Injuries Linked to Ethicon’s Physiomesh [Timeline]

Ethicon Applies for FDA Approval of Physiomesh

March 8, 2010 – Ethicon, Inc. applies for FDA approval of Phsyiomesh Flexible Composite Mesh, used to repair abdominal hernias. Ethicon uses the FDA’s “fast-track” 510(k) approval process, which does not require Ethicon to conduct clinical safety and efficacy trials. Source

FDA Approves Physiomesh to Use for Hernia Repairs

April 9, 2010 – FDA approves Ethicon’s Physiomesh Flexible Composite Mesh to use in surgical repair of hernias and other conditions that require mesh reinforcement. Source

FDA Notified of Physiomesh Infection Case

November 30, 2011 – The FDA receives a report linking Ethicon’s Physiomesh to infection and reoperation. Source

Ethicon Applies for FDA Approval of Second Physiomesh

September 17, 2014 – Ethicon, Inc. applies for FDA approval of Physiomesh OPEN Flexible Composite Mesh through the FDA’s “fast-track” 510(k) approval process. Source

FDA Warns of Serious Hernia Mesh Side Effects

October 6, 2014 – The FDA releases a safety communication warning doctors and patients of serious side effects associated with hernia mesh, including pain, adhesions, and hernia recurrence. Source

FDA Approves Physiomesh OPEN for Use in Open Hernia Repairs

October 23, 2014 – The FDA approves Ethicon’s Physiomesh OPEN Flexible Composite Mesh for use in open ventral hernia repair. Source

Physiomesh Linked to Higher Rates of Recurrence and Reoperation

2016 – A large data analysis from two independent health data registries links Physiomesh with a higher rate of recurrence and reoperation than comparative products. Source

Illinois Man Files Ethicon Physiomesh Lawsuit

April 1, 2016 – An Illinois plaintiff files a lawsuit against Ethicon, claiming Physiomesh caused him to suffer serious injuries requiring additional surgery and resulting in ongoing health problems. Source

Ethicon Removes Physiomesh Flexible Composite Mesh from the Market

May 25, 2016 – Ethicon and parent company Johnson & Johnson send an urgent field safety notice to hospitals and medical centers warning them to stop using Physiomesh for laparoscopic repairs, after the product was found to have higher rates of recurrence and reoperation compared to other similar products. Physiomesh is removed from the market. Source

Plaintiff Files Physiomesh Lawsuit Over Recurrence; Claims Manufacturers Were Aware of the Dangers

December 2016 – A Florida plaintiff seeks punitive damages against Ethicon, claiming Physiomesh caused her recurrent hernia, pain, and adhesions, and alleging that the manufacturers continued to sell the product well after they were aware of its safety risks. Source

Georgia Woman Blames Manufacturers for Physiomesh Intestinal Obstruction

February 2017 – A Georgia woman files a federal lawsuit claiming Physiomesh caused hernia recurrence and intestinal obstruction. Source