|Erin Brockovich Leads Fight Against Birth Control Procedure|
|By KEVIN DOLAK (@kdolak)||Oct 10, 2013, 2:21 AM|
A popular and permanent form of birth control that hundreds of women say is causing severe adverse reactions has now become the latest cause of famed consumer advocate Erin Brockovich, who has launched a grassroots campaign against the procedure.
Brockovich, who in 1993 led a multimillion-dollar groundwater contamination case against Pacific Gas and Electric Co., has launched a campaign to have the Essure procedure taken off the market of birth control options. Brockovich told ABCNews.com that she first heard of the product about a year ago, and after hearing an increasing number of horror stories launched the campaign and online petition for women to share their stories about Essure, inform each other and initiate change.
"There's something wrong with the device, in my opinion," Brockovich said. "It's a form of permanent birth control, and women's organs are being perforated … It's ridiculous that at any level we try to defend this. If 30 women did suffer harm for unknown reason, we'd investigate. We have thousands injured. I don't think it's safe."
Brockovich said she has no financial stake in the outcome of this campaign.
Essure is a non-surgical transcervical sterilization procedure that was approved by the Food and Drug Administration in 2002, and is meant as a cheaper, easier and safer alternative to tubal ligation.
During the outpatient procedure, bendable coils are placed into the fallopian tubes, passed from the vagina through the cervix and uterus. Scar tissue then forms around the coils and blocks the tubes from insemination, according to marketing literature provided by the manufacturer.
Brockovich is calling for Essure to be taken off of the market by Bayer, who owns Essure, and is seeking a complete investigation into injury claims.
"[Bayer] should care about the health and welfare of all people," she said. "Especially women and children in this country. If this many are reporting injuries, take it off the market. It's not working. These women were misled. They feel they were scammed."
Brockovich also points to the fight against so-called contentious preemption laws, which exempt product manufacturers from tort claims for products that the FDA has approved. When the FDA approved Essure in 2002, it gave the device preemption status.
"Preemption is not about the Essure women – it affects all consumers," she said. "If someone had a medical device installed, there's no recourse for victims, and the company is protected. If there's a problem, the company gets a pass, because they have preemption. It dawned on me the consumer didn't know. The women didn't know that this existed."
More than 700,000 women have undergone the procedure, according to Conceptus, which originally designed and manufactured Essure. Over 800 women have filed adverse event reports with the FDA about Essure birth control since 2004, according to the FDA website. In August, a woman who was admitted to the hospital with abdominal pain after having the Essure procedure died from streptococcal toxic shock syndrome, though the attending physician ruled that the cause of death was not directly related to the Essure inserts or procedure.
In addition to Brockovich's site, a number of groups have popped up on social media dedicated to sharing experiences with Essure. The unverified reports include claims of extreme abdominal pain, excess bleeding, rashes and bloating, to having to have internal organs removed.
Joleen Fuller told ABCNews.com that she decided to have the Essure procedure after having her fourth child. Though she was initially wary, she decided after some research and speaking with her obstetrician to go ahead with the outpatient procedure, mainly because it was touted to have minimal downtime and would fit into her busy schedule. But the decision, she said, ended up being a major mistake, and her ordeal began almost immediately after the procedure in April 2012.
"My cramping gradually progressed, and it kept getting worse. It's like having a daily period, like you're preparing for labor -- the contractions of labor pains," she said. "Any physical movement would make the cramping worse. I couldn't clean, I couldn't play with the kids, and I couldn't lose my baby weight. Stress made the pain worse. It was unbearable."
According to Fuller, she was born with two uteruses -- a condition she said that her doctor was aware of – and was told by doctors after the procedure that everything was fine, even though she was in extreme pain. One doctor even wiggled an Essure coil in her face and told her that something so small couldn't be causing her pain, she said.
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.