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Ethicon, Inc., is a subsidiary of Johnson & Johnson. The company is part of the Johnson & Johnson MedTech business segment. It was incorporated as a separate company under the Johnson & Johnson umbrella in 1949 to expand and diversify the Johnson & Johnson product line.

Key Information

Ethicon has manufactured surgical sutures and wound closure devices since 1887. After World War II, Ethicon's market share in surgical sutures rose from 15% to 70% worldwide.[citation needed] In the United States, the market share is approximately 80%.[citation needed]

Ethicon conducts business in 52 countries.

Corporate history

[edit]

In 1915, George F. Merson opened a facility in Edinburgh for the manufacturing, packaging and sterilising of catgut, silk and nylon sutures. Johnson & Johnson acquired Mr. Merson's company in 1947, and this was renamed Ethicon Suture Laboratories.[4] In 1953 this became Ethicon Inc.[5]

In 1992, Ethicon was restructured, and Ethicon Endo-Surgery became a separate corporate entity.[6]

In 2008, Ethicon sold its wound management business to One Equity Partners and became Systagenix Wound Management Limited.[7]

In 2009, Ethicon acquired breast implant maker Mentor,[8][9] and in 2010 it acquired ear, nose and throat technology company Acclarent.[10] In 2016, Ethicon acquired NeuWave Medical.[11]

In 2013, J&J merged Ethicon Endo-Surgery back into Ethicon.[6]

As of September 10, 2024, Ethicon began operating under the name Johnson & Johnson MedTech.[12]

Physiomesh class action lawsuits

[edit]

On June 13, 2016, Health Canada issued a recall of Ethicon's Physiomesh Flexible Composite Mesh Product used for ventral hernia repair.[13] The product had been on the Canadian market since September 2010 and patients claimed a range of complications following surgery.[14] The proposed Canadian class action, filed June 1, 2017 is seeking court approval for certification as a class action and is expected to proceed in 2019.[15]

Gynecare Prolift controversy

[edit]

There is some controversy around Ethicon's transvaginal meshes used on patients with female genital prolapse.

Ethicon's Gynecare Prolift, was introduced in March 2005, bypassing FDA review. The company felt its basic polypropylene had already been approved and therefore it did not need to reapply for clearance for its Prolift kit. Three years later, when Ethicon tried to obtain clearance for its Prolift +M, the FDA was alerted to the fact that Prolift had been on the market. The agency approved the Prolift and Prolift +M with no penalty. Both were cleared through the Food and Drug Administrations 510(k) clearance process, that is clearance to sell.[16] Ethicon's parent company Johnson & Johnson utilized the FDA's 510(k) clearance method, which allows a product to be sold without official FDA approval if it is based on another already approved product. However, in 2008, the FDA issued a Public Health Notification regarding reports of serious complications associated with transvaginal mesh devices. This escalated in 2011 when the agency received more than 1,000 adverse effect reports from surgical mesh manufacturers. The FDA decided to order Ethicon and other transvaginal mesh manufacturers to cease production until extensive testing and research on each of vaginal mesh device was conducted. In June 2012, following the FDA's order for additional testing, Johnson & Johnson permanently removed all Prolift products from the market.[17]

In one court case reported by Reuters, the plaintiff, Dianne Bellew, who had been implanted with the product in 2009, said she was never warned about how the device could contract and erode, causing pain and scarring.[18]

References

[edit]
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Ethicon

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Ethicon, Inc. is a global company and wholly owned subsidiary of that develops and manufactures surgical technologies, including sutures, staplers, energy devices, and wound closure systems for use in open and minimally invasive procedures. Tracing its origins to the late , Ethicon pioneered the first mass-produced sterilized sutures in the early 20th century and introduced synthetic absorbable sutures like in 1974, alongside advancements in ultrasonic energy tools such as the system and robotic platforms. These innovations have supported surgical practices worldwide for over 130 years, focusing on improving patient outcomes in areas like and metabolic disease management. Ethicon has encountered major controversies through extensive litigation over certain implantable mesh products, including transvaginal mesh for pelvic organ prolapse and the PhysioMesh hernia repair system, which were linked to complications such as infections, erosions, and revision surgeries; this prompted a 2016 global field safety notice and market withdrawal for PhysioMesh, as well as multistate settlements exceeding $100 million each for alleged deceptive marketing practices.

Corporate Profile

Founding and Early Years

Ethicon's origins are rooted in 's early focus on sterile surgical supplies. , founded in , began mass-producing the world's first sterilized surgical sutures in 1887, using materials such as derived from sheep intestines and , which significantly reduced risks in compared to non-sterile alternatives. In 1921, Johnson & Johnson established Johnson Suture Corp. as a dedicated to specialize in suture , emphasizing hand-processed sutures involving soaking, splitting, twisting, and drying techniques. The formal founding of Ethicon occurred in 1949 through the acquisition of G.F. Merson Ltd., a company known for developing eyeless needled sutures that minimized tissue trauma. Johnson & Johnson absorbed Merson's operations and incorporated Ethicon Suture Laboratories on August 11, 1949, as a separate entity under its umbrella to expand and diversify its surgical product line. This structure allowed focused development in wound closure technologies, with the name "Ethicon" derived from "ethical" and "icon," reflecting commitments to quality and innovation in medical ethics. The subsidiary was renamed Ethicon, Inc. in 1953. During its early years, Ethicon prioritized suture production amid post-World War II demand, where wartime needs had boosted output with 90% manual labor by women workers. Key products included and sutures, with research advancing sterilization methods; in 1953, the company acquired a linear accelerator for experimentation, leading to commercial radiation sterilization of sutures starting in 1956 via electron bombardment, which by 1958 covered nearly all and gut varieties for improved efficacy and safety. These developments solidified Ethicon's role within , contributing substantially to the parent company's surgical revenue streams.

