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Transvaginal ultrasound to confirm placement of Essure device: Story based on a Bayer news release offers little information of value

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2 Star

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FDA OKs second test to see if Essure contraceptive is placed right

Our Review Summary

logo-essureThis 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.

 

Why This Matters

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.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

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).

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

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?

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

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.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

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.

Does the story commit disease-mongering?

Satisfactory

The article doesn’t engage in disease mongering. It describes the test as an approved alternative to HSG to determine proper placement.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

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.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

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.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

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.

Does the story establish the true novelty of the approach?

Satisfactory

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?).

Does the story appear to rely solely or largely on a news release?

Not Satisfactory

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.

Total Score: 3 of 10 Satisfactory

Comments (1)

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Amanda

July 9, 2015 at 11:35 pm

Any type of confirmation test to confirm placement of Essure is pointless anyway. It gives women a false sense of security when they are told the inserts are in place and their tubes are occluded. Not only that, but no matter which method you use to confirm placement, it’s very difficult to assess the exact location of the inserts anyway. The smallest perforation could occur, go completely undetected, and cause tremendous pain. We’ve seen it happen time and time again on the Essure Problems forum with both HSG and Ultrasound. We’ve also learned from a reliable source that occlusion isn’t important or even expected for Essure to be effective. The materials work kind of like an IUD as in it prevents sperm from transporting through the fallopian tubes. There is no evidence that Essure is actually mechanically closing the tubes. So, in my opinion, announcing that TV Ultrasound has been approved as an alternative confirmation test is nothing more than a desperate attempt by the manufacturer to get anything other than negative press out in headlines. Either that or they realized that the original manufacture themselves mentioned years ago in a filing with the SEC that the HSG test is extremely painful and inaccurate! THAT’S why there’s no depth to the announcement!

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