Complications reported include hernia recurrence, removal surgery, infections, wound problems, and abdominal pain This high rate of failure led Ethicon to remove the product from the market. In a May 2016 announcement, the removal of Ethicon’s Physiomesh Flexible Composite mesh was categorized as a “Market Withdrawal” and not a hernia mesh recall. Ethicon failed to clearly define the factors behind the high mesh failure rate. Ethicon said that the failure rate could be due to a several factors: hernia mesh design, the physician’s instructions, and patient selection. In October 2012, the FDA sent a warning letter to Atrium for their failure to address C-Qur mesh infection and sterility complaints. Thirty-five complaints were made after finding human hair in the device. In July 2013, Atrium issued a Class 2 FDA recall of C-Qur mesh because the coating could stick to the package lining if exposed to high levels of humidity. This separation could increase the risk of infection. The FDA filed a lawsuit against Atrium for poor quality control at their New Hampshire manufacturing facility, forcing the company to stop production and distribution of the C-Qur mesh.