This article describes FDA approval of transvaginal ultrasound (TVU) as an alternative test method to confirm the proper placement of the Essure permanent contraception device. The test, like the currently used hysterosalpingogram (HSG), must be performed three months after placement of the device. The announcement by Bayer Healthcare, and Reuters’ incurious report on the announcement, do little to inform readers about the risks associated with the device and how the TVU procedure might reduce those risks. As we recently noted in a review of a Bayer Healthcare news release that reported on the tardy post-market safety assessment of Essure, numerous harms have been reported by women implanted with Essure. Improper placement of the device is a factor contributing to those harms. But there is no explanation in the article about the difference between HSG and TVU in terms of costs, benefits or harms. And there is no discussion of the evidence that led to the FDA approval.
This permanent birth control method has been the subject of more than five thousand complaints from women and health care providers describing serious harms and side effects. The FDA is expected to discuss data related to Essure’s safety and effectiveness at a public hearing in September 2015 “to inform recommendations and next steps about Essure.” Quality health journalism can help elevate the public discussion about this device — but reports that merely parrot incomplete company news releases provide little benefit to readers.
The article does not mention the cost of a TVU or whether a separate charge will be applied for this procedure. In general, TVUs can be costly if not covered by insurance. Depending on the insurance status, who does it, or where (geographically) it is done, the procedure could cost between $250-1,000. It is in interesting to note that the cost of a HSG is typically higher (can be anywhere between $800-3,000).
The article raises questions on how the TVU improves outcomes for women undergoing Essure device placement. How is the test an improvement over HSG, the current test? Though invasive, as suggested by its name (transvaginal), the procedure is less involved, invasive and painful than a HSG (which requires the injection of dye directly into the cervix/uterus — and which frequently causes pain and cramping). However, this fact is not mentioned in the report at all. Also not mentioned is the benefit of using ultrasound to minimize exposure to radiation vs. the x-rays needed for an HSG (which do emit radiation). Readers are not given any description of the potential benefits of TVU over HSG, or how they compare vis-a-vis the visualization of Essure placement. Was there a study that looked at the accuracy of TVU in determining the correct placement? And if the device is found through TVU to be improperly placed, or it’s determined through the exam that the device has broken or migrated, what are the next steps?
Harms of TVU are not addressed. Unlike the HSG, TVU does not emit ionizing radiation, which could potentially make it safer. However, some women do not tolerate TVU, which can last 45 minutes long, well. In addition, as the news release (but not the Reuters story) acknowledged, some women experience spotting or infection following a TVU test.
The article does not describe any evidence from a study that the FDA relied on to determine the appropriateness of TVU as an alternative test for verifying the Essure device has been placed properly. Were there any head-to-head comparisons on the accuracy of determining proper placement between the two methods? There is no mention of any patient-preference studies.
The news release, upon which this story is based, states that if the TVU is inconclusive as to proper placement, an HSG will need to be performed. The news release further states that a physician will determine which test to use initially — TVU or HSG.
The article doesn’t engage in disease mongering. It describes the test as an approved alternative to HSG to determine proper placement.
The story is little more than a re-worked news release. It alludes to the announcement made by Bayer Healthcare. None of the other statements of fact are attributed.
This story would have benefited from feedback from an independent expert, who could have explained the harms associated with the device and helped readers understand whether or not a new test might help improve outcomes for patients electing to undergo the Essure procedure.
Reporters needing to find independent voices for their stories are invited to refer to an extensive list of experts maintained by HealthNewsReview.org. All of these experts are free of industry ties and sensitive to reporter deadlines.
The story states that modified hysterosalpingogram (HSG) is generally used to check for proper placement of the Essure device and that TVU is a new approved alternative. However, neither the story nor the release that triggered the story explains how or why TVU might be an improvement over HSG or why one would choose one method over the other. That’s the central subject of the story so the omission of this information is a critical deficiency.
There seems to be one study (in Spanish) that assesses the use of TVU for placement vs HSG. It was not referred to in this news release or the article, and its conclusion states, “However, our study cannot replace the hysterosalpingography as gold standard.”
There is one trial registered looking at the efficacy of TVU (sponsored by Bayer) that states “This study is ongoing, but not recruiting participants.” There are no references to this ongoing trial.
The bottom line: there were no references to any studies or any reports that led the FDA to make this decision.
TVU is an established imaging technique and procedure, carried out by both ob-gyns and by radiologists (and in some cases ultrasound technicians). The requirement for additional training and certification is a bit curious. But since one can gather from the story that the procedure is widely available, we’ll award a Satisfactory rating here.
The story establishes that the TVU test has been approved by the FDA to confirm proper placement of the Essure device. Though we’ll award a Satisfactory rating on that basis, we’d note that the story doesn’t provide any background about the test or inform readers that the test itself isn’t new at all. Nor does it provide any evidence, data, or rationale for why this is advantageous over the HSG (cost? safety? availability? accuracy? comfort?).
This story is an example of one that relies excessively on a news release. There are no sources named other than the device maker, no interviews and no effort to show the test benefit or how an alternative test might improve outcomes. Sections of the story have only been marginally rewritten from the news release. For example:
Story: All physicians who offer Essure are expected to be trained to perform the TVU confirmation test by mid-2016, the company said.
News release: All physicians who offer Essure are expected to be trained and certified on the TVU confirmation test by mid-2016.