Bayer May Have ‘Actively Concealed’ Negative Essure Reports
This is attorney Michael Brady Lynch, lead trial attorney for The Michael Brady Lynch Firm.
The first Essure lawsuit was filed in Philadelphia against Bayer HealthCare. The suit accuses Bayer and original manufacturer Conceptus of intentionally misleading women implanted with Essure, which violates the conditions of premarket approval from the FDA.
Approved in 2002 for women ages 21 to 45, Essure is a soft, flexible metal spring made from a nickel-titanium alloy. Doctors offer it to women as an alternative to the invasiveness of tubal ligation. Essure typically involves general anesthesia and a laparoscopy in the doctor’s office unlike a tubal ligation, which occurs in a hospital and requires surgery. OBGYNs insert one coil into each fallopian tube. Scar tissue will form around the coil to obstruct eggs from leaving the fallopian tubes to become fertilized. Three months after the procedure, women must have a follow-up procedure involving an X-ray and dye to confirm that the tubes are fully blocked.
Bayer claims that the device is nearly 100 percent effective at preventing pregnant and is perfecting safe, however, thousands of women disagree. They allege that the metal coils have caused them serious injuries such as perforating the fallopian tube, neurological damage, autoimmune problems, hair loss and migraines along with severe pain.
In addition to the reported adverse events, a few deaths have been linked to Essure. According to the FDA, four women died from infection, uterine perforation, air embolism, and suicide. Additionally, five fetuses died from the permanent birth control. If Essure is nearly 100 perfect effective, why did a 2014 study by a Contraception journal find that nearly 10% of women who used Essure could become pregnant? This is four times the risk of pregnancy than those with a tubal ligation.
For women who want to remove Essure, they only have one option: a complete hysterectomy. Many times the fallopian tubes and uterus are too scarred and damaged to be saved. The long-term effects of having a hysterectomy are staggering (incontinence, bowel dysfunction, and pelvic organ prolapse). Since the FDA fast-tracked the approval process, they implemented a condition that the study participants had to be followed for at least five years following insertion of Essure. Only 366 of the original 618 participants were followed. Out of those 366, 15 had hysterectomies.
Bayer will not reveal just how many women in the U.S. actually use Essure, making it difficult for experts to gauge a proper risk to benefit ratio from the extended study. This usually occurs when patients are having issues a particular medical device or drug. Companies keep the positive participants and ‘lose’ the negative participants, whom experience problems.
Each year, 345,000 women in the United States undergo sterilization procedures as a form of permanent birth control. This equates to 10.3 million US women who rely on these procedures for pregnancy prevention and to above all be safe when used. Women who choose Essure as their form of permanent birth control deserve to be told the overall risks and benefits. If they knew they had a 10% chance of pregnancy or were at risk for a complete hysterectomy would they choose Essure? At the Michael Brady Lynch Firm, we believe patients should be given the facts to make an informed decision. We will fight to make sure you won’t be victimized again. If you or a loved one have been a victim of Essure, please call us at 877-513-9517.