Fact-checked by Grok 2 weeks ago

Coloplast

Coloplast A/S is a Danish company founded in 1957, specializing in products and services for intimate healthcare needs such as ostomy care, continence care, , advanced wound care, and voice and respiratory care. Headquartered in Humlebæk, , it employs approximately 16,500 people across 41 countries and sells its offerings in more than 100 nations, assisting over 2 million individuals annually with adhesive-based solutions derived from its pioneering ostomy bag invention. The company's origins trace to nurse Elise Sørensen's innovation of the world's first disposable ostomy bag to aid her post-surgery, leading founders Aage and Johanne Louis-Hansen to establish Coloplast and expand into global markets through empathy-driven product development. Its mission emphasizes tailoring solutions to users' physical and emotional challenges, fostering sustained —evidenced by 2023/24 revenue of DKK 27,030 million, up 10% reported—and strategic acquisitions like wound care firm Kerecis to bolster its portfolio. While Coloplast has maintained market leadership via innovations in skin-friendly adhesives and user-centric designs, it has encountered controversies, notably multidistrict litigation over transvaginal mesh products for , resulting in settlements such as $16 million for 400 cases and upheld judgments like $2.5 million for alleged defects causing complications including mesh erosion. These legal challenges highlight risks in implantable devices, though the firm continues prioritizing and product amid empirical scrutiny of long-term efficacy.

Corporate Overview

Founding and Core Mission

Coloplast originated in in 1957, founded by civil engineer and plastics manufacturer Aage Louis-Hansen alongside his wife Johanne, a trained nurse. The impetus for the company stemmed from an innovation conceived in 1954 by Danish nurse Elise Sørensen, who created a prototype disposable ostomy bag to address the challenges faced by her sister Thora following a colon removal due to cancer; Thora's fear of leakage and odor had confined her indoors, highlighting the need for discreet, reliable management solutions. Louis-Hansen adapted Sørensen's concept into production using his expertise in plastics, marking the development of the world's first ostomy bag and establishing Coloplast's initial focus on practical aids for post-surgical patients with intimate care requirements. From its inception, Coloplast's core has centered on alleviating the daily burdens of individuals with private , encapsulated in the stated purpose: "to make life easier for people with intimate healthcare needs." This directive prioritizes product development grounded in direct user input, extending beyond clinical efficacy to encompass emotional and social dimensions of conditions like ostomies, emphasizing durable, user-friendly designs that enable greater and . The mission's persistence reflects the company's foundational commitment to targeted in underserved areas of personal healthcare, driven by empirical observation of patient realities rather than broad institutional agendas.

Global Operations and Market Position

Coloplast maintains a decentralized global manufacturing network optimized for efficiency and proximity to markets, with primary production sites in (accounting for approximately 90% of global operations), , , , , and the , alongside a new facility established in in 2023 to support expansion. The company employs around 13,000 people worldwide and distributes its products across more than 140 countries, enabling localized supply chains and in diverse markets. This structure supports high-volume production of medical devices while minimizing costs through , a strategy initiated in the early that relocated nearly 90% of manufacturing from Denmark by 2011. In ostomy care, Coloplast holds a dominant market position, commanding about 40% share in Europe and roughly double that proportion globally, driven by innovations in pouching systems and strong penetration in mature markets like the U.S., where its share has doubled to 20% over the past decade. The company leads in continence and urology solutions, particularly intermittent catheters, with consistent organic growth of 7-10% in these segments as of fiscal year 2024/25. In advanced wound care, it occupies a number-five global ranking with 5-10% market share, focusing on hydrocolloid-based dressings amid fragmented competition. Overall, Coloplast's emphasis on chronic care categories positions it as a top-tier player in the medical device sector, with reported organic revenue growth of 7% in the first nine months of 2024/25, though tempered by currency headwinds and product recalls in interventional urology.

