ethicon Archives - Medical Design Sourcing

Johnson & Johnson MedTech expands Ethicon operations in Puerto Rico

Manatí, Puerto Rico [Image courtesy of Google]Johnson & Johnson MedTech (NYSE: JNJ) + announced plans to expand an existing manufacturing facility in Puerto Rico to support Ethicon products.

According to a company spokesperson, the expansion plans in Manatí, Puerto Rico, aim to increase production capacity for key Ethicon products. The company expects to add an estimated 100,000 square feet of manufacturing capacity.

Customer demand has led to a need for supply chain expansion, according to J&J MedTech and Ethicon. The company feels refurbishing the Manatí site enables the shifting of key Ethicon manufacturing at its San Lorenzo facility to the new site to continue meeting demand.

According to The San Juan Daily Star, Puerto Rico Gov. Pedro Pierluisi Urrutia and Economic Development and Commerce (DDEC by its Spanish acronym) Secretary Manuel Cidre Miranda participated in Johnson & Johnson’s announ…

10 surgical robotics companies you need to know

The surgical robotics space saw a major shakeup last year. The da Vinci SP surgical robotics system [Image courtesy of Intuitive Surgical]“Robotics is hard. Robotics in healthcare is hard.”

Hani Abouhalka, Johnson & Johnson’s company group chair for Robotics & Digital, said those words at our DeviceTalks West event in California in October.

It pretty much sums up the situation for medtech companies large and small that sought to compete against Intuitive in the soft-tissue surgical robotics space. Despite the increased competition, Intuitive remains the undisputed leader. It’s even moving forward on a next-gen da Vinci robot.

For its part, Johnson & Johnson is sticking with plans to develop its Ottava surgical robot. J&J now plans to submit Ottava for FDA investigational device exemption (IDE) in the second half of 2024 in order to start clinical trials.

Even though it is sticking with robotic surgery, J&J laid off employees in th…

Megadyne Medical recall of patient return electrodes is Class I

The Mega Soft Universal patient return electrode. [Image from Megadyne Medical]The FDA deemed a recall of some Megadyne Medical patient return electrodes, manufactured by J&J’s Ethicon, as Class I, the most serious kind.

This action is a correction, not a product removal.

Megadyne recalled its Mega Soft Universal, Universal Dual, Universal Plus and Universal Plus Dual patient return electrodes. It initiated the recall on Dec. 8, with the action affecting 9,428 devices distributed between Oct. 1, 2021, and Dec. 4, 2023.

The company initiated this recall to update the instructions for use and product labeling. It seeks to restrict device use to patients 12 years and older. Megadyne received reports of patient burn injuries, including third-degree burns requiring intervention. Burn injuries could lead to extended hospital stays, scarring and additional surgeries.

Severe burns could lead to potentially long-lasting impacts on patients, especial…

Integra LifeSciences to buy Johnson & Johnson’s Acclarent and its ENT tech

Integra LifeSciences (Nasdaq: IART) + announced today that it entered into a definitive agreement to acquire Acclarent from Johnson & Johnson MedTech.

Acclarent, part of J&J MedTech’s Ethicon unit, enhances Integra’s position in the ear, nose and throat (ENT) treatment market. Integra already offers the MicroFrance line of ENT instruments. The company believes that, upon closing, the deal propels it into a position as a leading provider of ENT products and technologies.

Integra agreed to acquire Acclarent for $275 million in cash at closing. The deal also includes an additional $5 million upon the achievement of regulatory milestones.

“This acquisition presents Integra with a rare opportunity to become a key player in the ENT segment. Acclarent’s culture of pioneering technologies aligns with Integra’s legacy of innovation to transform care and restore patients’ lives,” said Jan De Witte, pre…

Johnson & Johnson’s Ethicon settles more Physiomesh suits

Johnson & Johnson has settled more than 200 cases remaining in a multi-district litigation over hernia mesh made by its Ethicon subsidiary.

U.S. District Court Judge Richard Story in Northern Georgia on Dec. 1 agreed to dismiss the cases with prejudice at the request of lawyers for both sides. The lawyers had informed him that they had compromised and settled all claims between them, including all counterclaims, cross-claims and third-party claims.

There were no additional details about the settlement in the court documents.

In a statement shared by a spokesperson, Ethicon said:

“While we empathize with any patients who experience medical complications from surgery, our company acted appropriately and responsibly in the research, development and marketing of its hernia mesh products which have been used to care for millions of patients around the world for more than 50 years. This settlement is not an admission of liability or wrongdoing…

Ethicon unveils hemostatic sealing patch in Europe

Johnson & Johnson MedTech’s (NYSE: JNJ) + Ethicon today announced the European approval and introduction of Ethizia, its hemostatic sealing patch.

The adjunctive hemostat solution helps to achieve sustained hemostasis in difficult to control bleeding situations. Ethizia features unique synthetic polymer technology for maximum adaptability. Ethicon said it’s the first and only hemostatic matrix designed to be equally active and efficacious on both sides.

Ethizia offers easy handling in both open and minimally invasive surgery. It’s capable of being stuffed, rolled, pulled apart, trimmed and tailored, Ethicon said in a news release. In 80% of clinical trial patients studied, the patch stopped bleeding in 30 seconds. That averages out to six times faster than the leading fibrin sealant patch, Ethicon said.

