Prolene Hernia System: Ethicon Inguinal Hernia Mesh

Prolene Hernia System Logo

The Prolene Hernia System (PHS) is manufactured by Ethicon, a subsidiary of Johnson & Johnson.

510(k) Clearance of the Prolene Hernia System

Ethicon received FDA 510(k) clearance for the Prolene Hernia System on September 10, 1997. The initial intended use of the Prolene Hernia System, as stated in the 510(k) application, was for the repair of inguinal hernia defects. However, the instructions for use (IFU) for the Prolene Hernia System currently states that it can be utilized to repair both inguinal and abdominal wall hernia defects. The Hollis Law Firm has observed many patients who have been implanted with a Prolene Hernia System in the abdomen and suffered severe complications as a result.

 

 

 

The Prolene Hernia System is designed similar to hernia mesh plugs, such as the Perfix plug. Severe complications have been associated with the Prolene Hernia System, including sexual dysfunction, removal of a testicle, and severe debilitating pain. More information on the Prolene Hernia System coming soon!

Side view of an unopened Prolene Hernia System (PHS)

 

 

PHS

Occupies Two CompartmentsDeformation of PHSFailing Prolene Hernia System

 

 

 

 

 

 

 

PHS PlugPHS Plug n Patch

 

 

 

 

 

 

 

 

 

 

 

Content Created By:

C. Brett Vaughn RN, BSN, JD