have a chance to win something. That’s because DeWine said five vaccinated people between 12 and 17 years old will be eligible to win a full four-year scholarship to one of the state’s public universities under a similar lottery program. The portal to sign up for that opens May 18.

DeWine Defends Lottery

Reactions to the giveaway have been mixed. Some echoed statements from State Rep. Emilia Sykes, the top House Democrat, who said, “Using millions of dollars in relief funds in a drawing is a grave misuse of money that could be going to respond to this ongoing crisis.”

DeWine, however, seems to have anticipated pushback like this.

“I know that some may say, ‘DeWine, you’re crazy! This million-dollar drawing idea of yours is a waste of money,'” he tweeted. “But truly, the real waste at this point in the pandemic — when the vaccine is readily available to anyone who wants it — is a life lost to COVID-19.”

Despite some backlash, a ton of other people have applauded the plan as a smart way to encourage vaccinations across all age groups. So far, about 36%of Ohio’s population has been fully vaccinated — compared with 35% nationally. 

Still, the number of people seeking vaccines has dropped in recent weeks, with an average of about 16,500 starting the process last week, which is down from figures above 80,000 in April. 

See what others are saying: (AP News) (NPR)(The New York Times)

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Derek Chauvin Qualifies for Longer Sentence Over George Floyd’s Murder, Judge Rules

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  • A judge overseeing the trial of Derek Chauvin ruled Wednesday that there were enough aggravating factors in the former officer’s murder of George Floyd that could qualify him for a longer prison sentence.
  • While Chauvin was found guilty on all three charges he faced, Minnesota state law only allows him to receive prison time for the most serious charge of second-degree homicide, which has a max sentence of 40 years but a recommended sentence of 12.5 years for people with no criminal history.
  • The judge ultimately agreed that Chauvin qualifies for longer sentencing because prosecutors had proven that he abused his power as a police officer, acted “particularly cruel” to Floyd, and committed the crime in front of children with at least three other people.
  • Chauvin is currently scheduled to be sentenced on June 25.

Judge Cahill Rules on Aggravating Factors

Hennepin County District Judge Peter Cahill, who oversaw the murder trial of Derek Chauvin, has ruled that there were aggravating factors in the former Minneapolis police officer’s murder of George Floyd, thus qualifying him for a longer sentence.

While the jury found Chauvin guilty on all three charges he was facing, Minnesota law says that he will only face sentencing for the most serious charge, which in this case is second-degree murder.

That charge carries a maximum sentence of 40 years, but state sentencing guidelines recommend 12 and a half years for someone with no criminal history. Prosecutors asked Judge Cahill for what’s called an “upward sentencing departure,” arguing that there were five factors that should open Chauvin up to a maximum sentence.

In a ruling made public Wednesday, Cahill wrote that prosecutors had proved beyond a reasonable doubt four of those five factors.

In his decision, Cahill agreed with the prosecutor’s claim that Chauvin had “abused his position of trust and authority” as a police officer and that he “knew from his training and experience” that the neck restraint he used Floyd in “danger of positional asphyxia.” 

Cahill also supported the argument that the former officer had been “particularly cruel” to Floyd, who he wrote “was begging for his life and obviously terrified by the knowledge he was likely to die,” adding that Chauvin “remained indifferent to Mr. Floyd’s pleas.”

The third and fourth aggravating factors that the judge sided with prosecutors on were that Chauvin had committed the crime as part of a group of three or more people and that he perpetrated that crime in front of children.

Notably, Cahill did reject the fifth aggravating factor brought by prosecutors, who argued Floyd was “particularly vulnerable” because he was handcuffed and held facedown on the street. The judge said that prosecutors did not prove that argument, writing that Floyd had been able to resist arrest before he was put on the ground.

Additional Charges

The ruling comes just a few days after Chauvin and the three other officers were indicted on federal civil rights charges by a grand jury.

Chauvin was also indicted on a second, separate federal charge related to the arrest of a 14-year-old boy in September 2017, during which he allegedly held the boy by the neck and hit him with a flashlight repeatedly.

According to reports, if he is convicted, he would likely serve the federal sentence at the same time as his state one. However, the federal charges may impact the pending August trial of the three other officers, who have been charged with aiding and abetting murder and manslaughter.

Separately, last week, Chauvin’s defense attorney filed a motion for a new trial, alleging misconduct by the judge, prosecutors, and jurors, signaling additional continued litigation.

See what others are saying: (The Washington Post) (NPR) (CNN)

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Teens Attack and Rob 80-Year-Old Asian Man in Northern California

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  • Viral surveillance footage shows an 80-year-old Asian man in the San Francisco Bay area being assaulted and robbed on Saturday by suspects who police say are teenagers.
  • Police believe the suspects are as young as 16, and at one point, one can be heard in the video giggling from the getaway car as the victim cries for help. 
  • The news comes after the nonprofit Stop AAPI Hate released data showing that reports of anti-Asian hate incidents in the U.S. jumped by almost 74% year-over-year in March.

Suspect Laughs at Victim During Attack

Surveillance video going viral on social media captured an 80-year-old Asian man in the San Francisco Bay area getting assaulted and robbed on Saturday by suspects who police believe are teenagers.

The full video is extremely distressing. It shows the man getting knocked to the ground, trying to fight off his attackers as he cries for help. To make matters worse, at one point, high-pitched giggles can be heard coming from another teen in the background. That person appears to be inside a getaway car nearby.

The victim was robbed of a watch and sustained minor injuries. Police have also said that a vehicle similar to the one used in this case was spotted at a strong-armed robbery in a nearby San Leandro area less than two hours later, where another victim was robbed of her purse.

Police believe the suspects are as young as 16.

Surge of Crimes Against Asians in U.S.

This is just the latest violent attack against an Asian person making headlines since the start of the coronavirus pandemic.

Last week, reports emerged regarding two Asian women who were attacked with a hammer in Times Square by someone demanding they remove their masks. Two other Asian women were recently stabbed while waiting for the bus in downtown San Francisco.

The San Francisco-based nonprofit Stop AAPI Hate released data Thursday saying that reports of anti-Asian hate incidents in the U.S. jumped by almost 74% year-over-year in March — with Chinese people as victims in 44% of these acts.

Vancouver Sees Massive Influx of Anti-Asian Hate

While anti-Asian hate crimes have surged in the U.S., the situation may be worse in Canada, specifically in Vancouver. Around 42% of people in Vancouver are of Asian descent and at least 25% speak Chinese — making it the most heavily Asian city in North America.

Still, it witnessed a 717% year-over-year surge in anti-Asian hate crimes in 2020, according to the Vancouver Police Department. Bloomberg even dubbed it the Anti-Asian hate crime capital of North America, saying more anti-Asian hate crimes were reported in the city of 700,000 people last year than in the 10 largest U.S. cities combined.

That’s part of why people all across the city are participating in more organized action to speak out against anti-Asian hate. For instance, several rallies took place in Vancouver Monday to mark the National Day of Action Against Anti-Asian Racism.

See what others are saying: (ABC 7) (Bloomberg) (Forbes)

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