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Women suffering from the life-altering side-effects of Essure may now require a hysterectomy
Permanent birth control device Essure will no longer be sold in the United States. After battling thousands of complaints and lawsuits, manufacturer Bayer announced at the end of July that it would cease its distribution in the U.S., the final major market to close any and all use of the controversial coils. Previous markets including Canada, the United Kingdom, Finland and The Netherlands stopped allowing Essure to be used, and France and the Ukraine also had a moratorium in place for the device.
Essure Statement from Scott Gottlieb, Food and Drug Administration Commissioner: “Essure is estimated to have been used by more than 750,000 patients worldwide since it was first approved by global regulatory authorities. The device has been associated with serious risks including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen.”
The suffering caused by Essure led many women to choose surgical removal of the device. In some cases, the coils could be viewed on imaging and surgeons felt they could be safely removed via tubal ligation. However, many of the women who complained of pain or bleeding also had coils that wandered beyond their initial placement. Some coils perforated the tubes or the uterus, and some were found in areas within the pelvic cavity. In many cases, hysterectomy was one of the safest ways to ensure the coils could be completely removed. For women who wished to file complaints against Bayer, it was recommended that the uterus and fallopian tubes be removed intact so that the pathology could be used in their claim.
Given the unpredictability of the coils, laparoscopic hysterectomy in the hands of a surgical specialist may be the necessary method of removal for women across the U.S. who continue to suffer from the side effects of the device. This minimally invasive approach can reduce the trauma from surgery, which can often exacerbate the pain women are already experiencing.
Essure Problems Arose Quickly
Per instruction by Bayer, the coils were inserted into a woman’s fallopian tubes through the vagina during a visit to a doctor’s office or Planned Parenthood facility. The coils are made of a nickel-titanium alloy, and the claim by the initial manufacturer Conceptus and subsequently Bayer, was that the scarring created by the insertion into the fallopian tubes would permanently block the fallopian tubes preventing sperm from reaching the ovaries. Medical professionals trained by the company in using the catheter to insert the coils were expected to be able to perform the procedure without any incisions. Until more and more women came forward with their stories, clinics like Planned Parenthood which are non-surgical facilities, often pushed Essure as a non-surgical option for women who wanted a permanent solution to birth control.
For Many Women, The Damage Is Done
The side effects that resulted from negative reactions to Essure ranged from gynecological to autoimmune with a range of symptoms that were in many cases confusing and life-altering. Allergic reactions to the nickel in the coils created systemic inflammation. In many cases, the reactions were so severe and seemingly unrelated that it took a long time to connect the dots. To this day, despite the vast number of devices that have been placed, it’s impossible to get an exact estimate of women who have had negative reactions, because they and their physicians may not associate existing symptoms to the device.
The founder of Essure Problems, Angie Firmalino experienced a bad reaction immediately, and even after having a procedure to remove the device two years after the initial placement, she continued to have an autoimmune response that led to a persistent headache for years, and a degeneration of connective tissue affecting her joints. During the removal procedure, the coil was stretched and fragments of Essure remained in her pelvic cavity, continuing the decline in her health. The continued exposure to the fragments from the device created long-term, potentially permanent health problems that even after having a hysterectomy to remove the remaining particles has not given her any relief. As she continues to manage the pain, she was also the driving force behind petitioning the FDA to take a deeper look at the array of complications that women experienced as a result of Essure.
In other women the experiences were shocking. Teeth fell out, hair fell out, some women experienced constant bleeding or constant pain; the list is extensive. Despite its claim of providing permanent birth control, there have been more than 800 failed pregnancies after the Essure coils were inserted. Women who didn’t want to have children then faced the sorrow of burying them.
Laparoscopic Hysterectomy Can Remove Essure Completely Intact
“Expert removal of Essure is essential for helping women recover from the negative side-effects of the controversial device,” said Paul MacKoul, MD. “The coils are fragile and can shatter, leaving portions of the device in the pelvic cavity. They must be removed intact. The recommended procedure for removal is a laparoscopic hysterectomy, which allows the surgeon to remove the affected tissue and prevent damage to coils that may have migrated. If surgeons attempt to remove only the fallopian tubes and the coils are broken, the remaining fragments can continue to cause inflammation.”
In the film The Bleeding Edge, a documentary available on Netflix, medical imaging showed that in some Essure patients, if the coils were not placed properly, the medical professional administering them often placed additional coils until they were in the correct location. Due to the nature of the design, the first rounds of coils could not be removed if they were inserted incorrectly. In some cases, patients had up to eight coils placed, when they were only supposed to have two.
Medical Device Pre-Market Testing Standards Must Be Raised
“It is essential that medical devices brought to market have a stronger pre-market evaluation,” said Dr. Paul MacKoul. “Unlike pharmaceuticals which require two large studies and a strict review protocol by the Food and Drug Administration prior to being allowed into the U.S. market, medical devices are only required to have one study and the number of people in that study has a very low threshold. Similarly, devices like the power morcellator came on the market to make removal of tissue like fibroids and enlarged uteri more accessible through laparoscopic techniques, but the risks to patients with undetected cancer were only revealed once it was on the market.”
Advancements in technology has created a surge in the use of medical devices over the past 20 years. Devices are growing faster than pharmaceuticals in terms of revenue, so there is more power behind this vertical of healthcare. However, vast numbers of people are affected by medical devices that are not adequately tested, setting the foundation for an overhaul of the FDA review and approval process.
According to The Bleeding Edge, it is apparent that many physicians are unaware of the minimal scrutiny required to bring a medical device to market, instead relying on the weight of an FDA stamp of approval. However, the medical device approval process currently does not meet standards set in other approval processes, thus diminishing its credibility.
“Medical professionals require many sophisticated as well as rudimentary tools to perform their jobs, said MacKoul. “The quality of those tools must meet with stricter governance to ensure the medical community can perform their jobs without the ghost of under-tested, under-proven medical devices hanging above their heads. The ever-expanding desire to innovate and develop new technologies with the underlying intention of improving healthcare and ultimately the wellbeing of the human race must be met head on with the same scrutiny as bringing any drug to market.”
CIGC is dedicated to providing information and materials for women to help navigate the complicated healthcare system. CIGC minimally invasive GYN surgical specialists Dr. Paul MacKoul, MD and Dr. Natalya Danilyants, MD developed their advanced GYN surgical techniques using only two small incisions with patients’ well-being in mind. Book a consultation at The Center for Innovative GYN Care or call 888-787-4379.