May 3, 2016
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061 (HFA-305)
Rockville, Maryland 20852
Comments of members of the Patient, Consumer, and Public Health Coalition
on the Draft Guidance “Labeling for Permanent Hysteroscopically-Placed Tubal Implants [the Essure System] Intended for Sterilization”
As members of the Patient, Consumer, and Public Health Coalition, we appreciate the efforts of the FDA to improve the information available to women and physicians considering the Essure System for Permanent Birth Control, through a “Boxed Warning” (black box warning) and a “Patient Decision Checklist” as part of the product labeling. However, we believe that the draft guidance is not sufficient.
The purpose of the draft guidance is to ensure that women receive and understand information about the risks and benefits of permanent devices (hysteroscopically-placed tubal implants intended for sterilization). The Essure System is the only type of these devices marketed in the U.S.
We agree with the FDA that in order to make patients aware of the risks associated with the Essure System, there needs to be “accurate product labeling and effective messaging of that labeling.” We agree with FDA that a boxed warning and patient decision checklist should be included in the labeling sections of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The FDA is seeking comment on this draft guidance regarding the wording and content of the black box warning and the patient decision checklist. Our specific comments are below:
The Boxed Warning
This section of the draft guidance has two bullets. The first covers adverse events associated with the device and its insertion or removal, and the second bullet declares that a statement “noting these risks should be conveyed to the patient during the women’s decision-making process.” This short section is augmented by example of a Boxed Warning included in Appendix A of the draft guidance. The example lists several adverse events that may occur from the use of Essure.
We have two concerns about the Black box warning:
- We believe that the phrase “some patients” will be misconstrued as “not many patients.” This is not consistent with the thousands of women who have reported their problems from Essure to the FDA. We suggest you delete the word “some” or replace it with “Many” or “numerous.”
- Most patients will probably not see the device’s boxed warning. To make it clear to patients that the implants are associated with serious adverse events, the black box warning and a description of why the device has one, should be added to the Patient Checklist.
Possible text for the Patient Checklist could read:
“I understand that the Essure device has received a black box warning, which is used to call attention to serious or life-threatening risks. I acknowledge that my provider has discussed these risks with me and that I understand those risks.”
Patient Decision Checklist
We support the FDA’s requirement that physicians provide women considering Essure or similar implants with a list of risks that the FDA has found to be linked to the device.
Women can and do make good decisions about the risks and benefits of drugs and medical devices when they have good information. However, the Patient Checklist needs to be easier to understand and more succinct in order to maximize the likelihood that most patients will read and understand it.
As drafted, the Patient Checklist is too long, the language is at a level that seems designed for college graduates rather than the 6th-8th grade reading level that is recommended by health educators, and the check list emphasizes the permanent nature of the device rather than the risks of the device. In its current form, it is unlikely that most women will read more than the first few points. The checklist needs to be completely rewritten. It should also use the term “sterilization” rather than “permanent birth control.” Essure patients have advised us that the term “permanent birth control” is confusing.
Some specific language in the example checklist needs to be changed. On page 12, lines 407-411, it says: “These types of events, although not reported in clinical trials supporting device approval, have been reported to FDA by women implanted with the Essure System.” We request that you delete: “although not reported in clinical trials supporting device approval.” The inclusion of that line downplays the thousands of serious adverse events reported by women from their real world experience. For example, the National Center for Health Research study of 1104 women with Essure problems found that 86% reported pain (mostly pelvic or abdominal), 34% reported excessive bleeding (some bled every day of the month instead of a regular period), 22% fatigue, 16% hair loss, 12% hysterectomy, 12% depression, and 7% allergies. While these are not a random sample of Essure patients, they indicate the clear pattern of complications that women report. It is important to note that about 35% had Essure removed and about half of those had a complete recovery. Only 5% of those who had them removed reported no improvement in symptoms.1
In addition, it is essential that the checklist be completed at least one week prior to the Essure procedure, so that the patient is provided the information prior to scheduling the surgery or at the least at a time that she can cancel the surgery if she decides it is not a good idea for her.
Additional Research Study
We fully support FDA requiring a “clinical study for Essure to determine heightened risks for particular women.” During the 2015 FDA Advisory Committee meeting, it became clear that many women have been harmed by Essure and it is not known if the risks are higher for some subgroups of women or not.
Requiring an additional research study be conducted as soon as possible is essential so that providers and women to make more evidence-based decisions. We urge the FDA to require a study of sufficient size and inclusive of diverse populations (including women of color, women of diverse reproductive ages, body size, for example). The study as a whole and the subgroups must be of sufficient power to detect increased risks for certain women and conducted in a way that short-term and long-term complications are well-documented.
Members of the Patient, Consumer, and Public Health Coalition strongly support a Boxed Warning and a Patient Decision Checklist for the Essure Permanent Birth Control device. However, both need to be improved, and the latter needs to be rewritten to be suitable for the average reading skills in the U.S.
One final point, we are very concerned about how the FDA discusses Essure in the press. FDA made a statement on February 29, 2016 that “Essure remains an appropriate option for the majority of women seeking a permanent form of birth control” (emphasis added).2 Until better research is conducted, it is not possible to say what percentage of women or which subgroups of women are most likely to benefit and least likely to be harmed by Essure compared to other alternatives.
Breast Cancer Consortium
National Center for Health Research
Washington Advocates for Patient Safety
The Patient, Consumer, and Public Health Coalition is an informal coalition of nonprofit organizations representing the interests of millions of patients, consumers, health-care professionals, scientists, and public health experts. The coalition can be reached through Paul Brown at (202) 223-4000 or at email@example.com.
- National Center for Health Research (2015). Results of National Center for Health Research study of 1104 women with Essure. ▲
- Food and Drug Administration (February 29, 2016). FDA Media Briefing FDA Announces New Actions on the Essure Device. http://www.fda.gov/downloads/newsevents/newsroom/mediatranscripts/ucm489155.pdf ▲