PHOENIX, Az. - Fifteen years ago, Kimberly Lira joined a clinical trial for a birth control device called Essure: a tiny spring-like device placed in the fallopian tubes to prevent pregnancy.
The idea was that with placing the coil, the tubes would scar over. The result is much like a tubal ligation (tubes tied) without the downtime associated with surgery.
However, as soon as she had her coils implanted, Lira says she felt something was wrong.
"Words can't even describe how horrible it makes me feel,” Lira said, describing the bloating and pain she says she experiences every day.
Lira said she reported those symptoms to nurses during the clinical trial. She also requested to have the coils removed.
“I was crying. I told them I wanted them taken out, and they told me that there was no reversal. This is permanent,” Lira said.
Health records: "Shocking and upsetting"
Recently, Lira requested her records from the women’s clinic where she underwent the study. When she received those documents, she said what she read shocked and upset her.
“I noticed there were things crossed out and someone else's initials on there on quite a few things. And I consider that falsifying my documents,” Lira said.
Lira noted where she reported extreme pain, the word “extreme” was crossed out. The records rated her comfort level as excellent. She also found a letter in her file showing she was withdrawn from the study just days after she requested the coils be removed from her body. The records stated she was “lost for follow up” – something she says is inaccurate.
Lira also is upset that Conceptus, the former manufacturer of the product, stated to the FDA that no one had asked for the device to be removed.
“The stress that I get to look through those, it’s crazy. It makes me very emotional to look through them,” Lira said.
Lawsuit filed in federal court
Attorneys hope Lira’s case and others who have noticed inaccuracies in their records will help a lawsuit already filed in federal court. The FDA approved Essure under its most stringent process and so, under federal law, patients cannot sue the manufacturer unless that can prove the company misrepresented its product to the FDA.
Essure is now owned by Bayer, who purchased Conceptus in 2013. Since that time, Bayer has been working to study and double check the research turned in by Conceptus. So far, their research has shown the product is safe for women. However, the company says the product does have some adverse side effects, and women need to discuss these with their doctors to make sure Essure is right for them.
Dr. Edio Zampaglione from Bayer told 41 Action News he has not had the opportunity to review Lira’s complete file. However, he has reviewed another case attached to the lawsuit. The same information was attached to a citizen’s petition recently turned over to the FDA.
Zampaglione said the file he reviewed was transparent and accurately notated. He agreed that items were crossed out but said that they were changed in the acceptable manner: crossed out and initialed. He told 41 Action News he strongly objects to any suggestion that the record were falsified.
Over the phone, he told 41 Action News from his review of the records he certainly didn’t get a picture of a “100% adverse free experience.”
Local women who used Essure watching arguments
Meanwhile, women who have had Essure in Kansas City are closely watching how the arguments over these documents plays out. They’re pleased the FDA recently agreed to take a second look at their concerns.
“It has taken quite a while and thankfully the lawyers for the group have done a lot of work, done a lot of research, turned in a lot of information,” said Jeannie Esther, who had her coils removed last year.
She and two other women we interviewed say they feel much better after having the Essure coils removed.
“We feel like ourselves again,” said Autumn
Lira says she wishes she could be pain free as well.
“I would love it. I would love to know who that Kim is. I would love to know who I could be,” Lira said.
Bayer, the manufacturer of the device, provided us a statement. Here it is in its entirety:
At Bayer, our mission is to create medicines and devices that help people. Patient safety is our top priority, and 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 since its FDA approval in 2002.
As the manufacturer of this product, we have a responsibility to share the facts about Essure with you and your viewers:
We take all adverse events seriously. Most of the side effects that have been reported recently about Essure are known and included in the Essure Instructions for Use information. This was 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] study did not demonstrate any new safety problems or an increased incidence of problems already known.” None of the information the FDA reviewed from the manufacturer safety database, the 5 year study, and available clinical literature established a causal connection between Essure and certain reported problems such as extreme fatigue, depression and weight gain. For further information on FDA’s position on Essure, please click on:
Essure has more than a decade of research and development in addition to a decade of real world experience. Based on the total units sold since launch, approximately 750,000 women worldwide have had Essure placed. Essure has been shown to be highly effective in preventing pregnancy (99.83% based on five-year clinical study data) and the safety profile has been documented through numerous clinical trials. The American College of Obstetricians and Gynecologists (ACOG) has recognized that “hysteroscopic tubal occlusion for sterilization [Essure] has high efficacy and low procedure-related risk….”
More than 600,000 tubal ligation procedures are performed in the United States each year. We stand by the benefit-risk profile of Essure as an important option available to women who want non-surgical permanent contraception.
Bayer conducts hands on training with physicians across the United States and provides ongoing support in the appropriate use of Essure. In addition, trained Bayer medical specialists conduct continuous outreach to healthcare professionals in order to learn more about how Essure is used in their practice and to answer their questions.
As we noted during our discussion, the Citizen’s Petition regarding Essure was submitted to the FDA by a law firm that has filed several Essure product liability lawsuits naming Bayer as a defendant. The allegations made in the Citizen’s Petition are similar to those stated in the lawsuits and Bayer strongly disagrees with these allegations. FDA has closed the petition and because they deemed it to be a trade complaint, forwarded it to the Office of Compliance within the CDRH. While we cannot speculate on any next steps by the agency, Bayer will respond to any questions that the agency may have. Bayer strongly disagrees with the allegations made by the law firm behind the Citizen’s Petition.
In reference to your question regarding the allegation of altered clinical data in the Citizen’s Petition, although we cannot discuss individual clinical trial participants, we have seen the materials submitted with the Citizen’s Petition and strongly disagree with those allegations. Based on good clinical practice (GCP), it is not uncommon for investigators to make edits prior to finalization on investigational reports.
No form of contraception should be considered appropriate for every woman. No form of birth control is without risk or 100 percent effective. As with any medicine or device, it is important that women discuss the benefits and risks of any birth control option with their physicians.