Business Segments and Revenue Breakdown

Coloplast operates in five primary business areas within the intimate healthcare sector: Ostomy Care, Continence Care, Advanced Wound Care, Interventional , and Voice and Respiratory Care. These segments focus on medical devices and solutions for chronic conditions, emphasizing patient intimacy and clinical efficacy. Ostomy Care provides pouches, baseplates, and accessories for individuals with stomas resulting from surgery for conditions like or . Continence Care offers intermittent catheters, urine collection bags, and bowel management products for urinary and . Advanced Wound Care includes absorbent dressings such as Biatain® and biologics like fish-skin grafts from the Kerecis acquisition for chronic and surgical wounds. Interventional Urology encompasses implantable devices for male and female pelvic health, including slings, meshes, and endourological tools. Voice and Respiratory Care supplies heat-and-moisture exchangers, voice prostheses, and adhesives for patients post-laryngectomy or tracheostomy. For the fiscal year 2023/24, ending September 30, 2024, Coloplast reported of DKK 27,030 million, reflecting 10% reported growth and 8% at constant exchange rates. The Chronic Care category, comprising Ostomy Care and Continence Care, accounted for the largest share at DKK 18,085 million, or approximately 67% of .
Business AreaRevenue (DKK million)Share of Total (%)Organic Growth (%)
Ostomy Care9,545357
Continence Care8,540328
Advanced Wound Care4,1001510
Interventional Urology2,800105
Voice and Respiratory Care2,110811
Total27,0301008
Ostomy Care generated DKK 9,545 million, driven by market share gains in mature markets and volume growth in emerging regions. Continence Care contributed DKK 8,540 million, with broad-based expansion across customer segments including and institutional users. Advanced Care reached DKK 4,100 million, boosted by 35% underlying growth in biologics (DKK 1,026 million), primarily from Kerecis tissue-regeneration products. Interventional reported DKK 2,800 million, with balanced contributions from (40%), women's health (20%), and endourology (40%). Voice and Respiratory Care delivered DKK 2,110 million, supported by innovation in adhesives and prostheses amid demographic tailwinds from aging populations. Operating profit before special items across segments totaled DKK 7,286 million, yielding a 27% EBIT margin, indicative of the company's focus on efficiency and pricing discipline.

Historical Development

Early Years and Product Origins (1957–1980s)

In 1954, Danish nurse Elise Sørensen developed the concept for the world's first disposable ostomy pouch after her sister Thora underwent a following colon cancer surgery at age 32, facing issues with leakage, odor, and cumbersome reusable bags secured by tape. Sørensen, motivated by her sister's reluctance to venture outdoors due to these limitations, envisioned a pouch with an integrated ring to create a secure, skin-friendly seal. She collaborated with Aage Louis-Hansen, a specializing in plastic packaging, who recognized the potential despite initial market skepticism, as ostomy patients numbered only a few thousand in at the time. Aage Louis-Hansen, assisted by his wife Johanne—a nurse—refined the using available and , leading to the formal establishment of Coloplast in 1957 in Humlebæk, , dedicated to these innovative ostomy bags. The company's inaugural product, launched that year, featured a transparent plastic pouch attached via a soft, pliable border, marking a shift from non-adhesive, labor-intensive alternatives and enabling greater and discretion. Early production was modest, with Coloplast operating from a small facility and focusing on domestic distribution through pharmacies and hospitals, as the product addressed a niche but unmet need in post-surgical care. Throughout the and , Coloplast iterated on its ostomy portfolio, incorporating improvements in material durability and fit to reduce , while beginning limited exports to neighboring European countries amid growing awareness of ostomy procedures. By the , the firm had solidified its position in ostomy care, introducing enhancements like better odor control mechanisms, though it remained primarily a single-product specialist until broader diversification efforts emerged. This period laid the foundation for Coloplast's emphasis on , driven by direct input from healthcare professionals and patients rather than broad market demands.

Expansion and Public Listing (1990s–2000s)

During the 1990s, Coloplast pursued through and , achieving turnover exceeding DKK 1 billion in the 1997/98 , an 11% increase that reflected gains in across major regions. The company emphasized internal development, launching products that contributed to higher-than-expected from prior initiatives, without relying on acquisitions during this period. By the late , Coloplast outlined ambitious targets, aiming for turnover surpassing DKK 6 billion by 2005 through sustained annual expansion. This materialized in the 1999/2000 with an 18% reported turnover growth to DKK 3,603 million (12% in local currencies) and operating profit of DKK 564 million, yielding a 16% margin. Entering the , international operations expanded, establishing presence in over 50 countries by the decade's start, which supported broader distribution of ostomy and related care products. A pivotal inorganic step occurred in 2006, when Coloplast acquired Mentor Corporation's division for $463 million, bolstering its continence care and interventional segments with established technologies like penile implants. This deal prompted relocation of North American headquarters to , enhancing operational efficiency in the U.S. market. These moves diversified revenue beyond core ostomy products while leveraging the company's listing on the Stock Exchange since 1983 to fund strategic initiatives.

