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Women sounded alarm on Essure birth control device. Now the FDA is cracking down.



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Nine years ago, Angie Firmalino was implanted with a permanent contraceptive device called Essure. The procedure, she says, was “extremely painful,” and the discomfort she felt even months later — fevers, achy joints, constant bleeding — was nearly debilitating.

Firmalino eventually took her concerns to a doctor, who did an ultrasound and discovered that the implant, originally inserted in her fallopian tubes, had become dislodged and migrated to her uterus.

 Angie Firmalino during a 2017 hospital visit she says was related to complications from her Essure implant. Courtesy Angie Firmalino

She was shocked. After the appointment, “I sat in my car and cried,” Firmalino, 45, of Tannersville, New York, said in a telephone interview on Tuesday.

Firmalino later had the device removed, but that procedure left behind metal fragments that ravaged her reproductive system. She was alarmed that other women, unaware of the potential dangers, were still receiving the Essure implant. She started a Facebook group called Essure Problems to warn her friends and family about the device, and the group is now a forum for more than 36,000 women, some of whom say doctors, regulators and Essure’s maker have not taken their concerns seriously.

But finally, Firmalino and many of her fellow advocates were encouraged this week when the Food and Drug Administration said it would restrict the sale and distribution of Essure.

“We have been banging on the door with information and data, begging and pleading with them to do something,” Firmalino said of the FDA.

 Bayer’s birth control implant Essure. Bayer / via AP file

Essure consists of two sets of small metal coils that are inserted through the vagina and cervix into the fallopian tubes. The coils are meant to cause inflammation, building up scar tissue that blocks the tubes and stops eggs from being carried from the ovaries to the uterus.

The FDA said Monday that over 15 years — Nov. 4, 2002, when Essure was approved, through December 2017 — it received 26,773 reports of problems, including pain, heavier periods and irregular bleeding, headaches and fatigue. Patients also reported that the device had become dislodged or had broken. And the agency has received reports of eight adult deaths related to Essure.

In its announcement on Monday, the FDA said Bayer, the manufacturer of Essure, can sell the device only to health care providers and facilities that guarantee women have been fully informed about its potential side effects.

Doctors must review with patients a checklist of the side effects, and both are required to sign it. (Two years ago, the FDA ordered Bayer to place a “black box” warning on the product package, but doctor-patient discussions were not mandatory at the time.)

FDA Commissioner Scott Gottlieb, who met with a group of Essure critics earlier this year, said in a statement that his agency is taking action because “despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information.”

 Scott Gottlieb appears at his confirmation hearing before the Senate Committee on Health, Education, Labor, and Pensions, on Capitol Hill in Washington on April 5, 2017. J. Scott Applewhite / AP file

“That is simply unacceptable,” Gottlieb added. “Every single woman receiving this device should fully understand the associated risks.”

Amanda Edwards Rusmisell, 45, of Charlotte, North Carolina, who says the pain from her Essure implant was so intense she would often cry in her sleep, hailed the FDA decision.

“We were ecstatic,” said Edwards Rusmisell, a recruiter and an administrator of the Essure Problems group. “We finally felt like somebody was listening.”

The FDA stopped short of outright banning Essure, though many patients would like the device taken off the medical market altogether. That would be be a rare move: The agency has only banned two medical devices: prosthetic hair fibers and powdered gloves.

Holly Ennis, a lawyer who said she represents close to 1,000 women who have filed lawsuits against Bayer over Essure, sees the FDA action as “a huge step in the right direction.”

“The requirements are so tight that they will effectively sound the death knell for the device,” Ennis said. “Doctors will realize it is just not worth the burden and the risk.”

In a statement, Bayer said the “benefit/risk profile of Essure has not changed and remains positive.”

“Bayer has educated and continues to educate health care providers about the importance of appropriately counseling each patient on the benefits and risks of Essure,” the German multinational said. “The FDA requested we update the label to emphasize this point.”

More than 750,000 Essure devices have been sold worldwide since it was introduced in 2002, according to Bayer. The product, long presented as a less invasive alternative to surgical sterilization, is no longer sold outside the U.S. for “commercial reasons,” company spokeswoman Courtney Mallon said in an email. She said that decision was not related to product safety.

