Ethicon

History

2023: Johnson & Johnson pleads guilty to patient deaths from her defective hernia nets

On December 1, 2023, Johnson & Johnson announced the settlement of more than 200 lawsuits related to the supply of rejected hernia nets to the market. We are talking about Physiomesh products manufactured by Ethicon, a subsidiary of Johnson & Johnson. Read more here.

2019

Johnson & Johnson to pay $117 million to sell defective vaginal nets

On October 17, 2019, Johnson & Johnson agreed to pay $117 million to settle the trial, the initiators of which accused the company of unfair advertising of vaginal mesh implants. Read more here.

Johnson & Johnson recalls defective surgical crosslinkers that cripple

In late March 2019, Johnson & Johnson began recalling defective surgical crosslinkers that could potentially lead to various side effects, including lethal ones. On May 30, 2019, U.S. regulators scheduled a public advisory committee meeting to review all Johnson & Johnson Surgical Stitcher Reports in an expert, comprehensive manner and issue a final verdict.

During the investigation of complaints and product returns, Ethicon, a subsidiary of Johnson & Johnson, confirmed the existence of a defect of intraluminal surgical crosslinkers, which are used in gastrointestinal operations to create connections between structures (anastomoses).

The company confirmed that in two patients, the use of a defective crosslinker led to the development of severe adverse events. Crosslinker failure caused additional resection (mid rectum in one patient and lower rectum in another patient) during elective resection of the upper rectum.

FDA warned of risks of developing serious complications up to death with surgical staplers manufactured by Ethicon, part of the Johnson & Johnson group

Based on the results of a one-year investigation, the regulatory authorities concluded that the use of a defective device could lead to serious injury or death of the patient, and initiated an immediate recall of the devices from the market. Potential risks to patients include death, sepsis, bleeding, application of permanent stoma, lifelong nutritional and digestive problems, anastomosis divergence, the need for additional surgeries to create new anastomoses, the high need for antibiotics, and the need for additional imaging studies, including radiographic.

As a result, the regulatory authorities took measures to tighten the requirements for intraluminal stitchers, presented new labeling recommendations for surgical staplers and staples, and appointed a meeting of the public advisory committee.^[1]

Buying Takeda surgical patch business for $400m

In May 2019, Takeda Pharmaceutical announced the sale of the TachoSil fibrin glue-based patch business to Ethicon. The transaction value is $400 million. Read more here.

Marriage in stitching machines that injure the stomach and cause hemorrhage

In late March 2019, Johnson & Johnson issued a notice regarding defective intraluminal crosslinkers manufactured by an Ethicon subsidiary. This equipment does not guarantee the integrity of malformed staples and uncut washers that can injure the stomach and cause hemorrhage. The notice was sent to all Johnson & Johnson customers in Europe, the Middle East and Africa (EMEA).

Johnson & Johnson identified the marriage in an investigation into several complaints. The company said it has already taken corrective action to ensure the safety of the medical device. These actions covered 378 batches of intraluminal crosslinking devices, which went on sale to the markets of several countries.

Ethicon Intraluminal Crosslinking Machine

The company said in a release that if the brace problem is not properly resolved or recognized in time, there is a potential risk of postoperative anastomosis divergence, gastrointestinal injury, hemorrhage or hemorrhagic shock. Ethicon reported that it has already received several reports of adverse events due to malformed staples, but the frequency of such events does not yet exceed 0.1%.

The company provided recommendations to customers, advised them to use undiscovered devices if possible, and asked them to return the deliberately defective devices. In the absence of alternatives, Ethicon recommends that surgeons adhere to a specific action plan to avoid possible problems with the device. Surgeons should ensure that the thickness of the tissue to be sewn is within the specified range, and the trigger acts properly to ensure that the staples are formed properly and the tissue is sewn together.^[2]

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