Bayer halts sales of Essure outside US
Bayer (ETR:BAYN) said today it is halting sales of its Essure contraceptive device outside the US in response to “commercial reasons” and not due to safety or product quality issues.
The company said it originally announced it would pull the device from the shelves in most countries in May, and added that it will not resume commercialization in the European Union with no plans to renew its CE Mark.
Bayer said it has seen a decline in demand, with a specific drop in France, after the CE Mark for Essure was temporarily suspended in August, according to a French press release.
The company went on to again reinfor...
Source: Mass Device - September 19, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Women's Health Bayer Source Type: news
Outpatient Hysteroscopy Adequate for Evaluating Postmenopausal Bleeding Outpatient Hysteroscopy Adequate for Evaluating Postmenopausal Bleeding
Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - August 23, 2017 Category: Consumer Health News Tags: Ob/Gyn & Women ' s Health News Source Type: news
Missouri judge slashes 86 plaintiffs from Essure suit against Bayer
A federal judge in Missouri cut 86 of the 94 plaintiffs from a group of consolidated lawsuits filed against Bayer (ETR:BAYN) over its Essure female sterilization device.
Essure is a small metal coil that’s placed in the fallopian tubes via catheter. The FDA said in 2015 that it received 5,093 complaints in the 13 years since Essure’s approval, including for pain or menstrual irregularities after using the device and complaints of the device breaking. In addition to five fetal deaths, there were four reports of adult deaths for reasons such as infection and uterine perforation, the FDA said.
In November 2016, the ...
Source: Mass Device - July 17, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Legal News Product Liability Women's Health Bayer Source Type: news
Predisposed And Unaware: How Race Called The Shots On My Health
I’m a black woman with uterine fibroids. These noncancerous growths, also called intramural fibroids, line the muscular wall of my uterus. Technically benign, they threaten to grow into larger, painful masses that could ultimately rob me of the ability to bear children.
Fibroids are common in all women, but research suggests that African American women are significantly more likely to develop uterine fibroids. In fact, in addition to a family history of fibroids, being African American is at the top of the list of causes for the condition. And black women aren’t only at a higher risk for developing fibroids. Th...
Source: Healthy Living - The Huffington Post - May 15, 2017 Category: Consumer Health News Source Type: news
My hysterectomy and cancer journey – Anya ’ s story
I had been suffering from heavy bleeding on and off since the birth of my second child in 2012 , medication and the contraceptive pill did nothing to ease the bleeding and I was referred to a gynaecologist, I initially saw a locum gynaecologist who persuaded me to have a Mirena coil fitted.
However that made matters matters worse and some six months later following several appointments with another gynaecologist, a hysteroscopy and scans it was discovered that coil had managed to lodge itself in my uterus and that the small fibroid I had had for years had suddenly enlarged in size. My gynaecologist recommended I had a hyst...
Source: The Hysterectomy Association - March 24, 2017 Category: OBGYN Authors: Linda Parkinson-Hardman Tags: Health cancer hysterectomy stories Source Type: news
My hysterectomy and cancer journey – Anya ’ s story
I had been suffering from heavy bleeding on and off since the birth of my second child in 2012 , medication and the contraceptive pill did nothing to ease the bleeding and I was referred to a gynaecologist, I initially saw a locum gynaecologist who persuaded me to have a Mirena coil fitted.
However that made matters matters worse and some six months later following several appointments with another gynaecologist, a hysteroscopy and scans it was discovered that coil had managed to lodge itself in my uterus and that the small fibroid I had had for years had suddenly enlarged in size. My gynaecologist recommended I had a hyst...
Source: The Hysterectomy Association - March 24, 2017 Category: OBGYN Authors: Linda Parkinson-Hardman Tags: Health cancer hysterectomy stories Source Type: news
My hysterectomy and cancer journey – Anya ’ s story
The post My hysterectomy and cancer journey – Anya’s story appeared first on Hysterectomy Association.
I had been suffering from heavy bleeding on and off since the birth of my second child in 2012 , medication and the contraceptive pill did nothing to ease the bleeding and I was referred to a gynaecologist, I initially saw a locum gynaecologist who persuaded me to have a Mirena coil fitted.
However that made matters matters worse and some six months later following several appointments with another gynaecologist, a hysteroscopy and scans it was discovered that coil had managed to lodge itself in my uterus and ...
Source: The Hysterectomy Association - March 24, 2017 Category: OBGYN Authors: Linda Tags: Your Stories cancer leiomyosarcoma Source Type: news
My hysterectomy and cancer journey – Anya ’ s story
I had been suffering from heavy bleeding on and off since the birth of my second child in 2012 , medication and the contraceptive pill did nothing to ease the bleeding and I was referred to a gynaecologist, I initially saw a locum gynaecologist who persuaded me to have a Mirena coil fitted.
However that made matters matters worse and some six months later following several appointments with another gynaecologist, a hysteroscopy and scans it was discovered that coil had managed to lodge itself in my uterus and that the small fibroid I had had for years had suddenly enlarged in size. My gynaecologist recommended I had a hyst...