Acquisition and Integration with Johnson & Johnson

In 1947, Johnson & Johnson acquired G. F. Merson Limited, a Canadian suture manufacturer, and integrated its operations into the company's existing suture division to enhance production capabilities and market reach. This move built on Johnson & Johnson's foundational work in sterile surgical supplies dating back to , when the company began mass-producing the world's first ready-to-use sterilized sutures and dressings. The acquisition provided access to advanced needle manufacturing techniques and expanded the product portfolio beyond basic sutures. By 1949, formalized the combined suture business as Ethicon Suture Laboratories, a dedicated entity to centralize research, development, and commercialization of wound closure technologies. This restructuring positioned Ethicon as a wholly owned , enabling autonomous operations while leveraging 's distribution networks and financial resources. In 1953, the entity was renamed Ethicon, Inc., marking its evolution into a specialized surgical products company under the umbrella. Integration deepened post-World War II, as Ethicon's market share in surgical sutures surged from 15% to 70% globally, driven by innovations in synthetic materials and sterilization processes supported by Johnson & Johnson's broader R&D infrastructure. The subsidiary retained operational independence for product innovation—such as the introduction of sutures in the —but aligned strategically with Johnson & Johnson's decentralized model, which emphasized credo-guided and global expansion. This structure facilitated Ethicon's diversification into stapling devices and endoscopic tools by the , contributing to Johnson & Johnson's medical devices segment revenue growth without diluting focus on core competencies. In recent decades, Ethicon has been reorganized within 's MedTech division, culminating in a 2024 brand unification where Ethicon products operate under the Johnson & Johnson MedTech banner to streamline marketing and innovation pipelines. This integration has supported acquisitions like NeuWave Medical in 2016 and Megadyne in 2017, enhancing Ethicon's portfolio in energy devices and technologies while maintaining its identity as the originator of modern surgical sutures.

Current Structure and Global Operations

Ethicon, Inc. functions as a within Johnson & Johnson's MedTech segment, concentrating on surgical technologies including wound closure, biosurgery, and devices. Integrated into J&J's decentralized structure, it operates with relative in product development and market strategies while leveraging the parent company's executive oversight and shared resources across Innovative Medicine and MedTech franchises. This model supports focused in , orthopaedics, and other areas, under the leadership of J&J's CEO and segment-specific executives. Headquartered in , Ethicon coordinates global operations from this U.S. base, with manufacturing and R&D facilities distributed across , , , and to ensure supply chain resilience and localized production. Key U.S. sites include , , which houses an 86,000-square-foot Johnson & Johnson Institute for surgical training alongside manufacturing; , for expanded operations; and others in , and Baldwin, Georgia. Internationally, facilities such as the Juarez plant in produce sutures and closure devices, contributing to J&J MedTech's 64 global manufacturing sites. Ethicon's workforce forms part of 's approximately 138,000 employees worldwide as of 2024, with the MedTech segment—including Ethicon—driving operations in over 70 countries through sales, distribution, and clinician collaborations. This global footprint facilitates rapid deployment of technologies like the ENSEAL™ X1 Tissue Sealers and supports training programs via the Institute to enhance surgical outcomes.

Historical Milestones

Innovations in Wound Closure (1880s-1950s)

In 1887, , the precursor to Ethicon's suture operations, introduced the world's first mass-produced sterile surgical sutures, crafted from derived from sheep intestines or silk, which significantly reduced postoperative infection rates and facilitated the adoption of surgical practices in the United States. sutures underwent a meticulous processing method involving soaking in alkaline solutions, splitting into strands, twisting for tensile strength, hand-polishing, and drying to ensure durability and pliability during wound closure. These innovations addressed prior limitations where non-sterile materials often led to , marking a pivotal shift in reliability. During the early 20th century, advancements in suture-needle integration emerged, including the development of eyeless or "atraumatic" needled sutures by George Merson in the , known as Mersutures, which minimized surrounding tissue trauma by permanently attaching a single continuous filament to the needle tip, eliminating the need for separate threading. Johnson & Johnson's suture division, formalized as Johnson Suture Corp. in , expanded production of these materials amid growing surgical demands, particularly during when output surged to meet military needs, with much of the labor-intensive handwork performed by women due to the precision required. By the late 1940s, the suture operations evolved into Ethicon Suture Laboratories in 1949 following the acquisition of Merson's firm, laying the groundwork for dedicated innovation in wound closure; this entity was renamed Ethicon Inc. in 1953. A major breakthrough occurred in 1956–1957 when Ethicon pioneered commercial electron beam radiation sterilization for sutures in collaboration with High Voltage Engineering, bombarding materials with high-energy bursts—up to 800 per second—to eradicate bacteria without the degradation caused by heat methods, resulting in 10–15% improvements in suture strength and flexibility. By 1958, this technique was applied to nearly all Ethicon sutures, including catgut and silk, enhancing product consistency and safety while boosting the company's global market share in surgical sutures from 15% pre-World War II to 70% by the postwar period. These developments underscored a transition from rudimentary sterile packaging to advanced, physics-based preservation, fundamentally improving the efficacy of wound closure devices.

