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Saint of the DayBook ReviewsGuest Columnist

 

 Call to Continuing Conversion and Rite of Election 2019

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March 10, 2019

Mathematical solution to the Sock puzzle

Feb. 24, 2019

Local youth attend World Youth Day in Panama

Annual QUEST weekend honors Scouts

   The Dead Sea Scrolls series

 

   St. Nicholas School, Kinsley, Advent Cantata, Dec. 7, 2008

 

   

 

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Women stunned at FDA's failure

to remove Essure from market 

Washington D.C., Mar 3, 2016 / 03:02 am (CNA/EWTN News) - The FDA announced Monday that it will add its strictest warning to the label of Essure, a sterilization device in the form of flexible metal coils inserted into the fallopian tubes.

But the decision still comes as a blow to  thousands of “E-sisters” – women who have experienced the often debilitating side effects of the device and who have been pushing to get Essure completely removed from the market.

“We are outraged that it appears as if the FDA is going to leave Essure on the market while it implements a draft guidance and labeling recommendations within a black boxed warning as well as ordering new clinical studies,” the group said in a statement on their website.

“Clearly Essure's PMA (pre-market approval) should be revoked and the device should be pulled from the market. These studies could take several years, and leaving the device on the market will only put more women's lives at risk.”

A so-called “black box” warning has been recommended for the device, which is “designed to call attention to serious or life-threatening risks” of the device including “persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding and allergy or hypersensitivity reactions,” according to an FDA statement.

Touted as the only form on non-surgical permanent birth control, implanted Essure coils are supposed to stay in the fallopian tubes, where they create a chronic infection causing scar tissue to form, effectively closing the tubes and rendering the woman sterile. The device was first manufactured by the group Conceptus and pre-approved by the FDA before hitting the markets in 2002. In June 2014, Conceptus was bought by Bayer, which has continued to manufacture and distribute Essure.

In addition to the “black box” warning, the FDA asked Bayer to include a “patient decision checklist” in Essure's packaging, “to ensure women receive and understand information regarding the benefits and risks of this type of device,” and is accepting the public’s input on the device for 60 days.  

The FDA has also ordered Bayer to conduct a three-year clinical study in which they will follow 2,000 women who have been implanted with Essure, and compare them to women who’ve had different sterilization procedures. The FDA expects Bayer to submit a study protocol within 30 days and the company is required by law to begin the study within 15 months, CNN reports. If Bayer does not comply, the FDA can declare the device misbranded.

The Facebook page “Essure Problems” is over 27,000 members strong (up from 14,000 just last year) and serves as a place where the “E-sisters” women band together for support and protest the device. They tell their stories to women considering the device and provide the names and locations of doctors who won’t dismiss women’s Essure complaints.

“We have provided the FDA with enough relevant data to prove that Essure is unsafe,” the group said in a statement following the FDA’s latest announcement.

“Take the device off the market and revoke PMA. Do not continue to allow more women to be harmed. Unless the FDA takes those steps, we intend to push for Congress to force the hand of the FDA.  We will not be stopped or silenced.”

Rep. Mike Fitzpatrick, a Republican from Pennsylvania, introduced the “E-free” act to Congress in November, a bill calling for the device to be pulled from the market. He said the latest move from the FDA is unacceptable in the face of all the women who have already suffered because of Essure.

“It's unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and ask the manufacturer to perform another study while leaving Essure on the market,” he said in a statement following the announcement.

“It's been done. The evidence is all there: Tens of thousands of injured women and hundreds of fetal deaths.”

On the “Essure Problems” Facebook page, women log complaints about chronic pain, allergic reactions, perforated organs, migrating coils, and fetal disfigurement caused by the device.

Dr. William Maisel, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health, said in a news briefing Monday that the agency has received 631 reports of women becoming pregnant while using the product, and 294 reports of pregnancy losses.

“Like all forms of birth control, Essure is not perfect and women may become pregnant despite use of the device. The lack of an Essure confirmation test is the most common factor contributing to unintended pregnancies in women with Essure,” Maisel said.

The FDA has received about 10,000 complaints of adverse effects since the device’s approval in 2002. Instructions for how to file a complaint about Essure can be found on the Essure Problems website.

For 60 days, patients and doctors can submit their feedback to the FDA on the device, which will be taken into consideration before the addition of the new warning labels.

