NEW YORK – Severe headaches, heavy bleeding and countless other complications could be the result of what was once marketed as a ‘safe’ implant. Thousands of women are now questioning the safety of the popular birth control device “Essure” after many of them have reported severe side effects. ABC News reports some of these women were in Washington, demanding the U.S. Food and Drug Administration (FDA) to pull the product off the market.
“These side effects are real and our experiences are real,” Amanda Holt told the team of FDA panelists.
Patients like Holt have reported a long list of potential side effects ranging in scope and severity. Many women claim the device failed and resulted in pregnancy and in some cases the device may be linked to stillbirths. The device, which is inserted into the fallopian tubes, was placed on the market in 2002 but the device manufacturer didn’t change its warnings until 2014.
Defective product attorneys at Cellino & Barnes are now evaluating Essure cases – and those injured could be entitled to significant compensation.
“This device has been documented to cause severe injuries included but not limited to device migration, perforations and debilitating side effects,” dangerous drug attorney Mike Williams said. “Some women had pain so severe they required doctors to surgically remove the device, which was supposed to be a permanently emplaced contraceptive implant.”
Other birth control devices such as the Merina IUD require removal after five years. Other implants like hip devices can be under warranty for a decade and patients should expect future surgeries. However, Essure is marketed as a permanent implant and it’s not specifically designed to be the surgically removed.
Doctors report some women have even died as a result of complications from the surgery or the device itself.
The FDA panel will recommend more research about allergic reactions and side effects caused by Essure, according to ABC News. The panel will also suggest adjustments to the label and more training for doctors who are implanting or removing the implant.
On its website, the FDA acknowledges receiving a large number of reports and complaints related to Essure, including at least 11 deaths:
From Nov. 4, 2002, Essure’s approval date, through May 31, 2015, the FDA received 5093 medical device reports related to Essure. The majority of reports received since 2013 have been voluntary reports, mostly from women who received Essure implants.
The most frequently reported patient problems during this period were pain/abdominal pain (3353), heavier menses/menstrual irregularities (1408), headache (1383), fatigue (966), and weight fluctuations (936). Most of the reports received listed multiple patient problems in each report. The most frequent device problems reported were patient device incompatibility (941) (for example, possible nickel allergy), migration of the device or device component (482), device operating differently than expected (301), device breakage (259), and malposition of the device (133). Multiple device problems can also be listed in each report.
Seventeen of the reports received were coded as death reports. Six of these reports were mistakenly coded as death, but no death occurred. Five reports involve fetal deaths that occurred in women who became pregnant following placement of Essure. The remaining six death reports were related to a total of 4 adult deaths: one death due to Group A Strep infection post-procedure, one death reportedly due to uterine perforation during device placement, one death related to an air embolism during device removal surgery and one death from suicide. Confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report.
“These are life-altering side effects that stop you from functioning as a person,” Angie Firmalino said in a statement to the FDA.
The FDA reports it has received over 20,000 complaints regarding the product manufactured by Bayer, which defends Essure and continues to market the product to women as an alternate and permanent method of birth control.
If you believe you or a family member has suffered adverse health effects while using this implant, contact an attorney at Cellino & Barnes online today or call 800-888-8888 for a free case evaluation.