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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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Mother and Boyfriend Charged After Abandoning 3 Children in Apartment With Sibling’s Remains

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Authorities said the malnourished children had been living in the unit without their parents for months.


Abandoned Children Discovered in Houston

Police in Texas arrested a mother and her boyfriend on Tuesday after finding the woman’s three children abandoned in an apartment unit with the remains of their sibling.

Authorities found the 7-, 10-, and 15-year-old boys on Sunday when the teen called police to report that his brother had been dead for a year and that his body was in the unit.

When authorities arrived at the scene, they found the children living in “deplorable conditions.” Police also found the skeletal remains of an 8-year-old, who they emphasized had been decomposing for an extended period of time.

Harris County Sheriff Ed Gonzalez said the boys were fending for each other, with the eldest doing his best to care for the younger ones. According to the teen, his parents hadn’t been living in the apartment with them for months.

Gonzales called it one of the most shocking cases he had ever seen in all his years in law enforcement, and many are now asking how these kids could have been suffering for so long without anyone ever noticing.

Signs That Went Unnoticed

The Daily Beast reported that the kids hadn’t been attending school since May 2020, claiming that the school even conducted an unsuccessful home visit in September of that year.

On top of that, the children had been without power for several weeks, with one neighbor telling local reporters that the teen would often charge his phone at her place.

Another neighbor, Erica Chapman, said she had once found the teen sleeping on a playground slide, so she gave him some food and drinks.

I asked him if he was hungry. He said, ‘Yeah,’ and I brought him out some food and some drinks,” Chapman told KHOU.

She said he “wouldn’t talk about his parents,” and she didn’t push because she wanted him to feel safe coming to her if he needed food. Chapman added that she would drop off food at the apartment sometimes but said it was hard to tell what was going on inside.

Police also described a foul odor coming from the unit, which a different neighbor said she complained to management about more than once. That woman claimed the smell was so vile, she could not turn on her air conditioning.

Dianne Davis, who lived in the complex for two years, told The Houston Chronicle that the building manager performs regular inspections on the units, with the most recent one happening last week.

“How come they couldn’t detect this?” Davis told the paper. “How could that not have been found?”

Mother and Boyfriend Face Charges

According to Child Protective Services (CPS), the agency does have a history with the family, but there was no active investigation at the time the kids were discovered.

After they were found, the boys were treated at a hospital and placed with CPS while the agency seeks emergency custody of them.

At the hospital, doctors discovered fractures in the 7-year-old face and said two of the three boys were malnourished. Meanwhile, the medical examiner’s office said the deceased child suffered multiple blunt force injuries and ruled his death a homicide.

Police located the mother, 35-year-old Gloria Williams, and her boyfriend, 31-year-old Brian Coulter, on Sunday. They were interviewed and initially released without charges.

ABC13 reported that the teen texted his mother, who lived just 15 minutes, before calling the police.

On Tuesday, the couple was finally arrested while allegedly reading articles about themselves at a library. Williams, faces multiple charges, including injury to a child by omission and tampering with evidence involving a human corpse.

Meanwhile, Coulter was charged with murder over the death of the child, though both he and Williams are expected to face more charges as investigators continue to unpack the details of this case.

See what others are saying: (The Houston Chronicle) (The Daily Beast) (The Washington Post)

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Man Spent COVID Relief Loan on $58,000 Pokemon Card, Feds Say

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The man is facing a wire fraud charge, which carries a max sentence of up to 20 years in federal prison, along with a $250,000 fine.


COVID Relief Funds Used on Pokemon Card

Authorities have accused a man in Georgia of misusing COVID-19 relief funds, claiming that he spent $57,789 on a single Pokemon card.

Prosecutors said Vinath Oudomsine made false statements about the gross revenue his business earns and the number of workers he employs when he applied for aid authorized under the CARES Act.

On his July 2020 application, Oudomsine allegedly claimed he had 10 employees and 12-month gross revenues of $235,000.

The following month, he was given about $85,000 from the Small Business Administration (SBA), which means he spent nearly all of the money on the rare card.

Authorities have given few details about the specific card purchased, though they have said Oudomsine was charged with wire fraud and is expected to appear in court on Thursday.

The charge carries a max sentence of up to 20 years in federal prison, along with a $250,000 fine.

Misuse of COVID Relief Funds

Oudomsine is far from the first person to face charges for fraud related to small business loans issued amid the pandemic. Others who received relief funds have been accused of spending the money on Lamborghinis, nights at strip clubs, and even an alpaca farm, among other purchases.

In fact, the first person to be charged with fraudulently seeking a pandemic relief loan was recently sentenced to 56 months in prison following a nationwide search after the man faked his own death.

According to The Washington Post, a federal watchdog said this month that the SBA overpaid $4.5 billion in grants to self-employed people and that “no system of controls was in place to flag applications with flawed or illogical information.”

On top of that, the SBA inspector general determined earlier this year that the agency rushed to send out billions of dollars in loans through the Paycheck Protection Program (PPP) “at the expense of controls” that could have blocked inappropriate aid.

In a statement on Sunday, the agency said that under the Biden administration, it has worked with Congress and the inspector general to add antifraud measures. Meanwhile, defenders of pandemic relief programs have argued that flagged loans and grants represent only a small fraction of the distributed aid that has been critical to small businesses and their pandemic recovery.

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

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FDA Authorizes Moderna and J&J COVID Vaccine Boosters, Approves Mix-and-Match Doses

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The approval will allow at-risk Americans who received Pfizer and Moderna vaccines to get any booster six months after their initial series and all Johnson & Johnson recipients 18 and older to do the same two months after their single-shot dose.


New FDA Authorization

The U.S. Food and Drug Administration (FDA) on Wednesday authorized boosters shots of Moderna and Johnson & Johnson COVID-19 vaccines and approved a mix-and-match strategy that will allow people who got one company’s shot to get a booster from a different maker.

The decision paves the way for millions of more at-risk Americans to get extra protection, and not just certain Pfizer recipients as previously approved by the FDA.

Under the authorization, people who received Moderna or Pfizer can get any one of the three booster shots six months after completing their initial series if they are 65 and older, at high risk of severe COVID, or face increased exposure because of their work.

Meanwhile, all J&J recipients 18 and older can get any of the approved vaccines two months after they received the one-shot jab.

Hazy Recommendations, For Now

Notably, the FDA did not recommend a certain combination of vaccines, nor did the agency say whether or not it would be more effective for people to stick with their original vaccine maker for their booster.

The new authorizations draw on a study from the National Institutes of Health (NIH), which found that there are no safety concerns with mixing boosters and that vaccine combinations were at least as effective in stimulating antibodies as matched vaccines.

In the case of J&J recipients, the NIH found that people actually had a higher boost from mixing either Moderna or Pfizer boosters.

However, some of the scientists who worked on the study said it should not be used to recommend one combination over another because the research was limited.

The Centers for Disease Control and Prevention (CDC), which determines vaccine recommendations, could issue more guidance on when and whether people should switch vaccine makers for their booster shots.

An advisory panel for the agency is meeting Thursday to discuss the new FDA authorizations and recommendations.

Once the panel makes its decision, the CDC director has the final say on the guidelines. If the agency agrees with the FDA’s decisions, the booster shots could be rolled out as soon as this weekend.

See what others are saying: (The New York Times) (NPR) (The Washington Post)

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