September 14, 2015
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
To whom it may concern,
The American College of Obstetricians and Gynecologists (the College), a national medical organization representing nearly 59,000 board-certified obstetrician-gynecologists and partners in women’s health, appreciates the opportunity to provide comment to the Food and Drug Administration’s (FDA’s) Obstetrics and Gynecology Devices Panel. The College thanks the FDA for holding this advisory committee meeting and for its attention to the safety of hysteroscopic sterilization with Essure, as the health and safety of our patients is of the utmost importance to the College and its members.
Contraception is an essential part of women’s health; the majority of women will use birth control at some point in their lives. Female permanent contraception or tubal occlusion (also referred to as sterilization) is one of the most popular methods for women, including those who have achieved their desired family size.
In fact, 600,000 tubal occlusions are performed each year in the United States. Roughly 30 percent of married couples rely on tubal occlusion for their birth control. Overall, sterilization accounts for one quarter of contraceptive users in the U.S.
Female permanent contraception can be performed through two different routes – abdominal or transcervical – and via the use of several different technologies. However, Essure is the only technology available to perform a less-invasive transcervical tubal occlusion, which does not require general anesthesia and can be performed in a physician’s office rather than the operating room.
All medical procedures carry risks and benefits, and no single approach is right for every woman. However, a woman’s coexisting medical conditions, including obesity, cardiac or pulmonary disease, may make the less-invasive approach a safer option in some cases.
The currently available transcervical method, hysteroscopic tubal occlusion, utilizes a small camera inserted through the cervical opening, so no incisions are necessary. As noted previously, Essure is the only technology available for tubal occlusion using this approach. If placed correctly and confirmed with a follow up hysterosalpingography (HSG) or ultrasound after three months, this approach has an efficacy similar to traditional methods for tubal occlusion, and allows a women to return quickly to her normal activities.
Additionally, because the hysteroscopic approach does not require entry into the abdominal/peritoneal cavity, it may reduce the risk of injury to abdominal organs (Cicinelli 2010). For this reason, major morbidity associated with general anesthesia and abdominal surgery can be avoided. This is particularly appealing for patients with significant coexisting medical disorders, obesity, or intra-abdominal adhesions (scar tissue) from prior surgery.
Nickel allergies have been raised as a concern related to this device. It has been found that an Essure insert releases a miniscule amount of nickel each day, less than one thousandth the amount in the average daily food intake. The overall reported incidence of adverse events suspected to be related to nickel hypersensitivity in patients with Essure microinserts is extremely small (0.01%), and the incidence of confirmed nickel reactions is even smaller. This very low incidence of clinically significant reactions is consistent with data from other nickel-containing implantable devices and is reassuring (Zurawin 2011). Thus, women with nickel sensitivity are considered candidates for Essure and do not require pre-procedure confirmatory skin testing, though they should be counseled about the minute amounts of nickel (Conceptus 2012).
For a woman considering female permanent contraception, the choice of method should include a review of her medical health, her tolerance of office procedures, her ability to adhere to follow-up testing, the safety of abdominal surgery and general anesthesia, and any health insurance limitations. In addition, women should be counseled about the other options for highly effective contraception, including vasectomy for their male partner or long-acting reversible methods of contraception like the intrauterine device and subdermal implant. Although there are no set medical conditions that are strictly incompatible for a woman to undergo tubal occlusion, the safety of the option chosen (abdominal or hysteroscopic) must be assessed in the context of the woman’s medical conditions. ACOG supports access to comprehensive contraceptive care and contraceptive methods as an integral component of women’s health care and is committed to supporting policies and actions that ensure the availability of the full range of affordable and accessible contraceptive care and contraceptive methods. ACOG considers it essential that less-invasive tubal occlusion options, like Essure, remain available to women. It is critical that women have a choice when it comes to contraception.