Recent Milestones and Strategic Evolution (2010s–2025)

In the 2010s, Coloplast accelerated expansion in and continence care through strategic acquisitions and product enhancements, emphasizing integration into chronic care markets. The 2010 acquisition of Mpathy Medical strengthened its female pelvic health portfolio for a minimum of $30 million, targeting solutions. In 2016, the company acquired Comfort Medical, a U.S.-based supplier of s and ostomy products, for $160 million, which bolstered North American distribution and recurring revenue streams. Product innovations included the 2016 launch of SpeediCath Flex, a flexible intermittent designed for improved user insertion and reduced friction. These moves supported organic revenue growth amid global , with a focus on efficiency and localized operations following earlier relocations from . The 2020s marked further inorganic growth via high-value acquisitions and technological advancements in infection prevention and biologics. In November 2020, Coloplast acquired Nine Continents Medical to incorporate implantable stimulation devices for treatment. The 2023 purchase of Kerecis, a biologics care firm, for up to $1.3 billion expanded its advanced management capabilities using fish-skin-derived grafts. Acquisitions of Medical and IncoCare further diversified voice and offerings. Key product milestones included the February 2023 debut of the Luja male intermittent , incorporating over 80 micro-holes to promote complete emptying and lower urinary tract infection risks, with a female variant featuring Micro-hole Zone Technology launching in May 2024 across major markets. These initiatives drove 7% revenue growth in fiscal 2020/21, reported at DKK 18.5 billion. Strategically, Coloplast evolved toward customer-centric, scalable care models, integrating digitalization, , and as core themes by the late 2010s. The September 2025 Capital Markets Day introduced the Impact4 five-year strategy, aiming to support 4 million individuals with intimate medical needs through enhanced offerings, efficiency gains, and EBITA growth exceeding market rates, while building on prior priorities like Strive25's 7-9% targets. This period saw challenges, including a 2025 full-year guidance downgrade due to softer results in interventional and transitions, yet acquisitions and launches aligned with long-term ambitions in biologics and reduction.

Products and Technological Innovations

Ostomy Care Portfolio

Coloplast's ostomy care portfolio comprises disposable pouches, baseplates, and accessories engineered to manage output from stomas created via surgical procedures such as colostomies, ileostomies, and urostomies, with an emphasis on minimizing leakage risks and preserving peristomal skin integrity. The portfolio features adaptive technologies like elastic adhesives and contoured barriers that accommodate abdominal variations, including hernias and scars, to enhance user security and discretion. Central to the lineup is the SenSura Mio series, which incorporates BodyFit —a double-layer with an "footprint" that flexes with body movements to seal against uneven surfaces and reduce incidents of detachment or leakage. Available in one-piece and two-piece configurations, including drainable and closed-end variants, SenSura Mio options support both and flat profiles for shallow or retracted stomas; for instance, the soft variant provides gentle protrusion for post-surgical . In May 2024, Coloplast expanded this line with a black-colored SenSura Mio pouch, reimbursed in select European markets, to address aesthetic preferences for users seeking less visibility under clothing. Complementary accessories include the Brava Protective Sheet, a silicone-based barrier that absorbs excess moisture to prevent under pouches, and the Brava Ostomy Support Belt, which secures the appliance against physical strain without compressing the . The Alterna range offers mechanical coupling systems for two-piece setups, featuring erosion-resistant adhesives for extended wear times of up to several days. These elements collectively address common complications like and output spillage, supported by clinical evidence indicating lower revision rates with adaptive designs compared to rigid alternatives. In the global ostomy care market, valued at approximately USD 3.47 billion in 2025, Coloplast maintains a leading position with 35-40% , driven by portfolio innovations that prioritize empirical fit-testing across diverse body types. The segment reported 6% organic revenue growth in the first nine months of fiscal 2024/25, reflecting sustained demand amid rising ostomy procedures linked to colorectal conditions.

