Complaints double against popular form of birth control Essure

Complaints double against popular form of birth control Essure »Play Video

VANCOUVER, Wash. -- Nicola Cook and her husband, Jack, should not have been at the Birthing Center of PeaceHealth Southwest Medical Center in Vancouver this week. But there they were, thanks to what they call an unexpected blessing: a baby.
  
"I was worried - more than I have been with any other pregnancy," Nicola said.
 
Tuesday, Nicola delivered her third child but the Cooks planned not to have this child.
 
"When you think you can't have any more kids and you planned on not having kids, and then finding out you're pregnant, it's really emotional," Nicola explained from her hospital bed.
 
Somehow, inside Nicola's womb, a baby grew next to a permanent birth control device called Essure.

During an Essure procedure, which is touted as a safer, surgery-free alternative to tubal ligations, doctors insert a metal coil into each fallopian tube. Then, over the course of three months, scar tissue builds up around the coils and is designed to block conception.
    
All of Essure's literature states the device is 99.83 percent effective.
 
Nicola had the Essure device implanted three years ago, after her first two pregnancies were marked with complications, a toll Nicola said she couldn't bear a third time. Nicola said her doctor guaranteed that she could have peace of mind from another pregnancy.
 
But last August, about three years after the procedure, Nicola had to make peace with the news of a newborn.
 
"I just think relief that I made it this far, that I didn't have problems and I didn't miscarry," she said Tuesday morning. But Nicola wasn't out of the woods yet. With just hours to go before the birth, she still feared what effects the Essure coils could have on her new baby.
 
"It is completely uncharted," Nicola said. "(Doctors) didn't know what was going to happen."
 
The On Your Side investigators uncovered a growing number of complaints about Essure. In November, KATU uncovered 943 women, doctors and other people had filed complaints with the Food and Drug Administration (FDA).

Since that report, KATU individually counted each complaint and found the numbers through the month of March (April was not available) jumped to 2,049. The FDA did not provide an official number.

The new complaints match the old: excruciating pain, extreme bloating, skin rashes, broken coils inside the body and other unexplained symptoms, which many women believe are from the nickel and other fibers in the coils.
 
One complaint, dated Nov. 11, 2013, states: "I have been suffering from chronic pelvic pain, heavy bleeding, abdominal pain, rashes, dizziness, ut infections, headaches, bruising, tingling in hands and legs, itching every where, nausea, blurry vision, dry eye socket, hot flashes, muscle weakness, brown spots under breast and on arms, lower back pain."
 
"With every day, it seems that the side effects are getting worse and the diagnoses are getting worse," said Michelle Garcia, Essure victims' advocate.
 
Garcia is a mom in Miami who describes herself as an Essure victim turned outspoken activist.
 
"It's life altering to know there's a day on the calendar where I could have died," Garcia explained about the day that she hemorrhaged and had to go to the hospital. Garcia blamed her bleeding, mysterious aches and pains and other symptoms on Essure. She's evolved in a self-described fearless leader of Essure sisters across the nation and world.
 
"I don't care who I piss off to get the message across that this device is dangerous and this device needs to be off the market, period."
 
Garcia's one of 10 women running the rapidly-growing Facebook page Essure Problems. Created in 2011, the page now has more than 7,000 members.
 
'Our Facebook page is a support group for women and their families who've been injured by Essure," Garcia said.

Among the members are women like Shannon McOsker. Remember her? The On Your Side Investigators first shared her story in November. At that time, she and several other "E-sisters" she met through the Essure Problems Facebook page spoke about how they had surgery to get their coils out.

"Mid-cycle, they would feel like there's a curling iron in my tube," McOsker said, describing the feeling of the coils in her body.
 
But when doctors went in for Shannon's surgery, they made a startling discovery: a coil punctured one of her fallopian tubes.

Then, another shocker. McOsker's post-operative report shows the Essure implant broke into two pieces.

At that time, McOsker was wrestling with the idea of more surgery to remove the remaining coil pieces. And that's ultimately what she did -- she made the grueling decision to have a hysterectomy so she could be completely coil-free.
 
Garcia told KATU that surgery is an increasingly common recourse for women implanted with Essure, especially since she insists that many doctors, the FDA, and Bayer -- Essure's parent company --- largely turn a blind eye to their concerns.
 
