Bill Text: NJ SR42 | 2016-2017 | Regular Session | Introduced
Bill Title: Urges FDA to withdraw approval of Essure permanent birth control device.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Introduced - Dead) 2016-03-10 - Introduced in the Senate, Referred to Senate Health, Human Services and Senior Citizens Committee [SR42 Detail]
Download: New_Jersey-2016-SR42-Introduced.html
Sponsored by:
Senator LORETTA WEINBERG
District 37 (Bergen)
SYNOPSIS
Urges FDA to withdraw approval of Essure permanent birth control device.
CURRENT VERSION OF TEXT
As introduced.
A Senate Resolution urging the FDA to withdraw approval of the Essure permanent birth control device.
Whereas, Essure is a permanent birth control method for women which requires implantation rather than a surgical incision; and
Whereas, In the implantation procedure, a health care provider inserts flexible coils into the fallopian tubes, and over a period of about three months, tissue forms around the inserts. The build-up of tissue creates a barrier that keeps sperm from reaching the eggs, thus preventing conception; and
Whereas, Essure is considered a permanent form of birth control and therefore is not intended to be removed; and
Whereas, Over the past several years, the U.S. Food and Drug Administration (FDA) has been examining the growing number of reports of harm with Essure; and
Whereas, The adverse events reported associated with the use of Essure include persistent pain, perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, allergy or hypersensitivity reactions; and
Whereas, Some women have had to have surgical procedures to remove Essure due to these adverse events; and
Whereas, Essure failure, and, in some cases, incomplete patient follow-up have resulted in unintended pregnancies; and
Whereas, The FDA has received reports of fetal complications including miscarriages in women who became pregnant following Essure placement; and
Whereas, Due to many reports of problems with Essure, the FDA convened a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee on September 24, 2015, to hear expert scientific and clinical opinions as well as patients' experiences regarding the benefits and risks of Essure; and
Whereas, The FDA opened a public docket soliciting comments on Essure, which remained open from July 22, 2015 until October 24, 2015, and received more than 2,800 comments; and
Whereas, The information provided through the panel meeting and docket is under review by the FDA, which expects to complete the review and communicate publically about its assessment of Essure safety at the end of February 2016; and
Whereas, Given the number of adverse events related to Essure reported to the FDA, it is incumbent upon them to protect the health of women who are implanted with, or who may be considering implantation with, the Essure device; now, therefore,
Be It
Resolved by the Senate of the State of New
Jersey:
1. This house urges the Commissioner of Food and Drugs to issue an order under section 515(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(e)) withdrawing approval for Essure.
2. Copies of this resolution, as filed with the Secretary of State, shall be transmitted by the Secretary of the Senate to the Commissioner of Food and Drugs, and every member of Congress elected from this State.
STATEMENT
This resolution urges the Commissioner of Food and Drugs to issue an order under section 515(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(e)) withdrawing approval for Essure.
Essure is a permanent birth control method for women that requires implantation rather than a surgical incision. In the implantation procedure, a health care provider inserts flexible coils into the fallopian tubes, and over a period of about three months, tissue forms around the inserts. The build-up of tissue creates a barrier that keeps sperm from reaching the eggs, thus preventing conception.
Over the past several years, the U.S. Food and Drug Administration (FDA) has been examining the growing number of reports of harm with Essure, including persistent pain, perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, allergy or hypersensitivity reactions. Some women have had to have surgical procedures to remove Essure due to these adverse events. Essure failure, and, in some cases, incomplete patient follow-up have resulted in unintended pregnancies, and the FDA has received reports of fetal complications including miscarriages in women who became pregnant following Essure placement.
Due to many reports of problems with Essure, the FDA convened a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee on September 24, 2015, to hear expert scientific and clinical opinions as well as patients' experiences regarding the benefits and risks of the Essure System. The FDA also opened a public docket soliciting comments on Essure, which remained open from July 22, 2015 until October 24, 2015, and received more than 2,800 comments. The information provided through the panel meeting and docket is under review by the FDA, which expects to complete the review and communicate publically about its assessment of Essure safety at the end of February 2016.