“Essure critics regularly attempt to paint that picture, which leads to broad dissemination of misleading and inaccurate information on social media that is directly influencing women’s choices,” Mallon said.

In the last two years, since a stronger warning was added to the box, there has been a roughly 70 percent decline in the sales of Essure in the United States, the FDA said.

Lisa Saenz, 49, a social worker who lives in New York City, received an Essure implant in 2008. She later experienced so many problems — hair loss, fatigue, stabbing pains in her side, blood clotting — that at one point, she said to herself, “I feel like I’m dying.” The coils had perforated her uterus, and she needed an operation to remove them.

In the future, she hopes Essure will no longer be sold at all.

“We don’t want this offered as an option to any woman,” Saenz said. “Hopefully we see the end of this awful product soon.”

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Biden inauguration: Former FBI boss James Comey warns of serious threat from ‘armed, disturbed people’ | US News



Former FBI boss James Comey has told Sky News he is worried about the threat of violence from “armed, disturbed people” at Joe Biden’s inauguration.

Mr Comey, who was controversially fired by Donald Trump in 2017, says the threat has “to be taken very, very seriously” following the deadly Capitol riots.

The new US president will be sworn in on Wednesday amid high security after the FBI identified more than 200 people threatening violence in “concerning online chatter”.

Security has been ramped up at the Capitol building ahead of Joe Biden's inauguration
Security has been ramped up at the Capitol building ahead of the inauguration

Fuelled by unsubstantiated claims by Mr Trump, many of his supporters believe there was fraud in November’s election.

“I’m worried because there are armed, disturbed people who are in this state of mind where they believe their country is being taken from them,” said Mr Comey.

“So it’s a threat law enforcement in the States has to take very seriously.

“At the same time, I know that we have the capability, investigative and the tactical capability on scene, to protect these locations and so I am optimistic that the threat will be neutralised, but it has to be taken very, very seriously.”

On Friday a man was arrested in Washington DC when a gun and hundreds of rounds of ammunition was found in his vehicle after he allegedly showed police an unauthorised inauguration credential.

Wesley Allen Beeler, from Virginia, has been charged with carrying a concealed weapon, possessing an unregistered firearm, unlawful possession of ammunition and possession of a large capacity ammunition feeding device, police told NBC News in Washington.

The National Guard has been descending on Washington to guard government buildings ahead of inauguration day, when officials say 21,000 will be on hand.

The storming of the Capitol building – the heart of US democracy – on 6 January caused widespread shock in America and across the world, with Trump supporters running amok and leaving five people dead.

Police were hugely outnumbered and have been criticised over how easy it was for the rioters to seize control.

Mr Comey told Sky News he was “sickened” by the violence and angry at the failure to defend the building, despite the obvious threat.

Several National Guard members are pictured lying on the floor of the U.S. Capitol
Some 21,000 members of the National Guard will be in Washington for the big day

“I was angered by the apparent failure to defend a hill, it [the Capitol] sits on a hill with 2,000 officers assigned to it on a daily basis, the failure to defend the hill. It just mystifies and angers me,” he said.

“It is going to be important for our country to understand that failure.”

He added: “9/11 we were told was a failure of imagination, we didn’t anticipate the way the terrorists might come at us; this didn’t require imagination.

Donald Trump supporters storm the US Capitol
Mr Comey says law enforcement should have seen the riot coming

“This was all over the internet and the group literally walked slowly down Pennsylvania Avenue towards the Capitol so it was just a failure and we need to know why at all levels so that we don’t let it happen again.”

Mr Comey is a fierce critic of Mr Trump – who he has previously compared to a mafia boss.

He was fired by the president in May 2017 while the FBI was investigating Russian meddling in the 2016 presidential election.

James Comey and Donald Trump shake hands
Donald Trump controversially fired Mr Comey as FBI director in May 2017

White House officials accused him of mishandling the investigation into the email practices of Hillary Clinton, but Mr Trump later confirmed the “Russia thing” was on his mind when he made the decision.

