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SURGICAL STAPLER RECALLED BY FDA

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SURGICAL STAPLER RECALLED BY FDA

Johnson and Johnson is facing another medical device recall, this time with surgical stapler devices used in the treatment of hemorrhoids.  More than 150,000 of these devices are being taken off the market by the FDA in a Class 1 recall, which is the most serious type.

The following devices are subject to the recall:

  • Ethicon Proximate HCS Hemorrhoidal Circular Stapler and Accessories 33m
  • Ethicon Proximate PPH Circular Stapler and Accessories 33m
  • Ethicon Transtar Circular Stapler Procedure Set

These devices are used in procedures to treat hemorrhoids.  The problem stems from incomplete staple formation when trying to fire the stapler, resulting in the following serious side effects:

  • Severe pain
  • Sphincter dysfunction
  • Rectal wall damage
  • Sepsis (a serious medical condition caused by an overwhelming immune response to infection)
  • Bleeding
  • Occlusion of the rectal canal
  • Splitting of the rectal wall staple line and bleeding

Medical device recalls and litigation are not new to Johnson and Johnson.  The company has recalled several products recently, and was the subject of the DePuy metal hip implant recall and litigation.

If you or a loved one have been injured by any of these surgical stapler devices, contant us today to discuss your options.

Go to the FDA website for more specifics regarding the recall:

http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm325570.htm

Other sources:

http://online.wsj.com/article/SB10001424052970204098704578080853291021898.html

http://www.trefis.com/stock/jnj/articles/151546/jnjs-medical-devices-business-faces-another-recall-with-stapler/2012-10-30