Advancements in Surgical Technologies (1960s-1990s)

During the , Ethicon enhanced suture reliability through the adoption of gamma irradiation sterilization in 1960, a process that bombarded sutures with to eliminate while preserving material strength and flexibility. This method supplanted earlier techniques like gas, reducing contamination risks in surgical settings. Toward the decade's end, in 1969, Ethicon introduced Prolene® polypropylene sutures, a non-absorbable monofilament synthetic designed for high-tensile applications such as cardiovascular , offering superior stretch resistance and minimal tissue reaction compared to or alternatives. The 1970s brought breakthroughs in absorbable materials, with ® synthetic braided sutures launched in 1974, engineered from polyglactin 910 to maintain 75% tensile strength at two weeks post-implantation and fully absorb within 56-70 days, facilitating internal healing without removal. A lubricated for ® followed in 1979, improving knot tie-down and passage through tissue while decreasing inflammation. Ethicon also diversified into mechanical devices with the 1978 release of the Proximate® disposable skin stapler, which deployed staples to close incisions up to ten times faster than manual suturing, thereby shortening operative time, reducing exposure, and lowering cross-infection potential through single-use design. Advancements continued in the with PDS® II monofilament sutures in 1982, providing prolonged support—retaining approximately 70% strength at two weeks and 50% at four weeks—for demanding closures like , with complete absorption over 180 days and reduced suture-related complications. The emphasized minimally invasive tools, including the 1990 introduction of the Endo GIA endoscopic linear cutter, a 30 mm device for articulating tissue transection and stapling in laparoscopic surgery, enabling precise vascular control without large incisions. Monocryl® synthetic absorbable sutures debuted in 1993, featuring a for skin-level use with high knot security and lower infection rates due to smoother . By 1998, DERMABOND® topical skin emerged as a suture alternative, polymerizing to seal superficial wounds rapidly, yielding cosmetic outcomes superior to staples in tensile strength and minimization.

Expansion into Minimally Invasive and Energy Devices (2000s-Present)

In the early , Ethicon Endo-Surgery, a division of Ethicon focused on advanced surgical technologies, accelerated its development of devices tailored for minimally invasive (MIS), leveraging ultrasonic and bipolar energy technologies to enable precise tissue dissection, vessel sealing, and through smaller incisions. This expansion built on the 1995 acquisition of UltraCision Systems, which introduced the LCS 10 ultrasonic shears—a precursor to the ® line capable of cutting and coagulating tissue at lower temperatures than traditional , reducing lateral spread to approximately 1-2 mm. By mid-decade, Ethicon integrated these into laparoscopic platforms, supporting procedures in general, gynecologic, and thoracic , where MIS adoption grew from under 10% of cases in 2000 to over 50% by 2010 in specialties like . Key advancements included refinements to the ® shears, which by the late 2000s offered vessel sealing up to 7 mm in diameter with burst pressures exceeding 600 mmHg, outperforming conventional ties in speed and reducing operative time by up to 20% in randomized trials. Ethicon also expanded bipolar energy offerings with the ENSEAL® family, launched in the 2000s, featuring adaptive resistance technology for consistent sealing across tissue types, minimizing charring and smoke compared to monopolar devices. These innovations addressed limitations in open , such as higher infection rates (up to 5% versus 1-2% in MIS), by facilitating trocar-based access and energy delivery for without excessive formation. The 2010s marked further portfolio growth through strategic acquisitions enhancing MIS and energy capabilities. In 2016, Ethicon acquired NeuWave Medical for an undisclosed sum, integrating the Avecure microwave system—a minimally invasive tool for tumor treatment via or laparoscopic approaches, delivering up to 150 watts of energy for zones up to 5 cm in diameter with real-time temperature monitoring. This complemented existing lines by expanding into interventional . In 2017, the acquisition of Megadyne Medical Products added electrosurgical generators and electrodes, broadening Ethicon's suite with low-impedance tools for precise cutting in laparoscopic settings, though subsequent recalls in 2023 highlighted risks like burns from failures in return electrodes. Into the present, Ethicon has iterated on integrated platforms, such as the 2012 EES GENERATOR combining ultrasonic and bipolar modalities for seamless device switching, and the ®+ Shears, which extended to 23 cm for deeper MIS access while maintaining seal integrity. The 2019 acquisition of Auris for $3.4 billion introduced the ® robotic platform, enabling bronchoscopic navigation for peripheral lung procedures with sub-millimeter precision, reducing rates to under 5% in clinical use. These developments have positioned Ethicon's energy devices in over 10 million annual procedures globally, though independent analyses note variability in outcomes due to technique and tissue properties, underscoring the need for standardized .

