Health Care

FDA restricts sale of Bayer's Essure birth control device

FDA restricts sale of Bayer's Essure birth control device

The U.S. Food and Drug Administration (FDA) has restricted the sale of Bayer AG's implanted birth control device Essure, the agency said https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604098.htm on Monday, arguing that some women were not properly informed about risks related to the device. The FDA is taking this step after becoming aware that some women were not being adequately informed of Essure's risks before getting the device implanted, despite previous significant efforts to educate patients and doctors about the risks associated with this device.

"Patients deserve the most accurate and comprehensive information to help them make their health-care decisions, and 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 company said in a statement.

According to the FDA, Essure sales dropped 70 percent in 2016 after they required Bayer to include a warning and checklist.

Since then, USA sales of Essure have fallen 70 percent, but "we know that some patients still aren't receiving this important [risk] information", FDA Commissioner Scott Gottlieb said in a statement.

An agency spokeswoman said via email that the new requirements "ensure that the device continues to meet our standards for a reasonable assurance of safety and effectiveness". It comprises two metal coils that are inserted through the vagina and cervix into the fallopian tubes. "Every single woman receiving this device should fully understand the associated risks". The FDA is committed to continuing to use its full authorities to ensure the post-market safety of medical products. Although Essure sales have decreased by ~70%, the FDA believes that some women are still not being informed about the established risks of Essure prior to implantation. In addition, women have also reported experiencing headache, fatigue, weight changes, hair loss and mood changes, such as depression.

Bodies of Family Recovered After a Month
Court documents there show that one of the couple's daughters had come to school with bruises on her back and stomach. They could have also been swept away by seawater because no one in the SUV was wearing a seatbelt, officials said.

The patient brochure, "Patient-Doctor Discussion Checklist-Acceptance of Risk and Informed Decision Acknowledgement", must be reviewed with the prospective patient to ensure the patient understands the information about Essure implantation.

Even the action declared on Monday will call for health practitioners to be certain individuals sign up a form with a record acknowledging they've been informed of their implants' dangers, and also also necessitate the physician's signature.

The agency said Bayer, which manufactures the device, will be responsible for implementing the restrictions immediately and for ensuring that providers comply.

Essure is the only permanently implanted birth control device on the market that does not require surgery. Although the company is making "adequate progress", the FDA said today that it will require additional study sites to enroll more patients in the study.

However, numerous reports of adverse events, including procedural complications, need for second procedures, chronic pain, and device failure - i.e., patients became pregnant - prompted the agency to begin re-examining Essure in 2015. US health officials are placing new restrictions on a contraceptive implant that has been subject to thousands of reports of painful complications from women.


  • Malaysia's general election to take place on May 9: Election Commission

    Malaysia's general election to take place on May 9: Election Commission

    It acknowledged Tuesday that 14.968 million voters will cast their ballot, an increase of 1.7 million new voters from 2013. Prime Minister Najib Razak has been dogged by a corruption scandal involving an investment fund.
    Flu death toll in DE  increases to 34

    Flu death toll in DE increases to 34

    This number has nearly doubled from 69 cases for this time previous year , 64 cases to mid-May 2015 and 56 to mid-May in 2014. That was in 2015, and it was unusual - the three years before and two years after only saw one to two flu deaths each.
    Champions League: Salah sparks Liverpool comeback vs

    Champions League: Salah sparks Liverpool comeback vs

    Ahead of their Champions League quarter-final first leg against Liverpool , Manchester City were sitting pretty. Guardiola said City were on the wrong end of some poor refereeing decisions against Liverpool .
  • IPL 2018: How teams are placed in the standings after Matchday 3

    IPL 2018: How teams are placed in the standings after Matchday 3

    Yusuf Pathan and Manish Pandey will are ideal in the middle order while their bowling line-up is one of the deadliest this season. With this match, all the teams have played their first match with SRH on top of the table based on net run rate.
    SC refuses to interfere with Bengal VP poll process

    SC refuses to interfere with Bengal VP poll process

    Ghosh alleged that the TMC has managed to make Birbhum opposition-less with the help of the musclemen and the police. Opposition parties in West Bengal have alleged that their candidates are being obstructed from filing nominations.
    Israel's Labor party suspends ties with UK's Labour chief

    Israel's Labor party suspends ties with UK's Labour chief

    Hundreds protested against Labour's alleged anti-Semitism outside the party's headquarters and Parliament Square. Avi Gabbay said Tuesday he sent a letter to Jeremy Corbyn announcing his decision.
  • Arsenal boss Arsene Wenger hails exceptional Danny Welbeck after striker bags brace

    Arsenal boss Arsene Wenger hails exceptional Danny Welbeck after striker bags brace

    But with just nine minutes left on the clock, Welbeck grabbed the victor , moments after a poor miss from close range. Welbeck had not scored in the Premier League since September and had an injury lay-off earlier in the season.
    Featured Stock to Focus: Nvidia Corporation (NASDAQ:NVDA)

    Featured Stock to Focus: Nvidia Corporation (NASDAQ:NVDA)

    According to 2017Q4 Securities and Exchange form the Philippe Laffont decreased its holdings in Nvidia Corp ( NVDA ) by 0.39%. The computer hardware maker reported $1.72 EPS for the quarter, topping analysts' consensus estimates of $1.16 by $0.56.
    Honor 10 leaked picture reveals twilight signature color and dual camera system

    Honor 10 leaked picture reveals twilight signature color and dual camera system

    The Honor 10 will be powered by Huawei's in-house Hi-Silicon Kirin 970 chip, which is on par with the latest chip from its rivals. The same SoC from Huawei comes integrated with Neural Processing Unit (NPU) that enables artificial intelligence (AI) processing.
  • Erdogan says Afrin will be handed over to residents

    Erdogan says Afrin will be handed over to residents

    French opposition to Turkey's military operation in northern Syria against Kurdish forces has angered Erdogan's government. The YPG, abandoned by their US allies, withdrew from Afrin east towards Manbij, where a USA ground presence remains.
    EU says Facebook confirmed data of 2.7M Europeans 'improperly shared'

    EU says Facebook confirmed data of 2.7M Europeans 'improperly shared'

    Facebook is working to strengthen its system ahead of this year's USA midterm elections and other elections around the world. EU spokesman Christian Wigand says EU Justice Commissioner Vera Jourova will have a telephone call next week with Sandberg.
    Bill Clinton hails 'genius' of N.Ireland peace deal 20 years on

    Bill Clinton hails 'genius' of N.Ireland peace deal 20 years on

    As of March 2017, women's political participation in the (currently defunct) Northern Ireland Assembly stands at 30 per cent. There can't be agreement on those issues unless we somehow agree on what objective Northern Ireland actually now serves.