Concerns are growing about the safety of the Bayer AG's Essure permanent
contraception device. The latest study found that the patients implanted
with the medical device often require additional surgeries.
The medical device consists of two small nickel-titanium coils, which are
inserted through the vagina into the fallopian tubes. First approved in
2002, Essure is touted as an alternative to surgical sterilization, or
tubal ligation. However, patient complaints regarding its safety are growing.
The latest study examined medical records of approximately 52,000 patients
from New York outpatient ambulatory surgical centers between 2005 and
2013. The researchers found that by one year after the initial procedure,
2.4 percent of Essure patients required follow-up surgery compared with
0.2 percent of those who underwent laparoscopic sterilization.
After extrapolating the data, the researchers concluded 21 additional surgeries
are needed per 1,000 patients implanted with the device. "In some
instances, these re-operations are quite major surgeries" including
hysterectomies, lead researcher, Dr. Art Sedrakyan, professor of healthcare
policy and research at Weill Cornell Medicine in New York,
Last month, the U.S. Food and Drug Administration (FDA) announced that
it was reviewing the benefits and risks of Essure in order to determine
whether restrictions or label changes are warranted. To date, the agency
has received more than 5,000 adverse reports related to the device.
Essure is also the subject of a
growing number of product liability suits that maintain the device is unsafe. Plaintiffs allege that the medical
device resulted in a range of serious side effects, such as chronic pain,
allergic reactions, migration of the device from the fallopian tubes,
bleeding, and autoimmune disorders.
If you or someone you care about has suffered serious harm due to defective
medical contraceptive device, don’t hesitate to contact
a San Diego product liability lawyer at the Law Offices of Robert Vaage
for a free consultation.