"We've written to countless levels at the FDA," Garcia said.
 
It's why, on April 29, Garcia is flying to Germany for a Bayer Stakeholders' conference to try to convince the company to take the device off the market.
 
"Enough is enough," Garcia said.
 
In the last year, consumer advocate Erin Brockovich. She started her own website for women who had the Essure procedure, so they could share their stories and concerns as well as initiate change.
 
Back at the hospital, after a relatively quick delivery -- it was so quick, doctors had no time to administer an epidermal -- Nicola and Jack welcomed a healthy baby boy.

"Oh, come here buddy," Nicola cooed, swaddling him in a blanket and holding him to her chest.

The Cooks named him Colin James Mitchell.

An unexpected blessing.
 
"It's like, 'Yeah you weren't planned buddy, but you're pretty loved!'" Nicola said.

Statement from Bayer:
 
Bayers Associated Director of Communications, Tara Camp, sent the On Your Side Investigators this statement:
 
At Bayer, our mission is to create medicines and devices that help people.  We have great sympathy for anyone who is experiencing pain, regardless of the cause. We have also read the stories from women who are sharing their personal experiences with Essure. These stories, while compelling, are not representative of the hundreds of thousands of women who have relied on Essure for the past 10 years since its FDA approval.
 
As the manufacturer of this product, we have a responsibility to share the facts about Essure:
• Most of the adverse events that have been reported recently about Essure are known and have been in the Essure product label. This has been confirmed by the FDA which found that "[a]lthough there is evidence of complications, as there are with all medical devices, overall results from [a five year safety] study did not demonstrate any new safety problems or an increased incidence of problems already known."1 (<http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/ucm371014.htm>)
 
• Essure has more than a decade of research and development in addition to a decade of real world experience.  More than 750,000 devices have been sold worldwide.  Essure has been shown to be highly efficacious (99.83% based on a 5 year study) and the safety profile has been documented through clinical trials. The American College of Obstetricians and Gynecologists (ACOG) has recognized that "hysteroscopic tubal occlusion for sterilization has high efficacy and low procedure-related risk…."2
 
• More than 600,000 tubal ligation procedures are performed in the United States each year.3  We stand by the benefit-risk profile of Essure as an important option available to women who want permanent contraception.
 
No form of contraception is without risk, should be considered appropriate for every woman or is considered 100 percent effective. It is important that women discuss the risks and benefits of any birth control option with their physicians.
 
Essure is a permanent birth control procedure that works with your body to create a natural barrier against pregnancy.
 
Important Safety Information
 
WARNING: You must continue to use another form of birth control until you have your Essure
Confirmation Test and your doctor tells you that you can rely on Essure for birth control.
• You can rely on Essure for birth control only after your doctor has reviewed your Essure Confirmation Test results. Your doctor will confirm that the inserts are properly placed and both of your fallopian tubes are blocked. If you rely on Essure for birth control before having your Essure Confirmation Test, you are at risk of getting pregnant.
• Talk to your doctor about which method of birth control you should use for the 3 months after the procedure. Some women can remain on their current birth control. Other women, such as those using an intrauterine device or contraceptive (IUD or IUC), will need to switch to another method.
• It can take longer than three months for the Essure procedure to be effective. In rare cases, it has taken up to 6 months. Make sure to continue using an alternate form of birth control up until your doctor has reviewed your Essure Confirmation Test results and confirmed that you can rely on Essure for birth control.
 
WARNING: Be sure you are done having children before you undergo the Essure procedure. Essure is a permanent method of birth control. The younger a woman is when she chooses to end her fertility, the more likely she is to regret her choice later.
 
During the procedure: You may experience mild to moderate pain, your doctor may be unable to place one or both Essure inserts correctly, part of an Essure insert may break off or puncture the fallopian tube requiring surgery to repair the puncture, or your body may absorb a large amount of the salt water solution. Your doctor may recommend a local anesthesia which numbs the cervix. Ask your doctor about the risks associated with this type of anesthesia. Immediately following the procedure: You may experience mild to moderate pain and/or cramping, vaginal bleeding, and pelvic or back discomfort for a few days. Some women experience nausea and/or vomiting or fainting. In rare instances, an Essure insert may be expelled from the body.  During the Essure Confirmation Test: You will be exposed to very low levels of radiation, as with most x-rays. In rare instances, women may experience spotting and/or infection.
 