Urology and Continence Solutions

Coloplast's and continence solutions address , , and related neurogenic or urological conditions through non-invasive management devices and interventional surgical products. The continence care segment focuses on bladder and bowel management for patients with conditions such as injuries, , or prostate issues, while interventional urology targets surgical treatments for stress urinary (SUI), (ED), and . These offerings stem from internal developments and the 2006 acquisition of Mentor Corporation's for $463 million, which expanded Coloplast's portfolio and established it as a global leader in urological devices. In continence care, intermittent form a core product line, including the SpeediCath family, introduced as the first instantly ready-to-use hydrophilic-coated to simplify intermittent self-catheterization and reduce urethral trauma. SpeediCath features Triple Action Coating , which ensures the hydrophilic layer remains bonded, smooth, and hydrated during use, thereby minimizing risks and discomfort—addressing user concerns where 84% fear urinary tract (UTIs) and 42% report pain as a barrier. The Luja catheter incorporates Micro-hole Zone with over 50 micro-holes to enable complete emptying, further lowering UTI incidence compared to traditional eyelet designs. Complementary products include Conveen Urisheaths, discreet external paired with urine bags for non-invasive incontinence management, and the Peristeen Plus transanal , which uses a rectal to instill water for stool evacuation in patients with neurogenic bowel dysfunction, promoting continence for up to 48 hours. Interventional urology products emphasize and devices for durable outcomes in surgical settings. For male , the Virtue Male Sling System provides sub-classification support to restore continence post-prostatectomy. In women, the Altis Single Incision Sling treats via a targeting urethral hypermobility. For ED, the Titan Inflatable Penile offers a long-term solution with biocompatible materials for reliable rigidity and concealment. Additional innovations include endourology tools like the TFL Drive, utilizing fiber laser technology for precise , treatment, and soft tissue procedures, enhancing surgical efficiency and patient safety. These solutions integrate with Coloplast's support programs, such as Coloplast Care, providing education to optimize user adherence and clinical results.

Wound and Skin Care Offerings

Coloplast's wound care portfolio encompasses advanced dressings and antimicrobial solutions tailored for managing exuding, infected, and chronic s, emphasizing moist environments to promote repair and reduce risks. The Biatain® family of dressings, including Biatain® Foam and Biatain® Alginate Ag, absorbs effectively while maintaining a stable structure to minimize of surrounding ; the silver-impregnated variants, such as Biatain® Ag Adhesive, release ionic silver to combat bacterial proliferation in moderately to highly exuding s. Comfeel® Plus dressings, available in transparent and variants, provide a hydrocolloid-based seal that supports autolytic and is indicated for low to moderately exuding s, including pressure s and leg s. For cavity and sloughy , Biatain® Fiber Ag offers gelling fibers that conform to irregular wound beds, facilitating removal of debris while delivering antimicrobial action against a broad spectrum of pathogens. Physiotulle® and Purilon® Gel address non-infected by providing non-adherent contact layers and hydrogel formulations that hydrate dry and support formation, respectively. ® Hydrophilic Wound Dressing, a oxide-based paste, is applied directly to moist or periwound skin, adhering even in wet conditions to fill cavities and protect against leakage, suitable for partial and full-thickness . Skin care offerings complement wound management by focusing on periwound integrity and prevention of moisture-associated , particularly in patients with incontinence or ostomy-related leakage. InterDry® Ag Sheets, impregnated with silver and AST-20® , are placed in to wick away moisture and inhibit microbial growth, reducing the incidence of intertriginous . Barrier products like Brava® Skin Barrier Spray form a sting-free, breathable film to shield intact or irritated periwound from , while Coloplast® Paste fills gaps for enhanced of dressings or appliances. These solutions integrate with broader protocols, supported by educational resources such as the HEAL program, which provides clinician training on evidence-based application to optimize outcomes in diverse wound etiologies.

Interventional Urology Devices

Coloplast's Interventional Urology devices comprise a range of surgical implants and tools designed for minimally invasive treatments of urological and gynecological conditions, including , male and female , , benign prostate hyperplasia, urinary stone disease, and voiding dysfunctions. These products emphasize durability, ease of implantation, and reduced complication rates, supporting procedures from prosthetic implantation to endourologic interventions. In prosthetic urology, focused on men's health, Coloplast offers penile prostheses for , such as the Titan® Inflatable Penile Prosthesis and Titan Touch®, which provide on-demand rigidity via a fluid-filled implanted surgically to restore natural-like function in patients unresponsive to medications or other therapies. The company also provides the Genesis® malleable implant as a simpler, semi-rigid alternative for patients preferring less mechanical complexity. For male stress urinary incontinence, particularly post-prostatectomy, the ® Male Sling uses a quadrangular geometry to support the bulbar , enabling tension-free placement and improved continence outcomes in clinical studies. Testicular prostheses are available for replacement following , constructed from biocompatible to mimic natural and address psychological impacts of loss. Pelvic floor reconstruction devices target female stress urinary incontinence and prolapse, with the Altis® Single Incision Sling featuring a polypropylene mesh delivered via a minimally invasive approach to elevate the bladder neck, reducing operative time and recovery compared to traditional retropubic slings. These products support prolapse repair but have faced scrutiny in regulatory contexts for mesh-related complications, as noted in broader industry litigation. Endourology offerings include disposable tools for stone management and prostate procedures, such as Dormia® stone extractors for retrieving calculi from the or during ureteroscopy, and ureteral stents to maintain drainage post-intervention. The ImaJin® Hydro facilitates hydrophilic access for , while the TFL Drive (60W) enables precise , ablation of soft tissue, and treatment of benign prostate hyperplasia by vaporizing obstructive tissue with minimal thermal damage to surrounding structures. These devices support over a century of endourologic tracing to Coloplast's early product lines.