Products and Technologies

Sutures and Mechanical Closure Systems

Ethicon's suture portfolio encompasses absorbable and non-absorbable materials tailored for diverse surgical applications, including approximation and ligation. Absorbable sutures, such as COATED ™ (polyglactin 910), are braided synthetic polymers coated for smooth passage through tissue and predictable absorption via , typically retaining 75% tensile strength at 14 days and full absorption in 56-70 days. Monofilament options like PDS™ II () provide prolonged strength retention—up to 50% at 42 days—for closure, minimizing suture-related inflammation compared to multifilament alternatives. Non-absorbable sutures, including ETHIBOND™ EXCEL™ (polyester with poliglecaprone coating) and ™ (), offer high tensile strength and resistance to tissue ingrowth, suited for cardiovascular and orthopedic procedures where permanent reinforcement is required. Mechanical closure systems from Ethicon include linear and circular staplers, as well as clip appliers, designed to expedite hemostasis and tissue approximation while reducing operative time versus traditional suturing. The ECHELON FLEX™ powered stapler features adaptive firing technology with Grip Control that adjusts compression based on tissue thickness, delivering six rows of staggered staples for enhanced leak resistance in gastrointestinal anastomoses. PROXIMATE™ skin staplers, introduced in the late 1970s as disposable devices, deploy stainless steel staples with 3.9 mm leg length for superficial wound closure, promoting even distribution of tension to support healing. LIGACLIP™ appliers, available in multi-fire configurations, apply titanium or polymer clips for vessel ligation in both open and laparoscopic settings, with sizes accommodating vessels up to 7 mm in diameter. These systems integrate ergonomic handles and reloadable cartridges to facilitate precise deployment, with evidence from manufacturer testing indicating lower staple malformation rates than manual alternatives. Innovations in Ethicon's wound closure technologies emphasize biocompatibility and procedural efficiency, such as the integration of antibacterial coatings on using to reduce surgical site infections by up to 30% in clinical evaluations. Early advancements trace to Ethicon's development of chromic gut sutures in the for delayed absorption and the debut of PDS® II in the 1980s for extended wound support, reflecting iterative material refinements to match tissue healing kinetics. Mechanical systems evolved from the 1978 PROXIMATE™ introduction, expanding to powered platforms like the ECHELON™ CIRCULAR in the 2010s, which incorporate automated anvil alignment to minimize anastomotic leaks in . These products are manufactured under standards, with needle-suture combinations optimized via proprietary processes for reduced tissue trauma.

Biosurgery and Hemostatic Agents

Ethicon's biosurgery offerings encompass products that support tissue management and during surgical procedures, with hemostatic agents forming a core component to address intraoperative bleeding challenges such as oozing, re-bleeding, and difficult-to-access sites. These agents function adjunctively alongside conventional techniques like ligation or electrocautery, promoting clot formation through mechanisms including absorption of fluid, platelet activation, and approximation of tissue edges. Clinical evaluations, including randomized controlled trials, have demonstrated their superior efficacy in achieving across various bleeding severities compared to alternatives like . The ™ family of absorbable hemostats, based on oxidized regenerated , is indicated for controlling , venous, and small arterial hemorrhage as an adjunct in procedures where standard methods prove insufficient. Introduced variants such as ™ Original provide a flexible sheet for broad application, while ™ Fibrillar™ and Powder forms conform to irregular surfaces for targeted use in confined spaces, achieving through swelling and low pH-induced . The SNoW™ Absorbable Hemostat, designed for continuous oozing, enables single-layer application with consistent results in laparoscopic and open surgeries. These products are fully absorbable, typically degrading within 1-2 weeks via and enzymatic processes, though they carry risks of encapsulation in infections or promotion of adhesions if not fully removed. Flowable hemostats like SURGIFLO® Hemostatic Matrix consist of a porcine gelatin matrix that expands upon contact with blood, optionally combined with thrombin to accelerate fibrin formation for moderate bleeding in expansive or irregular fields. Approved by the FDA in 2010 for such applications, it supports delivery via syringe for precise placement and has been associated with reduced operative time in vascular and general surgeries. Complementary sealants, including VISTASEAL™ Fibrin Sealant (launched December 3, 2019) and EVARREST® Fibrin Sealant Patch, leverage human-derived thrombin and fibrinogen to replicate physiological clotting, effective for diffuse or coagulopathic bleeding. A notable advancement is the ETHIZIA™ Hemostatic Sealing Patch, introduced on November 15, 2023, which integrates , fibrinogen, and a backing to seal moderate-to-severe bleeding sites, achieving in 30 seconds for 80% of participants—six times faster than standard . These innovations extend to biosurgery's broader role in minimizing blood loss and transfusions, with portfolio-wide data indicating up to 50% faster in challenging scenarios, though long-term outcomes depend on patient factors like . Contraindications include intraluminal vessel use or patients with allergies to components, and neurosurgical applications lack validation in the U.S.

Energy-Based Surgical Devices

Ethicon's energy-based surgical devices employ ultrasonic vibration and advanced bipolar radiofrequency (RF) energy to facilitate precise tissue dissection, vessel sealing, and hemostasis during open and minimally invasive procedures, minimizing thermal damage compared to traditional electrosurgery. These technologies integrate with generators such as the GEN11 and the ETHICON™ Total Energy System, approved by the FDA on January 17, 2025, which support monopolar, bipolar, and ultrasonic instruments. The ® platform utilizes ultrasonic energy, where blades vibrate at 55,500 cycles per second to generate frictional heat that denatures proteins for simultaneous cutting and , enabling vessel sealing up to 7 mm in diameter with reduced lateral thermal spread. First introduced through UltraCision technology with initial surgical application in , ® devices advanced laparoscopic surgery by providing cleaner and lower production than monopolar devices. Key iterations include the ® ACE+7 Shears, featuring a 7 mm closed-tip jaw for enhanced vessel sealing, and the ® FOCUS+ Shears, which demonstrated seal strength equivalent to advanced bipolar devices in bench-top testing as of 2015. The ® 700 with Advanced further incorporates adaptive energy delivery for improved tissue protection in incisions. Complementing ultrasonic offerings, Ethicon's ENSEAL® devices deliver RF via adaptive algorithms to seal vessels up to 7 mm, promoting efficient transection with consistent burst pressures exceeding 600 mmHg in preclinical models. The ENSEAL® X1 Curved Tissue Sealer, launched on June 21, 2021, features intelligent modulation for reduced charring and procedural efficiency in open and laparoscopic settings. The ENSEAL® G2 Articulating Tissue Sealer adds 360° and 110° articulation for maneuverability in complex anatomies. In thoracic applications, the ENSEAL® X1 Curved Jaw has shown effective without significant hemorrhage in clinical evaluations. In March 2025, Ethicon introduced the DUALTO™ Energy System, an integrated platform combining ultrasonic, bipolar, and monopolar modalities to streamline workflows across surgical approaches, addressing variability in energy delivery. These devices, including electrosurgical accessories from the MEGADYNE™ portfolio, emphasize reduced surgical smoke and tissue adherence, though performance claims derive primarily from manufacturer-sponsored bench and preclinical studies requiring independent clinical validation.