The patch received CE mark approval as an adjunctive hemostate for disruptive bleeding on inte…

J&J’s Ethicon unveils AI-powered laparoscopic training tech

Johnson & Johnson MedTech’s (NYSE: JNJ) + Ethicon unit today debuted an AI-powered laparoscopic surgical simulation platform.

The first-of-its-kind device integrates augmented reality, AI-guided assessment and tactile feedback. It aims to enhance the surgical skills and training experiences for general, gynecological and laparoscopic surgeons.

Ethicon debuted the system at the American Association of Gynecological Laparoscopists (AAGL) Global Congress. The company said in a news release that its technology “ushers in a new era in surgical training.” The Ethicon Laparoscopic Skills Training Platform offers a highly portable connected digital learning experience. It features adaptability to the learner’s evolving circumstances and integrates into everyday quality education and training routines.

The platform offers personalized and innovative education to expand reach and deepen knowled…

These devices are the top targets of lawsuit-related advertisements

Surgical mesh products continue to drive medical device lawsuit spending. [Photo via Adobe Stock]

Spending on advertisements related to medical device lawsuits this year is on track to exceed last year’s tally.

That’s according to figures provided by Washington, D.C.-based X Ante, which uses data from ad intelligence firm Vivvix. X Ante supplies reports on medical device lawsuit ad spending to the Advanced Medical Technology Association (AdvaMed), which is calling for new federal regulations of mass tort advertising to protect device manufacturers from lawsuits bankrolled by third-party funders.

For the first half of 2023, $6.2 million worth of legal ads targeted five kinds of medical devices:

Pelvic mesh: $3.5 million Hernia mesh: $1.9 million CPAP machines: $532,000 Physiomesh: $262,000 Military earplugs: $54,000

Spending on the top five device categories totaled just under $11 mil…

AdvaMed takes aim at device lawsuits funded by third parties

The Advanced Medical Technology Association (AdvaMed) is asking for new regulations to protect device manufacturers from lawsuits bankrolled by third-party funders.

Ahead of a U.S. House Committee on Oversight and Accountability hearing on the topic tomorrow, AdvaMed General Counsel and Chief Policy Officer Chris White submitted a letter in which he said “most mass tort litigation against medical device manufacturers is fueled by banks, private equity firms and hedge funds.”

AdvaMed wants new federal regulations of mass tort advertising like laws passed in Tennessee and Texas.

“The influx of billions of dollars of third-party litigation funding has fundamentally changed the dynamics of mass tort litigation,” White wrote. “These financiers are injecting huge amounts of investment capital into creating litigation regardless of the merits,” White wrote in the letter. “They start by funding mass marketing campaigns on TV, radio,…

J&J’s Ethicon has a serious Megadyne electrode recall due to potential burns in electrosurgery

The Megadyne Mega Soft and Mega 2000 electrodes manufactured by J&J’s Ethicon. [Images from the FDA]The FDA labeled a recall of Megadyne electrode products manufactured by Johnson & Johnson’s Ethicon Class I, the most serious kind.

Recalled products include a number of Megadyne Mega Soft electrodes and the Mega 2000 patient return electrode. Ethicon paid an undisclosed amount to acquire Megadyne Medical Products in 2017 after several years of collaboration.

According to an FDA notice, the recall affects 21,200 devices in the U.S. The firm distributed those devices between March 11, 2021, and May 9, 2023, before initiating the recall on June 1, 2023.

Both the Mega 2000 and Mega Soft reusable patient return electrodes are soft pads used during electrosurgery. During these procedures, an electric current heats or cuts tissue or stops bleeding. An electrosurgical generator creates the electric current and a small, pen-like attachment deliver…

Supreme Court denies J&J appeal of $302M vaginal mesh ruling

The U.S. Supreme Court today declined to hear Johnson & Johnson‘s (NYSE:JNJ) appeal of a $302 million judgment for false and deceptive marketing of its vaginal mesh implants.

The nation’s highest court denied the medtech maker’s bid for review without comment, allowing the California ruling to stand.

Attorneys for the state sued Johnson & Johnson and its Ethicon subsidiary in 2016, alleging the company neglected to tell patients and physicians about potentially severe complications and misrepresented the frequency and severity of the risk.

The case went to trial in front of a San Diego County judge in 2019 and resulted in a $343.99 million judgment against the companies in early 2020. The Fourth District Court of Appeals in California cut the civil penalties by $42 million last year.

J&J wanted a review of the case, saying it wasn’t fairly notified of the penalties and that attorneys for the state of California didn&#…

J&J’s Ethicon completes first robot-assisted kidney stone removal with Monarch platform

The Monarch platform for robot-assisted urology procedures. [Image courtesy of Johnson & Johnson’s Ethicon]Ethicon, a Johnson & Johnson MedTech company, today announced the first robotic-assisted removal of kidney stones using the Monarch platform.

Auris Health, an Ethicon subsidiary, received FDA clearance for Monarch for endourological procedures in May 2022. The University of California, Irvine’s UCI Health used the Monarch platform for urology to complete the first procedure.

According to a news release, it’s the first successful robotically assisted, electromagnetic-guided percutaneous access and mini-percutaneous nephrolithotomy procedure. Ethicon said its study involves a collaboration with co-investigator Dr. Mihir Desai from the University of Southern California.

“This clinical study is the first in the world to research and demonstrate the potential for improved navigation, access, clearance and control in mini-PCNL proce…