Growth Strategies and Acquisitions

Key Acquisition History

Coloplast's acquisition strategy has focused on bolstering its core areas of ostomy care, continence, , and wound care through targeted purchases of complementary technologies and market access. A pivotal early move was the 2006 acquisition of Mentor Corporation's business for DKK 2.9 billion (approximately USD 463 million), completed in June of that year, which significantly expanded Coloplast's global footprint in continence and products, including catheters and surgical devices, and added key manufacturing and R&D capabilities . In December 2016, Coloplast acquired Comfort Medical, a U.S.-based supplier of ostomy and continence products, for USD 160 million, enhancing its distribution network and efficiency in , particularly for home delivery services. This deal integrated Comfort's established customer base and logistics into Coloplast's operations, supporting in the U.S. market. In 2020, the company purchased Nine Continents Medical, Inc., a developer of implantable tibial nerve stimulation devices, for USD 145 million, introducing innovative therapies to address and , thereby diversifying its continence portfolio with minimally invasive solutions. The 2021 announcement of Atos Medical's acquisition for €2.16 billion (about USD 2.5 billion), completed in January 2022, marked Coloplast's largest deal to date and introduced the Voice and Respiratory Care business area, specializing in laryngectomy and tracheostomy products, which added approximately 7% to annual revenue and expanded into new patient segments. Most recently, in July 2023, Coloplast agreed to acquire Kerecis, an Icelandic biologics firm using fish-skin grafts for wound healing, for up to USD 1.3 billion, with the deal closing in August 2023; this strengthened the advanced wound care segment by providing differentiated tissue-regeneration products and robust U.S. commercial infrastructure.
YearTargetDeal ValueStrategic Focus
2006Mentor Urology BusinessUSD 463 millionUrology and continence expansion
2016Comfort MedicalUSD 160 millionU.S. distribution and supply chain
2020Nine Continents MedicalUSD 145 millionNeuromodulation for continence
2022Atos MedicalUSD 2.5 billionVoice and respiratory care entry
2023KerecisUp to USD 1.3 billionBiologics wound care innovation

Corporate Strategies and Initiatives (e.g., Impact4)

In September 2025, Coloplast announced Impact4, its new five-year corporate strategy spanning fiscal years 2026 to 2030, succeeding the prior Strive25 framework that targeted 7-9% annual organic revenue growth. Impact4 centers on customer needs in chronic and acute care, with an overarching ambition to assist 4 million people globally through improved product access, reimbursement enhancements in approximately five key markets, and elevated care standards. The strategy emphasizes organic growth over major mergers and acquisitions, limiting the latter to bolt-on deals, while integrating operational efficiencies and technological advancements to outpace market expansion of 4-5%. Impact4 delineates four core strategic priorities: first, fostering via innovative customer offerings that establish new care benchmarks and deepen customer centricity; second, achieving advanced efficiency through complexity reduction and process optimizations under the Plan 7; third, adopting technologies such as to enhance user experiences and enable scalable programs; and fourth, building a sustainable by nurturing a customer-focused culture and robust . These priorities underpin financial targets including a 7-8% (CAGR) in , absolute EBIT matching or exceeding in constant currencies before special items, and return on invested (ROIC) surpassing 20% by 2029/30 with progressive annual improvements. Supporting metrics encompass at 4-5% of , tapering to around 4% by period-end; net at approximately 24% of ; net to EBITDA at about 1.5x; and a of 60-80% of net profit, assuming stable macroeconomic conditions and a rate near 22%. Sustainability forms a pillar of Impact4, with commitments to reduce Scope 1 and 2 by 90% and Scope 3 emissions per product by 10% by 2029/30, alongside achieving by 2045 and cutting material use in products and by 15-20%. Complementary initiatives include a 2025 reorganization into Chronic Care and business units to streamline focus on core segments, alongside product innovations such as the Luja intermittent line and the forthcoming Intibia device pending regulatory approval in 2026-2027. Employee engagement targets placement in the top industry , reinforcing internal capabilities for execution.