 

 

Past Issues

Feb. 10, 2019

Jan. 27, 2019

Jan. 13, 2019

Dec. 23, 2018

Dec. 9, 2018

Nov. 25, 2018

Nov. 11, 2018

Oct. 28, 2018

Oct. 14, 2018

Sept. 16, 2018

KEYWORDS, PHRASES: 2018 Golf Classic; student athletes; physically challenged; Leonard Stegman; Lesson in forgiveness; Sending us on a mission

Sept. 2, 2018

KEYWORDS, PHRASES: Priest crisis; Scandal; Opioid addictions; Seeds of Suicide; Leightons; St. Anne; Vincke; seminarians; Dominican Sisters; Stewardship Conference; Dead Sea Scrolls; PSR programs; Roe V. Wade

 

August 12, 2018

KEYWORDS, PHRASES: Prayer and Action; Totus Tuus; Janee Bernal; Diana Ramirez; Heidy Ramirez; Bishop Gilmore honored for 20 years ministry; suicide; contraception and abortion; Dead Sea Scrolls; Humanae Vitae; certification in youth ministry; Chuck Weber; Cathedral rectory chapel; Sister Viola Heichelbech; Adam Urban

July 15, 2018

KEYWORDS, PHRASES: Immigration Protest/Rally; Faith and Light Fiesta; Seeing the Dead Sea Scrolls; Corpus Christi procession; Prayers for priests; Sisters turn 100; Michael Brungardt; Gerald Vincke; Massacre in San Salvador; Action for Alex 

 

June 3, 2018

KEYWORDS, PHRASES: Parish Pray for Priestly Vocations; Appeal reaches $10 million; Gangs; Seminarians; Pam Willis; Why I like being a priest; Happy Father's Day; Patricia Lujan; Tyler and Rachel Bennett; Adoption Protection Act.

May 20, 2018
KEYWORDS, PHRASES: Track meet; Beloved Sinners; Benjamin Martin retires; Smiles; Future of Fortune Telling; Hoisington mission; DofI; Getting Equipped; Spring Social; First Communion; Confirmation
KEYWORDS, PHRASES: Track meet; Beloved Sinners; Benjamin Martin retires; Smiles; Future of Fortune Telling; Hoisington mission; DofI; Getting Equipped; Spring Social; First Communion; Confirmation

May 6, 2018

KEYWORDS, PHRASES: Archbishop Romero; Seeing, Touching, Tasting; Exhortation; Father Patrick Conroy; Happy Mother's Day; A child on your doorstep; Vibrant Ministries Grant; From the heart of a young father; Love Gives Life; Roman Holiday; Smartphone; retirement
Fossil Hunting

 

April 15, 2018

 KEYWORDS, PHRASES: Easter Vigil; Angelica Village; Colorado woman; The art of anger; Cimarron Couple; Staats; Adoption; 

Father Ultan Murphy anniversary; Coughlan; Spiritual Advisor to Hoodlums; Woman of Courage; Oration contest; Darcy Feist  

 

April 1, 2018

 

 KEYWORDS, PHRASES: Defending Adoption; Led by the Spirit; Knights; ABC Pregnancy Center;
Memorial of Mary; Homeless; Relics; Down syndrome abortion; Chrism Mass

 

March 18, 2018

KEYWORDS, PHRASES: SKYAC; Aleksandr Men; Fasting for Priestly Vocations; Uganda; School for deaf; Rannah Evetts; Oberle; Rachel and Doug Trombley; Oscar Romero; Paul VI; DACA

 

 

March 4, 2018

KEYWORDS, PHRASES: Fasting for priestly vocations; Father Juan; Fasting and prayer;
Quest Weekend 2018; DACA; With God, anything is possible; Homelessness in our communities; Rhubarb, Kansas;
What's the point of fasting; Rite of Election; same-sex couples

 

Feb. 18, 2018

KEYWORDS, PHRASES: Catholic Schools Week; Rachel Doll; Ellinwood; Great Bend; Garden City; Ness City; Dodge City; Sister Rita Schwarzenberger; Nigeria; Bishop Hermes; Fasting for Priestly Vocations; World Day for Consecrated Life; 50th Anniversary St. Dominic School; What will life be like in 50 years?

 

 

Feb. 4, 2018

 

KEYWORDS, PHRASES: March for Life; Tracy and Ross Smith; Adoption; Vibrant Ministries; Faith and Light;
Pro-Life; Mortal sin to discard elderly; DACA; Abortion; Dreamers; Human Trafficking

 

Jan. 21, 2018

 KEYWORDS, PHRASES: Louise Korbe; Anne Frank; Miep Gies; Home Heat; Father Solanus

 

Jan. 7, 2018

KEYWORDS, PHRASES: Good news and kingdom living; dreamers; Sister Teresa Orozco; Infant Adoption; Elderly; a moral conundrum; seminarian; feast of Our Lady of Guadalupe

 

 

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