Mesh and Soft Tissue Repair Products

Ethicon produces a variety of products for repair, primarily aimed at reinforcing defects in repairs and supporting reconstructions. These include nonabsorbable synthetic meshes, partially absorbable composites, fully absorbable options for temporary support, and biologic matrices derived from animal tissues. The designs emphasize tissue ingrowth, flexibility to reduce sensation, and sometimes barriers to prevent adhesions to viscera. PROLENE Soft Mesh is a nonabsorbable synthetic product made of , offering approximately 50% greater flexibility than standard PROLENE mesh to facilitate handling and conformability during implantation. It is indicated for repairing or fascial defects requiring reinforcement or bridging, suitable for both open ventral and inguinal procedures. Available in various sizes such as 15 cm x 15 cm and 25 cm x 25 cm, it promotes tissue integration through its porous structure while maintaining long-term strength. PROCEED Surgical Mesh features a macroporous, partially absorbable design combining nonabsorbable with bioresorbable oxidized regenerated (ORC) and layers to separate from underlying viscera and minimize attachments. Indicated for laparoscopic or open intraperitoneal ventral repairs, it exhibits bacteriostatic effects against pathogens like MRSA and E. coli , potentially reducing surgical site infections. Clinical data from a study of 157 patients showed significant improvements in and movement at 12 months post-implantation, with 75.1% of cases involving incisional or ventral hernias. The is engineered to withstand intra-abdominal pressures up to specified limits. For temporary support, VICRYL Mesh (polyglactin 910), available in woven or knitted forms, absorbs over time to provide short-term or organ reinforcement during , typically used where permanent material is unnecessary. It is indicated for general approximation in procedures requiring transient scaffolding, with absorption occurring via within 56-90 days. Sizes include 30 cm x 30 cm sheets. Biologic options like XCM Biologic Tissue Matrix, derived from porcine , serve as a non-crosslinked acellular matrix for reinforcement where weakness exists, such as in contaminated fields or complex repairs. Supplied hydrated and ready for use without orientation restrictions, it supports host cell infiltration and vascularization, with storage possible at room temperature. Studies indicate its utility in reinforcement, though long-term outcomes depend on patient factors like risk. In pelvic floor applications, products such as GYNECARE GYNEMESH PS utilize soft mesh for durability and tissue ingrowth in prolapse repairs, while ARTISYN Y-Shaped Mesh employs a bi-directional design for precise fixation in sacrocolpopexy. Ethicon formerly marketed PHYSIOMESH Flexible Composite Mesh, a skirted, microporous partially absorbable device for open ventral hernias, cleared by FDA in 2010, but voluntarily discontinued global sales in August 2016 after an reported higher rates of recurrence (up to 11.5%) and reoperations compared to non-Ethicon meshes.

Research, Development, and Clinical Impact

Key R&D Initiatives and Patents

Ethicon's efforts emphasize advancements in wound closure, biosurgery, and energy-based devices, with a focus on reducing surgical complications such as site infections through surgeon-informed innovations. As part of MedTech, Ethicon contributes to an annual R&D investment exceeding $2.5 billion, supporting over 4,000 scientists and engineers across 28 global sites, which has yielded more than 60 major product launches in recent years and participation in over 375 active clinical studies. A prominent initiative, Project Game Changer, launched in 2015 as a multimillion-dollar global program, aims to address evidence gaps in surgical outcomes, minimize clinical and economic variations, and enhance patient care through data-driven improvements in device efficacy and usage protocols. Complementing this, the Ethicon Surgical Innovations Lab, introduced in 2021 and expanded in 2022, operates as a mobile, fully equipped facility touring U.S. hospitals to facilitate hands-on training, testing, and collaborative development of minimally invasive techniques. These efforts integrate feedback from surgical communities to prioritize technologies that improve and tissue sealing, as evidenced by products like the ETHIZIA Hemostatic Sealing Patch, approved in November 2023 for adjunctive bleeding control in challenging surgical scenarios. Ethicon holds numerous underpinning its core technologies. In energy devices, U.S. Patent No. 7,416,436 (issued 2008) and related claims cover ultrasonic surgical shears for simultaneous tissue cutting and vessel sealing via high-frequency vibrations, enabling precise with reduced thermal spread compared to traditional methods; these have been central to litigation affirming their novelty against competitors. For biosurgery, U.S. Patent No. 7,186,684 (issued 2007) describes hemostatic devices incorporating protein precipitates to accelerate clotting, forming the basis for products like EVARREST Sealant Patches used in vascular reconstructions. In sutures and closure systems, patents such as U.S. Patent No. 12,082,805 (issued ) detail bi-directional barbed sutures with tailored segments for secure wound approximation without knots, reducing operative time and foreign body reaction risks. Recent filings extend to robotic integration, including U.S. Patent No. 12,408,915 (issued ) for robot-controlled applicators dispensing fasteners, enhancing precision in automated minimally invasive procedures. These patents, drawn from Ethicon's extensive portfolio, reflect iterative advancements validated through benchtop and animal model testing, such as superior burst pressure performance in vessel sealing (e.g., 1055 mmHg for ENSEAL X1 devices).