Long-term Risks: There are rare reports of chronic pelvic pain in women who have had Essure.  In rare instances, an Essure insert may migrate through the fallopian tubes into the lower abdomen and pelvis. It may be necessary to surgically remove the migrated device if the patient is experiencing an adverse event.  No birth control method is 100% effective. If you do become pregnant after Essure, the risks to you, the fetus, the pregnancy and childbirth are unknown. Women who have the Essure procedure are more likely to have an ectopic pregnancy if they get pregnant. Ectopic pregnancy is when the pregnancy occurs outside of the uterus. Ectopic pregnancies can be very serious or life-threatening. If you have the NovaSure® procedure, a procedure that removes the lining of the uterus to lighten or stop menstrual bleeding, after the Essure procedure, your risk of pregnancy may increase. The Essure insert is made of materials that include a nickel-titanium alloy. Patients who are allergic to nickel may have an allergic reaction to the inserts. Symptoms include rash, itching and hives.
 
Unknown Risks: The safety and effectiveness of Essure has not been established in women under 21 or over 45 years old. The safety and effectiveness of reversing the Essure procedure, of in vitro fertilization (IVF) after the procedure, or to you and your fetus if you get pregnant after the procedure are not known.
 
Adverse Events: During the procedure, the most common problem reported was mild to moderate pain (9.3%).  Some of the women in the study reported moderate pain (12.9%) and/or cramping (29.6%) on the day of the procedure. A smaller percentage of women reported nausea/vomiting (10.8%) and vaginal bleeding (6.8%).
 
Essure inserts do not protect against HIV or other sexually transmitted diseases.
 
Talk to your doctor about the Essure procedure and whether it is right for you.

Q&A with the FDA spokeswoman Jennifer Rodriguez:

Is the FDA considering pulling Essure off the market?

The FDA has reviewed Essure patient reports of problems (including web-based testimonials) and adverse event reports submitted to the FDA from a variety of sources, including doctors, patients, and the manufacturer of Essure, Conceptus, Inc. The agency also reviewed the results from the five-year follow-up post-approval study conducted by Conceptus that was required by the FDA as part of the product’s 2002 approval. In addition, the FDA evaluated the available clinical literature to determine what long-term complications may be associated with Essure. To date, there is no literature reviewed by the FDA that has indicated any new or more widespread complications definitely associated with Essure occurring more than five years after Essure placement. (Because the FDA had up to five year follow-up data from the post-approval study, the literature review concentrated on evaluating long-term complications more than five years after placement.)
 
The FDA takes reports of problems with Essure very seriously and will continue to review them carefully. We will continue to monitor the safety of Essure to make certain that it does not pose an increased risk to public health and safety and that its benefits of providing women with a non-surgical sterilization choice continue to outweigh the risks of the device.
 
As the number of complaints about Essure continues to rise, is the FDA getting any more concerned about the product’s safety?

The FDA relies on a variety of postmarket surveillance data sources to monitor the safety and effectiveness of medical devices. Adverse event and product problem reports submitted to the FDA are just one source we use to monitor marketed medical devices, and these reports may contribute to the detection of potential device-related safety issues as well as to the benefit-risk assessments of these devices. While such reports are a valuable source of information, this type of reporting system has notable limitations. For example, complaints or adverse event reports do not necessarily directly indicate a faulty or defective medical device, and adverse event reports alone cannot be used to establish or compare rates of event occurrence, such as pregnancies. For these reasons, the FDA also evaluates other information to make decisions about a device’s safety and effectiveness once a device is on the market, including post-approval studies and review of the clinical literature.
 
Please see above response and the website I provided earlier for information regarding the FDA’s review of reported problems. The FDA has not found a direct, causal connection between the use of Essure and certain adverse event reports.
 
The FDA takes reports of problems with Essure very seriously and will continue to review them carefully. We will continue to monitor the safety of Essure to make certain that it does not pose an increased risk to public health and safety and that its benefits of providing women with a non-surgical sterilization choice continue to outweigh the risks of the device.