Ethicon: Devices, Recalls & Lawsuits

Ethicon is a well-known and respected manufacturer of medical devices such as surgical staples, sutures and mesh products, owned by Johnson & Johnson. It is a major hernia and transvaginal mesh product manufacturer and has made significant medical technology contributions.

Johnson & Johnson purchased G.F. Merson Limited in 1947, renaming it Ethicon Suture Laboratories in 1949, and eventually Ethicon Inc. in 1953. It has grown over the past several decades by acquiring existing medical device companies: Mentor in 2009, NeuWave in 2016, Megadyne in 2017 and TachoSil in 2019.

These acquisitions allow Ethicon to remain competitive in a broad portion of the medical device market. According to its 2023 annual report, Johnson & Johnson had 2023 annual sales of over $85 billion, of which more than $30 billion was in the medical technology space. Ethicon’s peak revenue in 2023 was $4.9 billion.

Doctors use transvaginal mesh to support weakened muscles in the pelvic floor. It can help correct organ prolapse and urinary incontinence. Ethicon currently manufactures three types of transvaginal mesh: GYNECARE GYNEMESH, GYNEMESH INTERCEDE and ARTISYN Y-Shaped Mesh.

Gynecare Gynemesh mesh products are nonabsorbable polypropylene mesh patches designed to correct vaginal prolapse. Surgeons use them in laparoscopic procedures.

Gynemesh Intercede is a gynecological mesh used for several different procedures. It is an absorbable product designed to reduce the risk of adhesions.

Artisyn Y-shaped mesh is a partially absorbable product designed to help correct vaginal vault prolapse. Made from a blend of poliglecaprone 25 and polypropylene, it features a unique shape that reduces folding and wrinkling.

Complications

Transvaginal mesh complications may include pain, bladder and bowel dysfunction and discomfort during sex. Some patients who received Ethicon transvaginal mesh experienced severe complications including infection, mesh erosion and severe chronic pain. Such complications can cause patients significant distress and disrupt their normal activities.

Recalls

The FDA issued a class 2 recall of 160 units of Ethicon’s Prolift pelvic floor repair mesh in April 2007. This was the only major FDA transvaginal mesh recall of Ethicon products. However, the company halted sales of several products, including the Prolift mesh, after facing multiple lawsuits over complications.

Lawsuits & Settlements

Ethicon faced multiple transvaginal mesh lawsuits filed by patients injured after using its products. This resulted in significant financial strain and caused Ethicon to stop sales of its Prolift pelvic floor mesh products.

Ethicon transvaginal mesh lawsuits have led to mixed results. For example, in February 2023, the Supreme Court upheld a verdict against Johnson & Johnson, stating it hid the risks of its mesh products. In March of the same year, a Florida jury ruled in favor of Ethicon, ruling that the Prolift mesh devices were not defective. While most cases have been resolved, lawyers continue to file new ones.

Ethicon medical devices include several types of hernia mesh products. Surgeons insert hernia mesh over tears to repair the hernia and stabilize surrounding tissue. The use of mesh decreases the incidence of hernia recurrence after surgery. Popular Ethicon hernia mesh products include Physiomesh, PROCEEDTM and PROLENETM surgical mesh products.

Physiomesh is a skirted mesh patch used in open ventral hernia repairs. It features a flexible composite material and a hexagon shape that helps with adhesion. Physiomesh is partially absorbable.

PROCEEDTM is a strong mesh product used for intraperitoneal onlay mesh repair procedures. It provides a secure bond and breathable, microfilament composition. Special properties reduce the risk of adhesion to surrounding tissue and organs, which increases patient comfort during healing.

The PROLENETM line from Ethicon medical devices includes several polypropylene mesh products. The PROLENETM hernia repair system, 3D patch, soft mesh and standard mesh are non-absorbable and suitable for a range of hernia repair procedures.

Complications

Hernia mesh complications include adhesion to surrounding tissue, infection, pain, mesh migration, stretching and failure. Many patients report pain and discomfort associated with mesh. This can result from the mesh patch adhering to and stretching neighboring tissue. It may also be from the surgical procedure itself.
Infection is a risk for any surgery, including hernia repair. Nonsterile products increase the risk of infection and can endanger patient lives.

Mesh failure is a complication unique to this type of procedure. In some cases, the mesh patch used stretches, resulting in a recurring hernia. It can also fail, causing a recurrence and serious injury.

Complications can occur with any brand of mesh, but defective products may increase risks. Ethicon faced difficulties with multiple lots of hernia mesh products, resulting in product recalls and possible injury to patients.

Recalls

Ethicon hernia mesh issues led to a recall of its popular Physiomesh Flexible Composite Hernia Mesh in 2016. At that time, the company issued a voluntary worldwide market withdrawal of Physiomesh products based on possible safety risks highlighted in two large, unpublished studies.

The company chose to issue a withdrawal of all unused stock. This affected products in Australia, Europe and the United States.

Between 2006 and 2020, Ethicon issued multiple recalls for its PROCEEDTM hernia mesh patches that covered more than 18,000 devices. The FDA classified all PROCEEDTM recalls as class 2 medical device recalls.

PROCEEDTM Ethicon device recalls cited possible delamination of mesh layers designed to prevent adhesion. Devices that lose their coating have a greater risk of causing adhesions and bowel complications.

Lawsuits & Settlements

The court system combined numerous Ethicon lawsuits over its Physiomesh products into a multidistrict litigation case in Georgia. The court dismissed the remaining hernia mesh lawsuits in this litigation in 2023 after both sides agreed to a settlement. The company also faces multicounty litigation in New Jersey for the same product. Plaintiffs continue to file new cases.

Additionally, Ethicon faces multiple lawsuits over its PROCEEDTM and PROLENETM mesh products. Overall, Ethicon has paid millions of dollars to plaintiffs for injuries caused by hernia mesh products.

Surgical staplers compress two pieces of skin and attach them using specially designed staples. Doctors use them instead of sutures for increased patient comfort. Ethicon manufactures the Echelon, Endopath, Ethicon and Proximate staplers.

Complications

Complications from surgical staplers include pain, excessive bleeding and infection. When a surgical stapler malfunctions, it can cause severe surgical complications, including tissue damage, sepsis and death. Ethicon faced numerous complaints of faulty Endo-Surgery devices causing complications.

Recalls

The FDA issued a Class 1 recall of multiple Ethicon Endo-Surgery staplers in 2019. This is the most severe class of recall, indicating immediate patient danger. Affected models included all sizes of the Curved and Straight Intraluminal Staplers. According to recall data, the company warned that the staplers may lack sufficient power to form staples correctly.

Class 2 recalls affected the Proximate stapler in the same year. This recall stated that the Ethicon medical devices in question may not have a required washer, resulting in tissue damage and bleeding.

Lawsuits & Settlements

Patients affected by faulty staplers filed numerous surgical stapler lawsuits. Ethicon largely maintains that surgical error is to blame for injuries resulting from its staplers. However, some patients have received significant awards. For example, in 2021, a Miami court awarded a patient $10.3 million in damages. Anyone injured from an Ethicon surgical stapler may consider a consultation with an attorney.