Covidien LLC recalls Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Usage: The PCOPM15 and PCOPM20 reorder co…

Recall date

October 5, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0461-2019

FDA classification

Class II

Brand / firm

Covidien LLC

Sold / distributed

Worldwide distribution--US Nationwide

Why it was recalled

The firm is issuing this voluntary removal following receipt of reports of parastomal mesh failure identified several years following parastomal hernia repair using the modified Sugarbaker repair technique. In these reports, product failure led to hernia recurrence requiring additional surgical treatment. Symptoms of hernia recurrence may include discomfort, localized pain-free or painful bulging, and possible changes in the overlying skin. Medtronic has received, worldwide, a total of ten reports of mesh failure following use of the product in the last five years. Patients who have received a Parietex" composite parastomal mesh for the treatment of a parastomal hernia should continue to receive ongoing monitoring by their healthcare providers for the recurrence of a parastomal hernia.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Usage: The PCOPM15 and PCOPM20 reorder codes are circular in shape, made from a three-dimensional monofilament polyester fabric with a two-dimensional monofilament polyester central band. One side of the design is completely covered with the hydrophilic film. On the opposite side, only the two-dimensional central band is coated with the absorbable hydrophilic film. The film extends 5 mm over the external edge of the reinforcement. The Parietex composite parastomal mesh is indicated for the reinforcement of soft tissues during surgical repair, and specifically for the repair of parastomal hernias. The non-absorbable polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh when in direct contact with the viscera.