In order to improve the use of hysteroscopic tubal occlusion in the future, we ask the FDA to take steps toward obtaining more high-quality data on its safety and efficacy – not anecdotal reports. While ACOG recognizes the value of FDA adverse event systems, we also must keep in mind that in many cases, we lack adequate evidence that the full range of adverse events being reported are caused by the device at issue.
We know that there are tools available for FDA and the medical community to better track and understand Essure use. Postmarket studies including post-placement pregnancy, ectopic pregnancy, and spontaneous abortion rates; comprehensive patient registries; and unique device identifiers will allow us to evaluate not just a patient’s insertion experience, but also her long-term response and wellness, including potential side effects and the incidence of those side effects.
As physicians who specialize in women’s health, we know that permanent contraception is of lifelong importance to women and their families. We want to understand the positive and negative impacts of this choice.
Doctors have to take a lot of information into consideration when they are discussing treatment options with women and their families. First and foremost, we must evaluate each individual patient’s medical history and needs. We also consider the information that we receive from the FDA, our own personal experience and more.
We hope that the FDA will view this conversation as an opportunity for us to improve the data available to women, to physicians, and to the agency itself.
ACOG would be happy to play a role in advising FDA representatives on the role of the ob-gyn in contraceptive counseling and on the information that will help us make decisions in the future.
- Guiahi M, Goldman KN, McElhinney MM, Olson CG. Improving hysterosalpingogram confirmatory test follow-up after Essure hysteroscopic sterilization. Contraception 2010;81:520–4. (Level II-2) [PubMed] [Full Text] ⇦
- Shavell VI, Abdallah ME, Diamond MP, Kmak DC, Berman JM. Post-Essure hysterosalpingography compliance in a clinic population. J Minim Invasive Gynecol 2008;15:431–4. (Level II-2) [PubMed] [Full Text] ⇦
- Chapa HO, Venegas G. Preprocedure patient preferences and attitudes toward permanent contraceptive options. Patient Prefer Adherence 2012;6:331–6. (Level II-3) [PubMed] [Full Text] ⇦
- Basinski CM. A review of clinical data for currently approved hysteroscopic sterilization procedures. Rev Obstet Gynecol 2010;3:101–10. (Level III) [PubMed] [Full Text] ⇦
- Cooper JM, Carignan CS, Cher D, Kerin JF. Microinsert nonincisional hysteroscopic sterilization. Selective Tubal Occlusion Procedure 2000 Investigators Group. Obstet Gynecol 2003;102:59–67. (Level II-3) [PubMed] [Obstetrics & Gynecology] ⇦
- Kerin JF, Cooper JM, Price T, Herendael BJ, Cayuela-Font E, Cher D, et al. Hysteroscopic sterilization using a micro-insert device: results of a multicentre Phase II study. Hum Reprod 2003;18:1223–30. (Level II-3) [PubMed] [Full Text] ⇦
Cicinelli E. Hysteroscopy without anesthesia: review of recent literature. J Minim Invasive Gynecol 2010;17:703–8. (Level III) [PubMed] [Full Text] ⇦
- Kraemer DF, Yen PY, Nichols M. An economic comparison of female sterilization of hysteroscopic tubal occlusion with laparoscopic bilateral tubal ligation. Contraception 2009;80:254–60. (Cost-benefit) [PubMed] [Full Text] ⇦
Zurawin RK, Zurawin JL. Adverse events due to suspected nickel hypersensitivity in patients with Essure micro-inserts [published erratum appears in J Minim Invasive Gynecol 2011;18:688]. J Minim Invasive Gynecol 2011;18:475–82. (Level III) [PubMed] [Full Text] ⇦
Conceptus Incorporated. Essure: instructions for use. Mountain View (CA): Conceptus Inc.; 2012. Available at: http://www.essuremd.com/App_Themes/BaseTheme/PDFs/Link%20Essure%20IFU.pdf. Retrieved December 12, 2012. (Level III) ⇦