NOTE TO READERS: When this project lost substantial funding at the end of 2018, I lost the ability to continue publishing criteria-driven news story reviews and PR news release reviews - once the bread-and-butter of the site going back to 2006. The 3,200 archived reviews, while still educational, are getting old and difficult for me to technically maintain on the back end of the website. So I am announcing that I plan to remove these reviews from the site by April 1, 2021. The blog and the toolkit - two of the most popular features on the site - will remain. If you wish to peruse the reviews before they disappear, please do so by the end of March 2021. After that date you may still be able to access them via the Internet Archive Wayback Machine - https://archive.org/web/.
Read Original Story

Silicone Breast Implants: Safe, With Caveats

Rating

3 Star

Categories

Silicone Breast Implants: Safe, With Caveats

Our Review Summary

400,000 women have breast implants each year and use is rising. This story was about where we are today with silicone. The use is on the rise but have we really settled the question about safety? The article kind of skirts the scary issues like the autoimmune disease and focuses on the common complications (which are much higher than perhaps people recognized). The story missed a chance to dig into the data and to help women really understand the issue more deeply. Instead, we hear a lot from one plastic surgeon who presents his own point of view.

We would have liked more data, less opinion.

 

Why This Matters

The safety of silicone breast implants is an emotionally charged issue, whether for reconstruction or augmentation; specific facts and clear options help women make better decisions about such a significant surgery.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The article sidesteps any issues related to costs of breast implants or the remedies for failures, a glaring omission in light of frequent complications and adverse outcomes.

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

Not Applicable

Not applicable.  This was about safety.  No good way to quantify benefits.

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

Not Satisfactory

The story discussed common problems, but was silent on:

  •       details on the rare autoimmune disease 
  •      More specific statistics, such as “40 to 70 percent of reconstruction patients requiring  reoperations during the first 8 to 10 years after they received their implants” 

Half the story on harms just isn’t good enough in this case.

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

Not Satisfactory

Missing is reference to the actual FDA- published information on post-approval studies describing:

  •         low follow-up rates,
  •         study limitations,
  •        a higher frequency of Anaplastic Large Cell Lymphoma (ALCL).

Conflicting implications of silicone leakage are anecdotal, rather than evidence-based.

Does the story commit disease-mongering?

Satisfactory

It would be difficult to oversell the caveats in this story; the article presented dramatic, significant concerns.

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

Satisfactory

Two independent experts were quoted.  (Sidney Wolfe’s name was misspelled.) However, the article could have benefited from:

  •             quoting more than one practicing physician (Why was plastic surgeon Schulman chosen?)
  •             indicating whether there was conflict of interest.
  •             linking to the FDA article, for consumer access.
But the story meets the minimum standard for this criterion.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

Saline implants were mentioned briefly but not discussed in any detail. No other options, such as choosing to avoid the procedure with its risks,  or fat relocation, were discussed.

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

Satisfactory

Beginning with a clear description of silicone breast implants…banned in 1992, back five years ago with a concurrent FDA evaluation process…the article does an excellent job of establishing availability.

Does the story establish the true novelty of the approach?

Satisfactory

One focus of the story was the June FDA report – the new angle.

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

Satisfactory

It’s clear that the story didn’t rely solely on a news release.

Total Score: 5 of 9 Satisfactory

Comments

Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.