MND, July, 23, 2015 ~ The following is from the FDA’s website. The issue of the controversial Essure birth control implant has made the headlines.
Women claim they have been injured by the implant which is made by Bayer HealthCare. The implant is placed through the vagina and into the fallopian tube to prevent pregnancy. Bayer calls this “permanent birth control that works with your body to create a natural barrier against pregnancy.” Bay says the reports of chronic pelvic pain in women are rare and that also rare are instances where the device may migrate through the fallopian tubes and require surgery.
Essure is made of a nickel-titanium alloy which can elicit an allergic reaction. Women have experienced perforation, migration, chronic pain, allergic reactions, bloating, migraines, hysterectomies and headaches, among other symptoms. Additionally the birth control device often does not work. Here is a report by an allegedly injured woman to the FDA. Here is the Facebook page for Essure Problems.
A warning to screen a woman for nickel allergies before implant was removed by the FDA reportedly at the behest of Bayer Healthcare in 2011.
Essure received Premarket approval (PMA) by the FDA in November 2002 making Bayer immune from litigation under federal preemption which shields a manufacturer from litigation if the device receives FDA approval.
Panels are frequently made up of professionals who have some conflicting relationships with industry. They are required to disclose those relationships which are often financial. Here is the FDA’s page on Advisory Committees. http://www.fda.gov/AdvisoryCommittees/default.htm.
The FDA has a page on Essure here.
Here is the Agenda in Silver Spring, Maryland at the FDA White Oak campus, 10903 New Hampshire Ave. Bldg. 31 Conference Center, the Great Room (rm 1503). 8am-6pm. Here is the link.
The link for the Webcast is here.
Those interested in speaking before the panel should have their request made on or before August 24, 2015.
Here is a Roster of the Ob/Gyn Devices Panel.
Parallels to Pelvic Mesh
The parallels to pelvic mesh are very compelling. Both are devices intended to be permanently implanted in women. Many women who have an Essure device implanted end up with it removed via a hysterectomy. Often pelvic mesh is inserted prophylactically during a hysterectomy to prevent pelvic organs from descending.
Often women with Essure problems are turned away from the doctors. Doctors tell them the backlash to Essure is a joke. Medical records have been altered reporting that women are very satisfied with the procedure when they are not. Many mesh patients report to MND the same alteration to their medical records.
According to a story in the Dallas Observer, the Cleveland Clinic participated with industry, as it did in Florida in encouraging pelvic mesh. Medical sales representatives often direct doctors on how to implant the Essure and are sometimes found in the surgery room. In some cases women have received more than one implant in each tube at the urging of the sales rep who is not a doctor.
Women with complications have gathered online in a virtual community to discuss their symptoms and solutions from both an Essure and pelvic mesh implant. They share information about trustworthy doctors and insurance companies that are becoming aware of the problem.#
Melayna Lokosky – Clean up your mesh
FDA Premarket Approval; letter for Essure, November 2002
Dallas Observer, Amy Silverstein, Trial and Error on the Essure Birth Control device, July 22, 2015