Erin Brockovich Leads Fight Against Birth Control Procedure Essure


Doctors weren't able to fully understand what was going on with Fuller until February, when she decided to have a hysterectomy – the very procedure she was initially trying to avoid. She said doctors discovered that a misshape in her fallopian tube caused one of the coils to shoot into her uterine wall. she said. During the hysterectomy, the coil was removed.

Fuller was able to recover after the surgery, but she says the entire process caused a year of pain, suffering and depression that she believes was unnecessary.

According to Bayer, Essuret has a well-documented benefit-risk profile, with over 400 peer-reviewed publications and abstracts supporting Essure's safety, efficacy and cost-effect.

The summary of safety and effectiveness for Essure states that 745 women participated in a clinical study for the product. According to the summary, 2.9 percent of participants experienced perforation of the uterus and 0.5 percent experienced expulsion of the device. The study states that the most common claims were moderate pain, cramping and vomiting "during the procedure."

The summary stated that 3.9 percent of participants experienced abdominal pain and cramps within the first year, while 9 percent reported back pain and 1.3 percent experienced gas or bloating. The summary also states that pregnancy and perforation of internal bodily structures other than the uterus and fallopian tube are all potential adverse events that weren't observed during the study.

Essure packaging warns women against having the procedure in circumstances including "an unusual uterine shape."

So why was Fuller given the green light to undergo the procedure? She feels that there is a lack of education about the product.

"The medical community doesn't know how to deal with this," she said. "They're not educated, the company is not educated. They're not educating the doctors. My problem was ignored."

Essure was originally designed and manufactured by Conceptus, but pharmaceutical giant Bayer paid $1 billion to acquire the company earlier this year.

In a statement released to ABC News, Bayer's spokeswoman Rosemarie Yancosek said that the company cares about patients and takes the safety of our products very seriously, and said that women should discuss the risks and benefits of any birth control option with their physicians.

"We are saddened to hear of any serious health condition affecting a patient using one of our products, irrespective of the cause," she said in a statement. "No form of birth control is without risk or should be considered appropriate for every woman."

Bayer notes in its statement that a recent practice bulletin issued by the American College of Obstetricians and Gynecologists has "recognized that hysteroscopic tubal occlusion for sterilization has high efficacy and low procedure-related risk, cost, and resource requirements."

Dr. Jennifer Ashton, senior health contributor for ABC News, was trained in the procedure when Essure hit the market in 2002. She says that she has opted not to perform the procedure on her patients because there are other forms of permanent birth control that are lower risk and higher benefit.

"Whenever there is the permanent placement of a foreign body -- in this case, metal coils -- inside the body, there is the potential for chronic pain," Ashton said. "Because Essure does not offer any known benefit towards risk reduction of ovarian cancer, as a tubal ligation does, I feel that other forms of permanent birth control are better and safer, including male vasectomy.

"Women considering permanent birth control should be offered all options including tubal ligation and male vasectomy, not only the procedure that a woman's doctor is able to perform personally," she said.

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