ibusinesslines.com
ibusinesslines.com August 20, 2018


Bayer Will Soon Stop Selling Essure Birth Control Devices

24 July 2018, 01:16 | Melissa Porter

Bayer to Stop Selling Essure in U.S.

Bayer to phase out Essure birth control device in U.S

Based on that investigation, the FDA issued a black-box warning-the agency's most serious kind of warning-and ordered Bayer to conduct a post-market study to evaluate the safety of Essure.

In April, the FDA said some women were not being properly informed of the risks associated with Essure before getting implanted and it limited its sale to healthcare facilities providing full information about its risks and benefits. Using a scope device that enters the uterus through the vagina, a doctor implants one coil in each of the openings of a woman's fallopian tubes (see the diagram at the bottom of this post).

In May, the FDA said doctors must show women a checklist of the device's risks before implanting it.

In their press statement, Bayer notes that the "increased reliance on other birth control options, such as long-acting reversible contraceptives, and inaccurate and misleading publicity about the device" is what contributed to the decline in interest for Essure.

In a statement, Bayer attributed the decision to a "decline in us sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable".


Dr. Yesmean Wahdan, an obstetrician/gynecologist at Bayer US Medical Affairs, Women's Healthcare, said in a video statement Friday that the company "made a business decision to discontinue sales and distribution because of a decline in sales".

The device was developed by Conceptus Inc. and acquired by Bayer in 2013.

Since Bayer will not be able to meet its expected enrollment numbers for this study that relied on enrolling patients who were newly implanted with Essure, we'll be working with the company to best determine how to move forward to answer the critical questions we posed concerning certain patient complications that may be experienced by patients who have Essure. The company said it continues to "stand behind the product's safety and efficacy". A self-described "data advocate", she analyzed public data on Essure and presented her findings to hospitals, patients and attorneys to help argue against the product.

On Tuesday, Firmalino and other Essure activists held a daylong protest outside Bayer's US headquarters in Whippany, N.J. As part of it, they broadcast a clip from the forthcoming Netflix documentary about medical device failures called The Bleeding Edge.

The FDA has received 27,000 reports of injuries related to Essure implants in the past 16 years. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.



Other News

Trending Now

International Champions Cup Report: Manchester City v Borussia Dortmund 21 July 2018
However, he is third choice behind Ederson and Claudio Bravo , with little chance of him playing for the Premier League champions. I've got a year left and I'm not going on loan again because my situation has changed. "I love all the leagues".

Johnny Manziel has reportedly been traded
Not only that, his teammates welcomed him with open arms - despite what anyone said about his checkered past. The only thing to clear up is "when". "This is quite a short week", Sherman said.

Tesla Reportedly Asked Suppliers for Cash Back to Show Profit
The firm is less focused on one-time reductions for this quarter as it is on reaching a "more sustainable long-term cost basis". Tesla had about $3.2 billion in cash as of the first quarter ended March 31, after spending about $1 billion in the quarter.

Trump privately frustrated over lack of progress on North Korea negotiations
North Korea has carried out a total of six nuclear tests, the most recent of which took place in September past year . Secretary of State Mike Pompeo echoed Brook's statement, saying the challenge with North Korea is not over.

Urges strict UN sanctions until N.Korea acts on denuclearization
The worldwide response has been divided with China and Russian Federation calling for an easing of sanctions. Ambassador Haley reminded the United Nations of how far they have come with the North since then.

Iran's Rouhani warns Trump 'war with Iran mother of all wars'
Tension between the USA and Iran has been high ever since Trump pulled out of the United States' 2015 nuclear deal with Iran. Iran has rejected talks with the US , and Rouhani has accused the USA of stoking an "economic war".

Intel leader Coats says he intended no disrespect to Trump
Moscow has likewise dismissed allegations about attempts to influence the U.S. elections as groundless on numerous occasions. Trump says in a Monday tweet: "remember, I gave up NOTHING, we merely talked about future benefits for both countries".