Navigation Links
OB/GYN experts call for more testing of permanent birth control device; Arentz Law Group reports
Date:9/28/2015

PHOENIX, Sept. 28, 2015 /PRNewswire/ -- A panel of experts from the U.S. Food and Drug Administration (FDA) heard arguments Thursday regarding the regulation of the permanent birth control device Essure, which has been linked to at least two deaths and has been the subject of thousands of recorded complaints.

According to the New York Times' Sabrina Tavernise who covered the public meeting held by the FDA's Obstetrics and Gynecology Devices Panel, experts drilled representatives from Bayer Healthcare Pharmaceuticals about their small, coiled sterilization device, which has held an FDA approval since 2002. Several Essure patients, calling for the recall of the device, also gave their testimony at the public meeting.

Tavernise reported that several experts on the panel recommended that more testing be done as the device has been poorly tracked since being available, and clinical testing results released by Bayer failed to include some women who had experience problems. The FDA doesn't necessarily have to act on the panel's advice, but it is said that it often does.

According to the article, several women in attendance rejected the panel's recommendation, calling for the outright recall of the device on behalf of the more than 21,000 women in a growing Facebook network of Essure patients.

The hearing was called after growing concerns over the safety of the device. According to Aboutlawsuits.com, a woman testified before the National Center for Health Research on Capitol Hill last summer over alleged injuries incurred by the Essure Implant. In February 2015 a petition was filed with the FDA to remove the device from the market, following a uterine puncture death by Bayer to the FDA.

Later in 2015, the FDA opened an investigation of the Essure in response to allegations that the company falsified and altered medical records during clinical trials, failed to report adverse events, made fraudulent claims about the device's safety and efficacy and used defective materials in manufacturing.

"Women chose to have this procedure without being informed of the debilitating and in many cases, life altering side effects," says Robert Arentz, founding partner of the Arentz Law Group.

The FDA reports that, since 2002, the agency has received 5,093 medical device reports regarding Essure, including at least six death reports. The agency states that two of the four adult deaths in the reports was "...reportedly due to uterine perforation during device placement, one death related to an air embolism during device removal surgery..."

The Arentz Law Group is offering free legal consultations to all women who have suffered negative health effects due to Essure Permanent Birth Control Implant. Essure Implant victims are encouraged to visit http://arentzlaw.com/essure-injury-lawyers/ or call 1-800-305-6000 for more information about their legal options.

Contact:
Arentz Law Group
1-800-305-6000
info@arentzlaw.com

Photo(s):
http://www.prlog.org/12496635

Press release distributed by PRLog


'/>"/>
SOURCE Arentz Law Group
Copyright©2015 PR Newswire.
All rights reserved

Related medicine technology :

1. Philips Showcases Ultrasound Innovations that Address Clinical Challenges in the OB/GYN Segment at ISUOG World Congress
2. SOAPware President Randall Oates, M.D. Among First NCQA Certified Patient-Centered Medical Home Content Experts
3. International Mesothelioma Experts Present Promising New Research Findings at the 3rd Annual International Symposium on Lung-Sparing Therapies for Malignant Pleural Mesothelioma
4. NovoBioPharma, Partnership of Top Life Science Experts, Launches
5. Leading Experts in Parenting, Education and Medicine Partner to Launch Head Lice Awareness Initiative
6. CPhI et CPhI Pharma Evolution ajoutent des noms réputés à leur panel dexperts du secteur
7. Over 55 Industry Experts Expected to Attend CPhI Worldwides Pre-Connect Conference - the Pharma Industrys Leading Global Event
8. ProfNet Experts Available on Vaccines, Preconception Health, More
9. Key Industry Experts Share Their Insights on How Inhalation Drug Delivery Systems Are Gathering Momentum
10. BSI Offers Medical Device Manufacturers Exclusive Access to Global Panel of Experts in 3 Key Cities
11. Cancer Experts Detail New Approaches to Liver Cancer Treatment with Stereotactic Ablative Radiotherapy
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/7/2020)... (PRWEB) , ... January 06, 2020 , ... ... adults living with memory impairment, has announced the Best Memory Care Facilities in ... access to experts, facility features and amenities. , According to the ...
(Date:1/3/2020)... HILLS, Calif. (PRWEB) , ... January 02, 2020 , ... ... Dr. Matt Nejad , leading expert and educator in cosmetic and biomimetic dentistry, ... Institute with a new website at http://www.nejadinstitute.com . , Dentists from around ...
(Date:1/3/2020)... , ... January 03, 2020 , ... ... medicinal attributes to transform the health of their patients. Although many medical professionals ... prescription is not needed. Smart shoppers are finding this product online. , In ...
Breaking Medicine Technology:
(Date:1/10/2020)... (PRWEB) , ... January 10, 2020 , ... ... the complexities of autoimmune conditions, HMP, a leading healthcare event and education company, ... help improve patient care. , The Autoimmune Learning Network serves as a robust ...
(Date:1/10/2020)... (PRWEB) , ... January 10, 2020 , ... ... today announced that its Certified Pediatric Emergency Nurse (CPEN) specialty nursing ... (ABSNC). , The CPEN is a national board certification earned by registered ...
(Date:1/8/2020)... Va. (PRWEB) , ... January 09, 2020 , ... ... 30 Pharma Companies, An FDAnews/CenterWatch Webinar, Thursday, Jan. 23, 2020 • 1:30-3:00 p.m. ... (RWE) and real world data (RWD) to generate evidence and identify gaps and ...
(Date:1/7/2020)... ... January 07, 2020 , ... Midmark Corp., a ... six trends that will significantly impact the point of care ecosystem, where the ... between a provider and patient is the most important aspect of the healthcare ...
(Date:1/7/2020)... ... ... Twenty-six people, all but one who live with Young Onset Parkinson’s Disease (YOPD) ... 6th World Parkinson Congress. The participants, representing 11 countries , will each host ... in 2020. The group aims to raise at least $50,000 for travel grants to ...
Breaking Medicine News(10 mins):