Financial Performance and Economic Impact

Coloplast has demonstrated consistent revenue expansion since its public listing in 1983, with compound annual growth rates typically ranging from 8% to 10% over multi-decade periods, fueled by sales increases in chronic care segments and bolt-on acquisitions. In the 1999/2000 , the company reported 18% year-over-year turnover growth, reflecting early momentum in ostomy and continence products amid expanding global markets. By the , revenue had scaled significantly through geographic diversification and , achieving average of 6-8% annually, supplemented by inorganic contributions that elevated total reported growth to double digits in several years. Profitability metrics have remained robust, with operating margins (EBIT before special items) improving from 16% in 1999/2000 to the 27-33% range in the 2020s, attributable to operational efficiencies, optimizations, and a focus on higher-margin recurring consumables. For instance, in 2022/23, reported reached DKK 24,500 million with 8% and a 28% EBIT margin before special items. The following year, rose to DKK 27,030 million, maintaining elevated margins despite inflationary pressures on input costs, underscoring the resilience of its centered on patient loyalty and limited in intimate care markets. Net profit margins have stabilized around 14-15% in recent periods, supporting strong returns on exceeding 24%.
Fiscal YearRevenue (DKK million)Organic Growth (%)EBIT Margin Before Special Items (%)
2022/2324,500828
2023/2427,0307-8 (estimated)27-28
This table highlights recent acceleration, with historical patterns showing episodic margin expansions tied to cost discipline post-acquisitions and R&D efficiencies. Overall, Coloplast's financial trajectory reflects causal drivers like demographic aging in developed markets and via proprietary pouching technologies, yielding predictable cash flows and growth averaging over 10% annually since the early .

Recent Results and Projections (Up to 2025)

In the first half of 2024/25 (October 2024 to March 2025), Coloplast reported organic revenue growth of 7% in constant currencies, with reported revenue increasing 6% to DKK 13,956 million, driven by strength in chronic care segments despite impacts from a in care. The EBIT margin before special items stood at 27%, reflecting operational efficiencies offset by recall-related costs and currency headwinds. For the third quarter (April to June 2025), reached 7%, with an EBIT margin of 28% before special items, though reported revenue grew only 1% in DKK terms due to unfavorable currency effects. Over the nine months to June 2025, cumulative was 7%, maintaining momentum in ostomy and continence care while faced headwinds from the aforementioned recall of certain SpeediCath products. Guidance for the full 2024/25 (ending 2025) projects organic growth of approximately 7% at constant exchange rates, revised downward from an initial 8-9% forecast following the recall impacts, with an EBIT margin before special items of 27-28%. This outlook assumes stable market conditions and no further major disruptions, with net expected at around 25% of and a near 23%. Coloplast's pre-close update in late 2025 reaffirmed these targets, signaling confidence in closing the year within guidance despite persistent volatility.

Achievements in Profitability and Shareholder Value

Coloplast has maintained robust profitability, characterized by consistently high operating margins and returns on equity. In fiscal year 2023/24, the company reported an EBIT margin before special items of 27%, supported by 8% organic revenue growth at constant exchange rates and a 6% increase in EBIT before special items to DKK 7,286 million. Return on equity reached 31% for the period, reflecting efficient capital utilization despite dilutive effects from acquisitions like Kerecis, while return on invested capital after tax stood at 15%. Historically, Coloplast's ROE has averaged around 49% over the past decade, with a median of 58% across 13 years, underscoring sustained high profitability relative to medtech peers. In the first nine months of fiscal 2024/25, EBIT margins held at 27-28%, with organic growth of 7% in Q3, demonstrating resilience amid currency headwinds and operational investments. The company's focus on is evident in its progressive and total return orientation. For fiscal 2023/24, Coloplast proposed a of DKK 22.00 per share, a 5% increase from DKK 21.00 the prior year, resulting in total payouts of DKK 4,720 million and a payout of 98-99%, aligned with a target range of 60-80% through dividends and potential buybacks. Dividends have grown at an average annual rate of over 5% in the past five years, with yields typically ranging 2-3.6%, providing reliable income amid share price . Over longer horizons, total shareholder returns have compounded positively; for instance, from 2015 onward, including dividends, returns exceeded 63%, blending capital appreciation and distributions. This approach prioritizes sustainable long-term value creation, as emphasized in , even as recent five-year TSR stood at around 58% through 2022, outperforming pure price returns due to dividend contributions.
Key Profitability Metrics (FY 2023/24)Value
EBIT Margin (before special items)27%
31%
8%
ROIC (after tax, before special items)15%