Evidence on Improved Surgical Outcomes

Clinical studies on Ethicon's antibacterial sutures, such as triclosan-coated polyglactin 910 (Vicryl Plus), have demonstrated reduced rates of surgical site infections (SSIs) in certain procedures. A of found that these sutures significantly lowered SSI incidence in clean-contaminated surgeries, with a attributed to properties inhibiting bacterial at the incision site. However, not all trials confirm superiority; a in reported no significant difference in or rates compared to uncoated sutures, suggesting benefits may vary by surgical context and patient factors. Ethicon's ultrasonic energy devices, including the Harmonic scalpel, show consistent evidence of improved outcomes in reducing intraoperative blood loss and operative time across multiple specialties. An umbrella review of randomized controlled trials indicated that Harmonic devices decreased blood loss in 18 studies involving over 1,500 patients, alongside shorter hospital stays and lower drainage volumes compared to conventional techniques like electrocautery. In head and neck , a randomized reported mean blood loss reductions of approximately 50% with Harmonic use versus traditional methods, without increased complication rates. Similar benefits extend to cardiac redo procedures, where Harmonic application correlated with lower postoperative bleeding and better in-hospital recovery metrics. For biosurgery products like hemostatic agents, randomized trials support enhanced in challenging bleeding scenarios, contributing to reduced transfusion needs and operative durations. Four controlled studies across open and minimally invasive surgeries demonstrated superior efficacy in achieving within minutes, outperforming standard methods in mild-to-moderate bleeding control. The ETHIZIA hemostatic patch, evaluated in clinical trials, achieved bleeding cessation in 80% of cases within 30 seconds, potentially minimizing procedural disruptions and associated morbidities like formation. Overall, these outcomes underscore causal links between device-specific mechanisms—such as ultrasonic for vessel sealing or oxidized for clot promotion—and measurable reductions in adverse events, though long-term data beyond 30-day follow-up remains limited in many studies.

Criticisms of Over-Reliance on Proprietary Data

Critics of Ethicon's research practices have highlighted the risks associated with heavy dependence on manufacturer-controlled clinical data, which often lacks the transparency and independent scrutiny afforded by public registries or peer-reviewed studies not sponsored by industry. Proprietary datasets, used extensively in pre-market testing and FDA submissions for devices like hernia meshes, can introduce selection bias, as evidenced by discrepancies between company-reported outcomes and real-world performance. For instance, industry-sponsored trials on surgical meshes have been shown to report more favorable results than independent analyses, potentially overstating efficacy and underestimating long-term complications due to controlled study conditions that do not replicate diverse patient populations. A prominent example is the Physiomesh Flexible Composite Mesh, withdrawn globally by Ethicon in May 2016 after internal review of post-market data from independent European registries revealed reintervention rates of 10.9% at two years, compared to 4.9% for similar non-Ethicon . Pre-approval reliance on proprietary bench testing and short-term studies via the FDA's 510(k) pathway had not anticipated these elevated failure rates, prompting accusations that Ethicon prioritized internal validations over broader, unbiased surveillance. The unpublished registry data from Herniamed () and the Danish Hernia Database, involving over 7,000 cases, underscored how proprietary optimism can delay corrective action, with plaintiffs in subsequent litigation arguing that Ethicon's internal analyses selectively emphasized positive metrics while minimizing signals of shrinkage or . In pelvic mesh litigation, such as Edwards v. Ethicon (2012), courts rejected motions to exclude plaintiff experts who contended that Ethicon's proprietary data presentations ignored contradictory evidence, including higher erosion rates in real-world use versus sponsored trials. This pattern reflects broader concerns in regulation, where FDA approvals often hinge on sponsor-submitted data with limited public disclosure, fostering skepticism about claims of superior outcomes—such as reduced anastomotic leaks with Ethicon staplers—derived primarily from company-initiated studies rather than head-to-head independent comparisons. While Ethicon maintains that its data supports product safety, the reliance on non-transparent internal metrics has fueled demands for mandatory post-market independent audits to mitigate inherent conflicts of interest in industry-funded .

