Essure Birth Control Injuries Highlighted in Congressional Testimony

A woman testified on Capitol Hill last week about serious and debilitating injuries she claims were caused by the Essure birth control device, highlighting the need for medical device and drug regulation reforms.

The testimony was provided during a briefing held on Thursday by the National Center for Health Research (NCHR), which is calling for legislation to improve the FDA approval process.

As part of a program entitled “Reforming the FDA: The Impact of Proposed Changes on Patients and Health Policy”, NCHR indicated that policies should be put in place to make the approval process for drugs and medical devices more effective at weeding out unsafe products.

Kim Hudak testified about her experience as part of a small group of women who were involved in the clinical trial that led to the approval of the controversial Essure birth control in 2002.

Hudak echoed concerns about the risk of Essure birth control injuries voiced by many women who have received the implant.

According to the testimony, Hudak indicated that she was told that the device was 99% effective when she entered into clinical trials for the birth control implant in 2000. She indicates that there was never a discussion about safety issues or about the fact that the device was made of nickel and polyethylene terephthalate (PET) fibers.

“It never dawned on me that a device being tested on humans wasn’t safe. My only concern was will it work and how fast can I return to work,” Hudak said in her statement before a panel of congressional aides. “Candidly speaking, I will say the doctor did a very good job of making me feel safe and I was confident that if something did go wrong it would be addressed immediately and I would be well cared for. I couldn’t have been more wrong.”

Hudak said the Essure implantation was painful and one of the devices had to be redone. She said that by the end of the first month she began experiencing sharp pains, and it only got worse from there. She dealt with pain, aches, exhaustion and a number of other problems after the device was implanted, withdrawing from family and being diagnosed with a variety of maladies to explain her illnesses.

During all that time, Haduk said the clinical trial doctors told her it could not possibly be linked to Essure. She eventually found a Facebook group of other women who suffered from Essure complications and was able to obtain her medical records from the clinical trial.

“I was honestly shocked by what I read in those records. My information was altered to reflect that I was doing well with the coils while in fact, the entire time I was complaining of issues which were documented in the medical exam but not in the study information,” she said. “The doctor even had a clinical note explaining that she suspected a nickel allergy severe enough to warrant removal of the devices.”

Hudak said she eventually underwent a hysterectomy to have the Essure implants removed, but it was botched and she was left with PET fibers and nickel fragments in her body due to the use of a power morcellator. Hudak said it is unlikely a solution will ever be found to her health problems.

Essure Complications

Hudak is one of thousands of women who have complained about Essure injuries. The FDA has received hundreds of adverse event reports over the past decade involving problems that could be linked to the side effects of Essure implants.

The birth control implant is offered as an outpatient procedure by many medical facilities. During the surgery, a doctor inserts bendable coils into the fallopian tubes, passing through the vagina, cervix and uterus. The process thus causes scar tissue to form around the coils over several months, which blocks the tubes, preventing insemination.

Problems reportedly linked to Essure include puncturing of the fallopian tubes and uterus, allergic reactions, reports of the implants breaking inside women’s bodies and other side effects. The FDA reports alone detail nearly 100 women who have had to undergo hysterectomies due to Essure side effects.

Bayer, which bought the original company that made the Essure implant and now markets the device worldwide, has downplayed the complaints, saying that there are relatively few cases out of the Essure implants used worldwide.