Source: The Hysterectomy Association - March 24, 2017 Category: OBGYN Authors: Linda Parkinson-Hardman Tags: Health cancer hysterectomy stories Source Type: news
Femasys Inc. raises $4m
Femasys Inc. said last week that it raised $4 million, according to a regulatory document filed with the SEC. Atlanta-based Femasys wrote that 8 investors contributed to the round and that it paid Los Angeles-based investment bank Salem Partners LLC an estimated $200,000 in sales commissions.
The 1st sale in the financing round happened on Jan. 6 this year, the company said in its filing.
In December last year, Femasys closed a $40 million Series C round that it said it will use to fund a pivotal trial for its FemBloc permanent female contraception device.
The financing round was arranged and led by Salem Partners, with ...
Source: Mass Device - January 17, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Funding Roundup Gynecological Wall Street Beat Women's Health Femasys Inc. Source Type: news
Femasys raises $40m Series C for FemBloc permanent female contraception device
Femasys said earlier this month that it closed on a Series C round worth $40 million it plans to use on a pivotal trial of its FemBloc permanent female contraception device now that it has FDA approval for the study.
Atlanta-based Femasys said the round was arranged and led by Los Angeles-based investment bank Salem Partners, with “multiple institutional investors, family offices and a multibillion-dollar global medical device company” also contributing.
The company bills FemBloc as a non-surgical procedure that can be performed at the doctor’s office that’s designed to occlude the fallopian tubes...
Source: Mass Device - December 29, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Funding Roundup Wall Street Beat Women's Health Femasys Inc. Source Type: news
French women file complaints over complications with Bayer ’ s Essure
Two French women who’ve used Bayer‘s (ETR:BAYN) controversial Essure contraceptive implant have filed a legal complaint alleging similar side-effects to those filed in the U.S.
Essure is a small metal coil that’s placed in the fallopian tubes via catheter. The FDA said last year that in the 13 years since Essure’s approval, the agency had received 5,093 complaints, including for pain or menstrual irregularities after using the device, and complaints of the device breaking. In addition to 5 fetal deaths, there were 4 reports of adult deaths for reasons such as infection and uterine perforation, the FDA said...
Source: Mass Device - December 9, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Legal News Women's Health Bayer HealthCare Source Type: news
Better late than never as they say! – Karron ’ s story
I write this story some 6 months after my hysterectomy, I was one of those people that used to pop in and read all the stories, which I must confess really helped me, especially the hints and the special things that would help. So here is my story. Sorry it is late.
I presented at A&E this time last year with gallstone pancreatitis seriously ill, at the time the medics found I had a mass in my womb, which I did not know about, I just thought I had a bulky tummy. Turns out my womb was full of fibroids, totally obstructing the whole of the womb. This made sense retrospectively as I was starting to have problems with my b...
Source: The Hysterectomy Association - December 8, 2016 Category: OBGYN Authors: Linda Parkinson-Hardman Tags: Health fibroids hysterectomy stories Source Type: news
Better late than never as they say! – Karron ’ s story
The post Better late than never as they say! – Karron’s story appeared first on Hysterectomy Association.
I write this story some 6 months after my hysterectomy, I was one of those people that used to pop in and read all the stories, which I must confess really helped me, especially the hints and the special things that would help. So here is my story. Sorry it is late.
I presented at A&E this time last year with gallstone pancreatitis seriously ill, at the time the medics found I had a mass in my womb, which I did not know about, I just thought I had a bulky tummy. Turns out my womb was full of fibroids, t...
Source: The Hysterectomy Association - December 8, 2016 Category: OBGYN Authors: Linda Tags: Your Stories fibroids Source Type: news
Better late than never as they say! – Karron ’ s story
I write this story some 6 months after my hysterectomy, I was one of those people that used to pop in and read all the stories, which I must confess really helped me, especially the hints and the special things that would help. So here is my story. Sorry it is late.
I presented at A&E this time last year with gallstone pancreatitis seriously ill, at the time the medics found I had a mass in my womb, which I did not know about, I just thought I had a bulky tummy. Turns out my womb was full of fibroids, totally obstructing the whole of the womb. This made sense retrospectively as I was starting to have problems with my b...
Source: The Hysterectomy Association - December 8, 2016 Category: OBGYN Authors: Linda Parkinson-Hardman Tags: Health fibroids hysterectomy stories Source Type: news
Better late than never as they say! – Karron ’ s story
I write this story some 6 months after my hysterectomy, I was one of those people that used to pop in and read all the stories, which I must confess really helped me, especially the hints and the special things that would help. So here is my story. Sorry it is late.
I presented at A&E this time last year with gallstone pancreatitis seriously ill, at the time the medics found I had a mass in my womb, which I did not know about, I just thought I had a bulky tummy. Turns out my womb was full of fibroids, totally obstructing the whole of the womb. This made sense retrospectively as I was starting to have problems with my b...
Source: The Hysterectomy Association - December 8, 2016 Category: OBGYN Authors: Linda Parkinson-Hardman Tags: Health fibroids hysterectomy stories Source Type: news