FDA Approvals and Recalls

Ethicon products have received extensive FDA clearance through the 510(k) premarket notification process, which deems devices substantially equivalent to existing predicates, as well as some premarket approvals (PMAs) for higher-risk items. For instance, the ETHICON™ Total Energy System, an energy-based surgical device, was cleared on January 17, 2025, for use in tissue sealing and cutting during laparoscopic procedures. Sutures such as the Ethicon Endosuture System have undergone PMA supplements, with approvals dating back to the 1980s and ongoing modifications cleared as recently as 2021 for soft tissue approximation. Composite meshes like Physiomesh Flexible were 510(k)-cleared in 2010 for hernia repair, though later subject to withdrawal. Recalls and corrections have primarily involved Class 2 actions for issues like packaging defects, sterility lapses, and manufacturing inconsistencies, alongside rarer Class 1 events. In July 2025, Ethicon Endo-Surgery issued a Class 1 correction for Endopath Echelon Vascular White Reload cartridges used in surgical staplers, due to potential locking that could cause tissue damage, bleeding, or surgical delays; this followed reports including one death and multiple adverse events, prompting instructions to inspect and quarantine affected units without physical removal. Suture products have seen repeated Class 2 recalls, such as the 2022 voluntary removal of PDS II (polydioxanone) sutures due to low tensile strength in one lot, and 2021-2022 actions for VICRYL and PDS Plus sutures over packaging failures allowing moisture ingress and potential non-sterility. ETHIBOND EXCEL Polyester Suture faced a 2025 Class 2 recall for similar sterility concerns from inadequate sealing. Hernia mesh products drew significant scrutiny, with Ethicon initiating a voluntary global recall of Physiomesh Flexible Composite on May 25, 2016, after post-market data from registries showed higher reoperation rates (up to 11% within two years) compared to other meshes, attributed to potential mesh folding or coating issues during laparoscopic ventral ; the FDA classified this as a field action but did not mandate it. For transvaginal mesh, Ethicon's Gynecare products (e.g., Prolift kits) were impacted by FDA safety communications in 2011 highlighting risks like and , leading to voluntary withdrawals; the agency ordered all manufacturers, including Ethicon, to cease U.S. sales of transvaginal pelvic organ prolapse (POP) in April 2019 due to disproportionate risks versus benefits, reaffirming the ban in 2022 after reviewing safety data showing complications in 10% of cases within one year. Earlier Class 2 recalls included Proceed Surgical from 2005-2014 for packaging tears and Proceed Ventral Patch in 2015 for lack of FDA registration.
Recall EventProductDate InitiatedFDA ClassificationReason
Endopath Echelon Vascular ReloadSurgical stapler cartridgesJuly 2025Class 1 (Correction)Potential locking leading to misfires, tissue injury, or death
Physiomesh Flexible Composite MeshHernia repair meshMay 2016Voluntary (Field Safety Notice)Elevated reoperation rates from mesh complications
PDS II SuturesAbsorbable suturesMay 2022Class 2Low tensile strength in affected lot
Transvaginal POP Mesh (Gynecare)Pelvic support kitsApril 2019 (FDA Order)Cease DistributionHigh risks of erosion, pain, and recurrence vs. non-mesh alternatives
The Gynecare Prolift, introduced by Ethicon in 2005 as a mesh kit for transvaginal repair of (POP), involved placing mesh through small incisions to support weakened vaginal walls in anterior, posterior, or total configurations. Early post-market reports documented complications such as mesh erosion into vaginal tissue, , , infections, and organ perforation, with some requiring surgical revision or explantation. Ethicon marketed the device under the 510(k) clearance pathway without full premarket approval for its specific transvaginal use, distributing it for three years prior to FDA scrutiny. In October 2008, the FDA issued an initial safety communication classifying transvaginal mesh complications as "rare" but noting risks like and pain, based on analysis of over 1,000 reports from 2005-2008. By July 2011, following review of approximately 3,000 additional reports through 2010, the FDA updated its stance, stating that serious complications—including , , and need for multiple surgeries—were "not rare" for transvaginal POP repairs, and recommended against such use due to risks outweighing benefits compared to traditional non-mesh surgeries. This communication did not apply to mid-urethral slings for (SUI), where evidence supported continued use. Ethicon responded in June 2012 by voluntarily discontinuing U.S. sales of Prolift, Prosima, and certain Gynemesh products for transvaginal POP repair, while affirming confidence in their overall safety and efficacy based on clinical data; the move was not classified as a recall. Internal documents later revealed in litigation indicated Ethicon had awareness of risks exceeding 10% in some studies as early as , yet continued promotion without updating warnings adequately. Lawsuits against Ethicon alleging defective design, manufacturing flaws, and failure to warn proliferated post-2011, consolidating into Multidistrict Litigation (MDL) No. 2327 in the U.S. District Court for the Southern District of , encompassing thousands of claims specifically involving Prolift and related transvaginal meshes like TVT-O. By 2019, over 40,000 vaginal mesh suits had been filed industry-wide, with Ethicon facing more than 5,950 individually. Plaintiffs contended the non-absorbable mesh contracted and degraded , causing and migration, while Ethicon defended by attributing issues to surgical technique or patient factors rather than inherent defects. Bellwether trials yielded mixed but predominantly plaintiff-favorable outcomes for Prolift cases. In 2013, a state court upheld an $11.1 million verdict for Linda Gross, who experienced severe pain and multiple surgeries after Prolift implantation, finding Ethicon liable for design defects and inadequate warnings. A jury awarded $2.1 million in 2014 to a suffering erosion and from Prolift deterioration. In 2019, another verdict reached $80.025 million ($5 million compensatory, reduced from higher initial awards, plus ) for Patricia Mesigian's Prolift-related injuries including erosion and following 2008 implantation. Ethicon resolved numerous claims through confidential settlements, including a $120 million agreement in January 2016 covering over 3,000 cases involving Prolift and similar devices, with individual payouts ranging from $40,000 to $450,000 based on severity and . Additional state-level resolutions included $9.9 million to in February 2023 for failure to disclose risks. By 2025, the federal MDL had largely dismantled, with remaining cases remanded or settled, though Ethicon continued defending select trials and appealing verdicts like California's $302 million judgment upheld by the U.S. in 2023. Ethicon's Physiomesh Flexible Composite Mesh, intended for laparoscopic ventral , was voluntarily withdrawn from the global market on May 25, 2016, following an internal analysis of post-market registry data from two independent European databases indicating higher-than-expected rates of serious complications, including , mesh contraction, and reoperation within 24 months post-implantation. The product had been marketed since March 2010, with Ethicon notifying surgeons via an urgent field safety notice to cease use and return unused inventory, though the withdrawal was not classified as a formal recall by regulatory bodies like the FDA. Lawsuits against Ethicon and its parent allege defective design, manufacturing defects, and failure to adequately warn of risks such as , infections, adhesions, and the need for revision surgeries, with claims centered on implants placed between March 2010 and May 2016. Over 3,600 such cases were consolidated in multidistrict litigation (MDL No. 2782) in the U.S. Court for the Northern of Georgia, where plaintiffs contend the mesh's multi-layer composite structure, including a bioresorbable , contributed to degradation and inflammatory responses not sufficiently disclosed in labeling. Ethicon has defended by arguing the registry data reflected factors like technique and patient comorbidities rather than inherent product flaws, though no bellwether trials reached by late 2023. Proceed Surgical Mesh, a partially absorbable polypropylene-based product for ventral and repairs, has faced separate litigation alleging similar defects, including coating delamination leading to foreign body reactions, seromas, and fistulas. In state courts, the Supreme Court designated Proceed-related cases for centralized multicounty litigation in Atlantic County , encompassing claims of inadequate testing and misrepresentation of despite known issues with the oxidized regenerated cellulose layer. Plaintiffs in Proceed suits, filed as early as 2016, report complications necessitating explantation, with allegations that Ethicon prioritized market expansion over long-term safety data. Related Ethicon hernia meshes, such as , have been implicated in fewer but overlapping claims within the same MDL dockets, primarily for alleged migration, , and chronic in open and laparoscopic procedures. By December 2023, reached confidential settlements resolving over 200 Physiomesh cases in Georgia, prompting dismissals, though broader Ethicon hernia mesh resolution terms remain undisclosed and litigation continues in state courts. Earlier, Ethicon settled 10 individual claims without admitting liability. No public verdicts have been reported specifically for Ethicon products as of October 2025, contrasting with outcomes in parallel litigations against competitors like C.R. Bard.