Mr Comey, 60, has just released a new book called Saving Justice: Truth, Transparency, and Trust, described as a “clarion call for a return to fairness and equity in the law”.

The disgust among many Americans over the Capitol riots this week led Mr Trump to become the first president to be impeached twice after the House of Representatives charged him with inciting the riot.

No date has been set for the political trial that follows, where senators can also vote by a simple majority to block Mr Trump from ever standing for election again.

You can watch the full interview on Sophy Ridge on Sunday from 8.30am.

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‘Very special moment’ as Nepali sherpas are the first to reach top of K2 in winter | World News



A team of Nepalese sherpas has made history by scaling the world’s second-highest peak during the winter season.

The 10 climbers reached the summit of Pakistan’s K2 on Saturday, more than 20 years after the first winter attempt to reach the 8,611m summit.

The secretary of Pakistan’s Alpine Club, Karrar Haideri, said four international teams had arrived about a month ago to scale the mountain but the Nepalis were the only ones to succeed so far.

He said that the sherpas had been spread across different teams but had formed a new group so they could claim the historic feat for their country.

Previously nobody had managed to get higher than 7,750m in the winter – a record set almost two decades ago – but on Saturday the weather conditions were fair enough for the team to push ahead.

The group comprised Nirmal Purja, Gelje Sherpa, Mingma David Sherpa, Mingma G, Sona Sherpa, Mingma Tenzi Sherpa, Pem Chhiri Sherpa, Dawa Temba Sherpa, Kili Pemba Sherpa, and Dawa Tenjing Sherpa.

Mr Purja said in an Instagram post that the moment the group reached the top of the mountain was “very special”.

“The whole team waited 10m below the summit to form a group then stepped onto the summit together while singing our Nepalese national anthem.

“We are proud to have been a part of history for humankind and to show that collaboration, teamwork and a positive mental attitude can push limits to what we feel might be possible.”

K2 is on the Pakistan-China border and during the winter, winds on K2 can reach more than 125mph and temperatures can drop as low as -60C (-76F).

The mountain was first climbed in 1954 by Italian Achille Compagnoni and he is among only 367 people to have completed the ascent. Some 86 people have died trying.

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Uganda presidential election: Incumbent Yoweri Museveni declared winner | World News



Yoweri Museveni has been declared the winner of the Uganda presidential election with 58.64% of the total votes, according to the country’s electoral commission.

The incumbent will now serve a sixth term as president of the east African nation following some of the worst pre-election violence since the 76-year-old took office in 1986.

His man opposition, singer Bobi Wine, has alleged vote rigging throughout the process and had strong support in urban centres where frustration with unemployment and corruption remains high. He won 3.48 million votes, or 34.8% of the total, according to the commission.

Bobi Wine's trademark red beret has become a symbol of opposition to longtime President Yoweri Museveni.
Opposition candidate Bobi Wine was assaulted and arrested several times during the election campaign

Mr Wine and other opposition candidates were often harassed, and more than 50 people were killed when security forces halted riots in November after he was arrested.

Although Mr Museveni holds on to power, at least 15 of his cabinet ministers including the vice president were voted out, with many losing to candidate’s from Mr Wine’s party, according to local media.

Mr Wine, real name Kyagulanyi Ssentamu, claimed victory on Friday and said he had video evidence of vote-rigging and insisting “every legal option is on the table” to challenge the election results.

He was beaten up and arrested several times during the election campaign but was never convicted of any charge. He later wore a flak jacket and said he feared for his life.

On Saturday, Mr Wine said his home in the capital Kampala had been surrounded by soldiers and the military was now allowing him to leave.

The army’s deputy spokesman, Deo Akiiki, told Reuters security officers were assessing threats to Mr Wine if left his home.

Monitoring of the elections has been hit by the arrest of independent observers and the denial of accreditation for members of the UN observer mission.

Tibor Nagy, the top US diplomat for Africa, tweeted on Saturday that “Uganda’s electoral process has been fundamentally flawed”, adding that the “US response hinges on what the Ugandan government does now”.

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