Yesterday U.S. health officials placed new restrictions on a permanent contraceptive implant that is reported to have given thousands of women painful complications—but the metal implant, called Essure, will remain on the market.
The Food and Drug Administration said only women who have had the opportunity to read and sign a brochure about the risks of the device will be able to receive the implant, which is made by Bayer. The checklist of risks must also be signed by the woman's doctor.
The new requirement comes almost two years after the FDA added its strongest warning to Essure, citing problems reported with the nickel-titanium implant. The agency also ordered Bayer to conduct a study of the device's safety.
Patients have reported cases of pain, bleeding, allergic reactions, and cases where the implant punctured the uterus or shifted out of place.
"Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren't receiving this important information," said FDA Commissioner Scott Gottlieb, in a statement. "That is simply unacceptable."
An agency spokeswoman said via email that the new requirements "ensure that the device continues to meet our standards for a reasonable assurance of safety and effectiveness."
In a statement after the announcement, Bayer said it will continue to tell health care providers about "the importance of appropriately counseling each patient on the benefits and risks of Essure."
Public health advocates questioned the FDA's new requirement, suggesting patients may not read the lengthy brochure.
"How many people do you know who would carefully read a 22-page document before signing it?" said Diana Zuckerman, president of the National Center for Health Research, a consumer advocacy group. "In addition to being much too long and technical, the information provided will be confusing to many consumers."
Bayer received FDA approval to sell Essure in 2002, and promoted the product to women as the only non-surgical option for permanent birth control. Essure consists of two nickel-titanium coils inserted into the fallopian tubes, where they spur the growth of scar tissue that blocks sperm from fertilizing a woman's eggs.
Netflix's 'Harry & Meghan' Docuseries Is Threatening to Overshadow William and Kate's Boston Visit
The stakes are high for the new Prince and Princess of Wales' first trip overseas since the death of the Queen.
By Rachel Burchfield
The Subtle Message the Prince and Princess of Wales Are Sending with Their Clothes in Boston This Week
Once you see it, you can’t unsee it.
By Rachel Burchfield
The Prince and Princess of Wales Have Made It Clear They Love Boston
But does Boston feel the same way?
By Rachel Burchfield
35 Ways Women Still Aren't Equal to Men
If anyone tries to tell you otherwise, show them these statistics.
By Brooke Knappenberger
How New York's First Female Governor Plans to Fight for Women If Reelected
Kathy Hochul twice came to power because men resigned amid sexual harassment scandals. Here, how she's leading differently.
By Emily Tisch Sussman
Why the 2022 Midterm Elections Are So Critical
As we blaze through a highly charged midterm election season, Swing Left Executive Director Yasmin Radjy highlights rising stars who are fighting for women’s rights.
By Tanya Benedicto Klich
Tammy Duckworth: 'I’m Mad as Hell' About the Lack of Federal Action on Gun Safety
The Illinois Senator won't let the memory of the Highland Park shooting just fade away.
By Sen. Tammy Duckworth
Roe Is Gone. We Have to Keep Fighting.
Democracy always offers a path forward even when we feel thrust into the past.
By Beth Silvers and Sarah Stewart Holland, hosts of Pantsuit Politics Podcast
The Supreme Court's Mississippi Abortion Rights Case: What to Know
The case could threaten Roe v. Wade.
By Megan DiTrolio
Sex Trafficking Victims Are Being Punished. A New Law Could Change That.
Victims of sexual abuse are quietly criminalized. Sara's Law protects kids that fight back.
By Dr. Devin J. Buckley and Erin Regan
My Family and I Live in Navajo Nation. We Don't Have Access to Clean Running Water
"They say that the United States is one of the wealthiest countries in the world. Why are citizens still living with no access to clean water?"
By Amanda L. As Told To Rachel Epstein