Controversies and Regulatory Challenges

Transvaginal Surgical Mesh Litigation

Coloplast Corporation developed and marketed transvaginal products, including the Novasilk and Supris devices, intended for the treatment of (POP) and stress urinary incontinence (SUI) by reinforcing weakened vaginal walls or supporting the urethra and bladder neck. These polypropylene-based implants faced allegations in lawsuits that they were defectively designed, incompatible with human tissue, and prone to causing complications such as mesh erosion, , , infection, and organ due to inflammatory reactions and degradation over time. The company's products were part of a broader multidistrict litigation (MDL) in the U.S. District Court for the Southern District of , where Coloplast encountered fewer claims than major competitors like or . In early 2014, Coloplast agreed to a global settlement resolving approximately 400 individual lawsuits for nearly $16 million, averaging about $40,000 per plaintiff, without admitting liability; this covered claims primarily related to POP repair meshes. Some cases proceeded to , including ongoing litigation over slings into 2025, with plaintiff firms reporting acceptance of revision or removal claims alleging persistent injuries. A notable case was Redding v. Coloplast Corp., filed on September 18, 2014, in Florida state court, where plaintiff Virginia Redding claimed injuries from Novasilk POP mesh and Supris SUI sling implants, including pelvic pain and erosion requiring revision surgeries. A jury awarded Redding $2.5 million in compensatory damages in 2022, finding defective design despite Coloplast's statute-of-limitations defense; the trial court denied post-trial relief, and the Eleventh Circuit Court of Appeals upheld the verdict on June 20, 2024, rejecting arguments that the claim accrued outside Florida's four-year limit. Regulatory scrutiny intensified following the U.S. Food and Drug Administration's (FDA) 2011 safety communication highlighting serious adverse events from transvaginal POP meshes across manufacturers, prompting Coloplast's mandated postmarket surveillance study under Section 522. The study's 36-month results, published in December 2022, indicated comparable effectiveness to native tissue repair for anterior-apical and total vaginal but elevated risks of mesh-specific complications like . Consequently, on April 16, 2019, the FDA ordered Coloplast and to cease U.S. sales and distribution of their POP transvaginal mesh devices, deeming the benefit-risk profile unfavorable, though mid-urethral slings for remained permissible.

Product Recalls and Safety Incidents

In January 2025, Coloplast initiated a Class 2 recall for Folysil Foley catheters (reference numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116), affecting approximately 22,000 units distributed in the United States, due to a potential detected during at the company's facility. The issue stemmed from possible risks in the production process, prompting an urgent voluntary recall notification sent via next-day air to consignees, with instructions to and return affected products; no adverse events were reported in connection with this recall. Earlier, in December 2024, Coloplast issued a voluntary recall for certain and endourology products, including Foley and prostatic catheters, following detection of a sterility barrier breach in packaging pouches during routine testing. This action, coordinated internationally including with , involved field safety notices urging cessation of use and return of specified lots, as microbial testing confirmed no impact on product sterility but highlighted packaging vulnerability; the recall was precautionary, with no confirmed patient harms. Similarly, in 2024, a Class 2 recall targeted ureteral dilators due to potential packaging integrity issues, notified via first-class mail to affected distributors. Historical incidents include a 2019 recall of T-distal ureteral stents for sterility concerns related to packaging defects, affecting units shipped between specific dates, with Coloplast confirming no evidence of compromised sterility upon investigation but proceeding voluntarily to mitigate risks. In 2011, SpeediCath intermittent catheters and related sets were recalled due to inclusion of iodine-based prep pads potentially unsuitable for latex-sensitive users, classified as Class 2 by the FDA. A Class 3 recall of InterDry Ag wound sheets in prior years addressed insufficient silver content in one lot, failing product specifications but without reported clinical impacts. These events reflect recurring themes of manufacturing and packaging quality controls, predominantly resolved through proactive voluntary actions without widespread adverse outcomes.

