Essure Discontinuation Doesn & #039;t Mean the End to FDA Scrutiny
FDA wants the public to know it is taking steps to make sure the long-term safety profile of a controversial birth control device continues to be studied even after U.S. sales of the device are discontinued at the end of the year. While this seems like a good idea, in theory, patient advocates have concerns about the validity and feasibility of the required post-market study.
Bayer announced in July that it would stop selling the Essure device at the end of the year due to a decline in U.S. sales. FDA Commissioner Scott Gottlieb said at the time that the agency would still hold the compa...
Source: MDDI - December 20, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news
Health Highlights: Dec. 19, 2018
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Tubal Ligation Most Common Birth Control Method Used by U.S. Women
Female sterilization (tubal ligation) is the most common method of birth... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - December 19, 2018 Category: General Medicine Source Type: news
Tubal Ligation Most Common Birth Control Method Used by U.S. Women
Title: Tubal Ligation Most Common Birth Control Method Used by U.S. WomenCategory: Health NewsCreated: 12/19/2018 12:00:00 AMLast Editorial Review: 12/19/2018 12:00:00 AM (Source: MedicineNet Womens Health General)
Source: MedicineNet Womens Health General - December 19, 2018 Category: OBGYN Source Type: news
Medical News Today: Can you get pregnant after tubal ligation?
Tubal ligation, or getting your tubes tied, is considered a permanent method of birth control. However, it is possible to become pregnant after undergoing the procedure. Here, learn how a woman can get pregnant following tubal ligation surgery, what the risks are, and when to see a doctor. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - September 12, 2018 Category: Consumer Health News Tags: Pregnancy / Obstetrics Source Type: news
Netflix ’ s ‘ The Bleeding Edge ’ raises big questions for medical device manufacturers
Sandra Maddock, president and CEO, IMARC Research
Thanks in large part to innovation in the medical device industry, the average human lifespan has nearly doubled in the past hundred years. Medical devices have undoubtedly improved the quality of life for millions of people, too.
But a provocative new Netflix documentary raises an important question: Is there a point when innovation goes too far?
The Bleeding Edge, produced by Academy-Award nominated filmmakers Kirby Dick and Amy Ziering, tells the stories of patients who say they’ve suffered serious health problems as a result of recent medical devices being used in t...
Source: Mass Device - August 24, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog IMARC Source Type: news
Desire for Sterilization Reversal Among U.S. Females: Increasing Inequalities by Educational Level
CONCLUSIONFuture research should consider how insurance coverage of all methods under the Affordable Care Act may affect use of sterilization and desire for reversal. (Source: The Guttmacher Institute)
Source: The Guttmacher Institute - August 15, 2018 Category: International Medicine & Public Health Authors: Guttmacher Source Type: news
Permanent Birth Control: His and Her Options
If you're sure you don't want kids, find out from WebMD what's involved with permanent birth control options like vasectomy and tubal ligation. (Source: WebMD Health)
Source: WebMD Health - April 21, 2018 Category: Consumer Health News Source Type: news
Hysteroscopic Versus Laparoscopic Sterilization — Is One Safer?
For women seeking tubal sterilization, both hysteroscopic and laparoscopic procedures carry benefits and risks, according to a JAMA study. Using French health databases, researchers studied... (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - January 23, 2018 Category: Primary Care Source Type: news
Tubal ligation reversal
(Source: MayoClinic.com Full Feed)
Source: MayoClinic.com Full Feed - January 12, 2018 Category: Consumer Health News Source Type: news
Tubal Sterilization
Tubal Ligation (Tubal Sterilization) (Source: eMedicineHealth.com)
Source: eMedicineHealth.com - December 19, 2017 Category: General Medicine Source Type: news
Contraceptive Choice and Use of Dual Protection Among Women Living with HIV in Canada: Priorities for Integrated Care
CONCLUSIONSFuture research should explore how sustained ART and broader contraceptive options can support women's sexual and reproductive health care needs. (Source: The Guttmacher Institute)
Source: The Guttmacher Institute - December 1, 2017 Category: International Medicine & Public Health Authors: Guttmacher Source Type: news
What Are Women Told When Requesting Family Planning Services at Clinics Associated with Catholic Hospitals? A Mystery Caller Study
CONCLUSIONSAdherence to church directives is inconsistent at Catholic-associated clinics. Women visiting such clinics who want highly effective methods may need to rely on less effective methods or delay method uptake while seeking services elsewhere. (Source: The Guttmacher Institute)
Source: The Guttmacher Institute - October 18, 2017 Category: International Medicine & Public Health Authors: Guttmacher Source Type: news
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
Fortimedix launches short instruments for SymphonX single-port platform
Fortimedix Surgical said today it launched a shorter set of instruments for its SymphonX single-port surgical platform in the US.
The newly launched product line offers shorter instrumentation for use with the SymphonX surgical platform, a single-port system designed for microlaparoscopic surgical procedures, Fortimedix said.
The instrument portfolio for the SymphonX system includes products for grasping, mobilizing, dissecting, retracting, cutting, cauterizing, ligating and suction and irrigation of tissues and vessels, the Netherlands-based company said.
“This product line extension was developed in response to sur...
Source: Mass Device - August 7, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Surgical Fortimedix Source Type: news
Coerced sterilizations of Indigenous women in Saskatoon troubling: Bennett
Indigenous Affairs Minister Carolyn Bennett says she's troubled by reports of Indigenous women in and around Saskatoon being coerced into tubal ligation procedures. (Source: CBC | Health)
Source: CBC | Health - August 4, 2017 Category: Consumer Health News Tags: News/Canada/Saskatchewan Source Type: news
