Johnson & Johnson MedTech Globally Discontinues and Recalls MEGA SOFT Electrosurgical Line Amid Severe Burn Risks

Source: Medical Device Business Review

Author: Commenter

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Recently, due to the risk of severe burns, Johnson & Johnson Medical’s Surgical Division announcedCease ProductionIts electrosurgical device MEGA SOFT, and the product was withdrawn from the global market.Off the shelf。

Source: Ethicon China Official Website

The product names and codes involved in the incident are as follows:

It is reported that MEGA SOFTMainly designed for patients under 12 years old and weighing between 0.8 to 50 pounds (50 pounds = 22.67 kilograms), aiming to address the issues of smaller body size and fragile skin in pediatric electrosurgical procedures.

The product was officially launched in 2009 and has been on the market for 15 years.

"At the initial launch, the Vice President of Marketing for Megadyne at Johnson & Johnson Surgical was quite proud to state, 'This product...'Fills a long-standing gap in the field of pediatric surgery.，”

"Even the youngest surgical patients can benefit from our provenSafe and EffectiveThe return electrode technology and its protection against the risk of skin rupture and pressure sores."

However, it is somewhat ironic that this product, which was marketed for its "safety," was ultimately withdrawn from the market due to "safety concerns."

According to official documents, there have been four injury reports related to this product from 2018 to present.

In July last year, the FDA reported that this product had caused63 people burned,The burn severity was close to third-degree, and the 21,000 products involved were classified as the most serious Level 1 recall.

*The international standard for burn classification is the three-degree, four-division method, namely first-degree burns, superficial second-degree burns, deep second-degree burns, and third-degree burns. First-degree burns are less severe, while third-degree burns are more severe.

As a high-frequency current surgical system applied in operating rooms, electrosurgery integrates various high-frequency current surgical devices and uses computers to control the cutting depth and coagulation speed during surgery to achieve hemostasis and coagulation effects.

Common electrosurgical devices include monopolar electrocautery, bipolar coagulation, ultrasonic scalpel, and return electrode pads, etc.,The electrode products that Johnson & Johnson pulled off the shelves this time are also among them.

With the development of medical technology and the increasing clinical demand, electrosurgical devices have become increasingly indispensable in clinical operating rooms.

According to the research by BIS Consulting, the global electrosurgical devices market size reached 18.619 billion yuan (RMB) in 2022. It is predicted that by 2028, the global electrosurgical devices market size will reachRMB 22.779 billionDuring the forecast period, the global electrosurgical devices market is estimated to have a compound annual growth rate of 3.43%.

However, Johnson & Johnson is not the only company targeting this billion-dollar track.

As early as the beginning of 2015,MedtronicOfficially Announced Investment$50 billionCompletion of the acquisition of Coviden, which is one of the earliest electrosurgical suppliers globally.

After taking the lead, Covidien has also brought considerable returns to Medtronic. To this day, the market share of Covidien's electrosurgical products in Chinese hospitals remains unrivaled.

Besides Medtronic, the German veteran companyErbe、SutterAs a pioneer in the electrosurgical products field, Sutter is the world's earliest manufacturer to develop electrosurgical forceps that never stick.

Not only foreign giants, but also domestic manufacturers in China have made breakthroughs in this field in recent years after years of accumulation.

Such as those established in 1990Shanghai Hutong ElectronicsAnd founded in 1992Changzhou Yanling Electronics,NowadaysHave performed well in both the mid-range and low-end markets.。

In terms of volume, to this day, surgical business remains the largest business segment of Johnson & Johnson Medical.

However, if we look at the development momentum, the growth of its surgical business has lagged far behind interventional and ophthalmology.

Johnson & Johnson Medical Releases 2023 Financial Report,Surgical ServicesSales reached $10.37 billion, maintaining the largest volume, but the year-on-year growth was only 3.6%, ranking last in terms of increase among the four major businesses.

Thus, in an era where giants are seeking to reduce costs and increase efficiency, the "pruning and trimming" of surgical business operations has also been put on the agenda.

At the end of last year (December 13, 2023),Johnson & Johnson SurgeryAnnounced that it will acquire for $280 million (approximately RMB2 billion) to sell its Acclarent ENT subsidiary to neuroregulation leader Integra LifeSciences.

Acclarent Subsidiary isOne of the largest providers of balloon sinus dilation globally，It is also one of the main business branches of Johnson & Johnson Medical.

In 2010, Johnson & Johnson spent $785 million (approximately RMB5.6 billion) The price will acquire Acclarent,This part of the business had an income of 110 million US dollars (approximately RMB780 million）。

The sell-off with a price difference of up to 3.6 billion undoubtedly constitutes a "fire sale," and Ethicon's "sacrifice" goes far beyond this.

Aside from its less-than-ideal performance, frequent litigation quagmires have been a long-standing nightmare for Ethicon.

Before MEGA SOFT, another Johnson & Johnson product that was withdrawn from the market also originated from the surgical department.

Rewind to February last year, when Johnson & Johnson DePuy Synthes was promoting in a deceptive mannerFemale Pelvic Mesh Implants, inLost the appeal and was ordered to pay compensation$302 million(Approximately RMB2.2 billion）。

According to Drugwatch statistics, in the past decade, the compensation amount claimed by giants for mesh devices has exceeded$8 billion (RMB 55.2 billion), including Johnson & Johnson Ethicon, BD, Boston Scientific, Coloplast, etc.

However, in the "high-risk area" of mesh devices,，Johnson & Johnson's Ethicon is reportedly one of the companies with the slowest settlement offers and the highest number of complaints in all mesh device disputes.

In February 2013, Johnson & Johnson lost its first lawsuit involving transvaginal mesh implants, with a New Jersey jury ruling in favor of injuries caused by Ethicon's Gynecare Prolift.$11 millionThe verdict.

The plaintiff claims to have undergone 18 revision surgeries after receiving the mesh implant and has also had to frequently take painkillers.

Thereafter, until Johnson & Johnson's device exited the U.S. market in 2019, the disputes remained unresolved.

Following the group's business adjustments, there have been significant changes in Johnson & Johnson's senior management, including the departure of the head of Johnson & Johnson's surgical business.

In February this year,Chairman of Johnson & Johnson Medical, Head of Johnson & Johnson Surgical BusinessMr. Vladimir MakatsariaAnnounced officiallyFrom Johnson & Johnson MedicalResignation.

Mr. Makatsaria works in the medical device business of Johnson & Johnson.For up to 30 years,A veteran backbone of Johnson & Johnson's medical division。

Since joining Johnson & Johnson in 1996, he has worked his way up from the grassroots to global regional business.Vice President、President, then byRegional ChairPromoted to Johnson & Johnson Medical GroupChairman、Global Head of Surgical Business Department。

Makatsaria's departure is undoubtedly a significant loss for Johnson & Johnson's surgical division.

Conclusion

In sharp contrast to the series of "strategic tightenings" and "accident-prone" situations in Johnson & Johnson's surgical department is the aggressive expansion of its interventional department.

"Add" and "Subtract" Between,It is not difficult to see that, under the new industry changes, the once glorious Johnson & Johnson's surgical department is actively or passively making some sacrifices and concessions.

And in this major cleanup, "loss-making production lines" and "problematic production lines" will undoubtedly become the preferred targets for this medical device giant to take action on.

On this occasion, MEGA SOFT's exit is not the first case, and probably not the last one either.