Nowadays, women in the Houston area have countless options when it comes
to deciding their family size. While women of generations past generally
had to rely on birth control pills for family planning, today there are
more options and many different types of contraceptives. Since women rely
on these medications or devices to prevent pregnancy, there can be dangerous
pregnancy-related injuries if the products are compromised in any way.
Women who use the contraceptive Essure may be interested to know that a
television news team in another state recently reported on their investigative
findings concerning the device. Apparently, when Essure was manufactured
by the company Conceptus, the U.S. Food and Drug Administration cited
the makers for failing to report complaints about the product in a timely
manner. As a result of two different inspections, one in 2003 and another
in 2010, the FDA issued Form 483s, which are issued when an investigator
observes findings that point toward a company’s violation of FDA regulations.
Unlike birth control pills, Essure is a form of permanent birth control.
However, unlike some other devices, Essure does not require surgery for
implementation. Coils made of metal are put inside a woman’s fallopian
tubes, which are supposed to allow scar tissue to build up in the tubes
and block the process of conception. Many problems with the process have
been reported, from chronic pain in the pelvic region to rashes and bloating.
The more severe effects have included ectopic pregnancies, miscarriages
Essure is now owned by a different company, Bayer HealthCare, which purportedly
has not received any Form 483s from the FDA since they purchased Essure
last year. Still, according to media reports from 2013, women have continued
to come forward with complaints about the device and many have stated
they want the device off the market.
If a birth control device fails, despite being used as directed, a woman
may face horrendous long-term consequences. If a woman doesn’t know
she is pregnant, she may drink alcohol, smoke or otherwise partake in
habits that can be harmful to a fetus. At the same time, an unexpected
pregnancy can push a woman or couple into making decisions that they never
thought they’d have to make. Women who believe they may have been
harmed by a manufacturer’s negligence may wish to speak with an experienced
Houston malpractice attorney for information about their legal options.