Health News Review

Story gave an incomplete picture of harms, complications and followup required with the device. Didn’t adequately compare cost or effectiveness with other methods.

Our Review Summary

Essure is a permanent sterilization system that has been available in the US since 2002. Placement does require a procedure and sedation. It typically lasts about 30 minutes and is called hysteroscopy. To accomplish placement the cervix is dilated and a hysteroscope inserted into the uterus to see the fallopian tube openings and to place the coils. Essure is a highly effective birth control method, however it is significantly more expensive than other long-term birth control methods such as the IUD or vasectomy.

This story adequately represents the availability and novelty of Essure. It quotes multiple sources that provide very valuable perspectives for the reader. The story does a good job describing side effects around the time of placement but fails to note risks of complication and harms from the procedure, rates of failure of the procedure, or risk of complications from the radiology study required at 3 months after placement that injects dye into the uterus and uses x-ray imaging to assure the tubes are blocked.

The story could have been improved by not merely mentioning the insurance coverage of Essure but also describing the actual costs, which are higher than other methods. Finally, the story does not adequately describe the strength of the evidence to support Essure. It mentions that Essure is 99.8% effective according to company studies. How does this level of effectiveness compare to other methods discussed in the article? Does that mean that no studies have been done that are not company-sponsored? How reliable are the results of those studies?  One ob-gyn said IUDs were "safer and cheaper" but how much safer and cheaper?


Criteria

Not Satisfactory

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The story mentions "Insurance typically pays for the full cost when performed in the hospital, except co-pays and deductibles."  But we are never given the actual cost of the device itself. Estimates of the cost of the device vary from $1300 to $3500, and a hysterosalpinogram is required at 12 weeks to check for tissue growth and tubal blockage, which also adds to the cost. By comparison, an IUD costs less than $500.

Not Satisfactory

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

Not Satisfactory

The story correctly represents the effectiveness of Essure. The story should have compared Essure to other long-term birth control methods such as the IUD and vasectomy. For women for whom the procedure works it has the same effectiveness as the progesterone containing IUD (0.2% per year) and not quite as "perfect" as male sterilization (which is also the most cost-effective method) with a failure rate of 0.15% in the first year and 0.1% thereafter.  Male sterilization is even more effective when combined with repeated late semen analysis (similar to the HSG used to confirm Essure has "worked").

 

Not Satisfactory

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

Not Satisfactory

The story provides some information on the harms of the procedure, however it understates the risk of hysteroscopy by calling it a "non-invasive" and "non-surgical method." Hysteroscopy is associated with risk of uterine perforation, infection and bleeding.

Not Satisfactory

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

Not Satisfactory

The story does not adequately describe the strength of the evidence to support Essure. It mentions that Essure is 99.8% effective according to company studies. Over what time period? After 12 weeks? Does that mean that no studies have been done that are not company-sponsored? How reliable are the results of those studies?

Satisfactory

Does the story commit disease-mongering?

Satisfactory

The story does not engage in disease mongering.

Satisfactory

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

Satisfactory

The story quotes multiple sources who provide very valuable perspectives for the reader.

Satisfactory

Does the story compare the new approach with existing alternatives?

Satisfactory

The story mentions other long-term birth control methods such as vasectomy and the IUD. But it missed the opportunity to compare effectiveness with other methods. (See "Quantification of Benefits of Treatment" criterion above.)

Satisfactory

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

Satisfactory

The story explains that "Some 290,000 women worldwide have undergone the Essure procedure since 2002, according to the company." But it does not discuss how many physicians are trained in implanting the device.

Satisfactory

Does the story establish the true novelty of the approach?

Satisfactory

Clearly Essure is not a new idea. The story clearly states that it has been on the market since 2002.

Not Applicable

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

Not Applicable

Because the story quotes multiple sources the reader can assume the story did not rely on a press release as the sole source of information.

Total Score: 5 of 9 Satisfactory


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