Recent Developments

Settlements and Verdicts (2020-2025)

In 2020, a state court ordered Ethicon to pay approximately $344 million to resolve claims alleging failure to warn about risks associated with its transvaginal mesh products, including the Gynecare Prolift device. This judgment stemmed from evidence that Ethicon inadequately disclosed complication rates such as mesh erosion and , though the company contested the ruling's scope. From 2020 to 2025, Ethicon resolved thousands of transvaginal lawsuits through confidential settlements, with individual awards typically ranging from $40,000 to $450,000 based on factors like severity, number of revision surgeries, and documented complications including organ and . By October 2025, roughly 95% of filed transvaginal cases against Ethicon and other manufacturers had concluded via settlements or verdicts, leaving a shrinking inventory for amid multidistrict litigation consolidation. Plaintiff attorneys reported average payouts of $150,000 to $900,000 for successful claims, though Ethicon maintained that its devices underwent FDA clearance and that adverse outcomes often related to surgical technique rather than design flaws. In the hernia mesh domain, Ethicon quietly settled 224 cases in federal multidistrict litigation by 2023, primarily involving Physiomesh products recalled in 2016 for high failure rates including migration and recurrence of . A broader global resolution for Physiomesh claims was announced in May 2022, encompassing both U.S. and international plaintiffs, but settlement figures remained undisclosed to avoid influencing ongoing negotiations. In November 2024, Ethicon finalized settlements with ten additional hernia mesh plaintiffs, again without public disclosure of terms, as part of efforts to address allegations of inadequate durability and in products like Proceed and Physiomesh. Jury verdicts during this period yielded mixed outcomes. In February 2023, the U.S. declined to review a $100 million award (upheld from a lower court) against and Ethicon in an Idaho transvaginal case, where jurors found the company liable for defective design and fraudulent marketing despite FDA approvals. Earlier, a Philadelphia jury awarded $41 million in 2020 against Ethicon for Prolift-related injuries, apportioning fault to the device's propensity for , though appeals reduced compensatory portions. These results highlighted tensions between regulatory clearance and post-market evidence of harms, with Ethicon arguing that verdicts overlooked discretion and patient-specific risks. Overall, hernia settlements reportedly contributed to industry-wide payouts exceeding $2 billion by 2025, though Ethicon-specific allocations were not itemized publicly.

Ongoing Innovations and Market Adaptations

In recent years, Ethicon has focused on advancing surgical stapling technologies to enhance staple line integrity and reduce complications such as leaks and bleeding. The ETHICON™ 4000 Stapler, launched on June 10, 2025, incorporates proprietary 3D staple technology and a redesigned , achieving a 23% reduction in staple line interventions due to bleeding compared to prior models, with exclusive future integration planned for the OTTAVA™ Robotic Surgical System. Similarly, the ECHELON™ 3000 Stapler, introduced on July 2, 2024, features one-handed powered articulation, a greater aperture, and 27% improved articulation range for better access in complex procedures. The ECHELON LINEAR™ Cutter, released May 27, 2024, demonstrated 47% fewer staple line leaks in preclinical testing, aiming to mitigate risks in gastrointestinal and thoracic surgeries. Ethicon has also expanded its biosurgery offerings with hemostatic solutions for intraoperative bleeding control. The ETHIZIA™ Hemostatic Sealing Patch, cleared for use in November 2023, provides rapid sealing for disruptive bleeding on internal organs (excluding the heart and ), complementing Ethicon's existing portfolio of sealants and topical hemostats backed by on . In energy-based devices, the DUALTO™ Energy System, launched March 25, 2025, integrates multiple modalities (including advanced bipolar, ultrasonic, and hybrid energies) into a single platform for both open and minimally invasive procedures, enabling surgeons to switch tools without changing devices. Market adaptations reflect a strategic pivot toward and integrated systems amid heightened regulatory scrutiny on implantable meshes, following voluntary withdrawals of products like Physiomesh in 2016 and subsequent litigation resolutions through 2023. Ethicon's innovations emphasize compatibility with robotic platforms, as seen in the first clinical cases of the OTTAVA™ system on April 14, 2025, which leverages Ethicon staplers for procedures and addresses limitations in existing like limited articulation. This shift prioritizes technologies with demonstrated reductions in adverse events, supported by preclinical and early clinical evidence, to align with demands for safer, more precise while expanding minimally invasive options globally.

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