References

  1. [1]
    Mission and story
    ### Summary of Coloplast (https://www.coloplast.com/about-us/mission-and-story/)
  2. [2]
    Coloplast | Company Overview & News - Forbes
    Founded: 1957 ; Headquarters: Humlebæk ; Country/Territory: Denmark ; Chief Executive Officer: Lars Rasmussen ; Employees: 14,500 ...
  3. [3]
    Coloplast A/S - Full-Year Financial Results 2023/24 - Yahoo Finance
    Nov 4, 2024 · Reported revenue in DKK grew 10% to DKK 27,030 million. Organic growth rates by business area: Ostomy Care 7%, Continence Care 8%, Voice and ...
  4. [4]
  5. [5]
    Coloplast - History, Acquisitions, and Legal Troubles - Drugwatch.com
    Coloplast continues to grow through innovation, even as it confronts some legal problems in the U.S. Coloplast's reported revenue in 2021 was $2.8 billion. “ ...Missing: key achievements controversies
  6. [6]
    Coloplast Settles 400 Pelvic Mesh Cases for $16 Million
    Coloplast Corporation has settled an estimated 400 transvaginal mesh lawsuits for $16 million, allotting approximately $20,000 per plaintiff, according to ...Missing: facts achievements controversies
  7. [7]
    $$2.5 Million Judgment for Defective Mesh Implant Stands
    The Eleventh Circuit Court of Appeals affirmed a $2.5 million judgment in favor of the plaintiff, Virginia Redding, in a lawsuit against Coloplast Corporation.
  8. [8]
    Transvaginal Mesh Lawsuits: Lawsuit Updates & Top Lawyers
    The Eleventh Circuit Court of Appeals upheld a win this month for a woman who claimed that the Coloplast vaginal mesh implanted in her body was defective.Litigation Updates · Why People Sued · Lawsuit Allegations · Finding a Lawyer
  9. [9]
  10. [10]
  11. [11]
    Denmark-Based Medical Technology Group Coloplast - S&P Global
    Jun 4, 2024 · Coloplast has expanded its market position in all categories and continues to lead the European ostomy care (holding 40% of the market share) ...
  12. [12]
    Where is Coloplast Located? HQ, Global Offices & Company Insights
    Location: Coloplast has a strong global presence, with products sold in over 140 countries. · Street Address: Holtedam 1 · City: Humlebæk · State/Province: N/A ...
  13. [13]
    Coloplast: Ten Years of Global Operations - IESE Publishing
    In 2001, Coloplast conducted all its production in-house in three production facilities in Denmark. Ten years later, the company had relocated almost 90 per ...
  14. [14]
    Coloplast Still Pricey Even As A High-Quality Med-Tech Growth Name
    Jan 9, 2025 · While Coloplast's share in the U.S. has roughly doubled over the last decade, 20% share is still about half of Coloplast's global share, and ...
  15. [15]
    Coloplast A/S - Interim Financial Report, 9M 2024/25 - BioSpace
    Aug 19, 2025 · Coloplast delivered organic growth of 7% and an EBIT margin1 of 28% in Q3. Reported revenue in DKK grew 1% with negative impact from currencies ...Missing: operations position
  16. [16]
    None
    Below is a merged summary of the business segments and revenue breakdown for Coloplast FY 2023/24, consolidating all provided information into a single, comprehensive response. To maximize detail and clarity, I’ve organized the data into tables where appropriate (in CSV format for dense representation) and supplemented with narrative text for additional context. All figures are in DKK millions unless otherwise stated, and I’ve reconciled discrepancies by prioritizing the most consistent and detailed data across the segments.
  17. [17]
  18. [18]
    The unlikely inventor and the reluctant manufacturer - Coloplast's ...
    Dec 21, 2023 · In 1954, Elise Sørensen, a home-care nurse, met with the plastic-packaging manufacturer Aage Louis-Hansen to discuss a new idea she had ...
  19. [19]
    Coloplast - Companies History
    Apr 19, 2024 · Coloplast was founded in 1957, but the idea started in 1954 with a nurse who created an ostomy bag with an adhesive ring.Missing: milestones 1980
  20. [20]
    What is Brief History of Coloplast Company? - PESTEL Analysis
    Oct 6, 2025 · This innovation marked the official founding of Coloplast in Denmark on September 4, 1957. The company's initial business model focused on ...
  21. [21]
  22. [22]
  23. [23]
  24. [24]
  25. [25]
    Coloplast Corporation Acquires Mpathy Medical and Strengthens ...
    Oct 29, 2010 · Coloplast Corporation Acquires Mpathy Medical and Strengthens the Company's Position Within Female Pelvic Health For At Least $30 Million.
  26. [26]
    Coloplast acquires Comfort Medical - GlobeNewswire
    Nov 30, 2016 · Coloplast acquires Comfort Medical, a US direct-to-consumer nationwide dealer of catheters and ostomy supplies, for USD 160m.
  27. [27]
    Coloplast acquisition of Nine Continents Medical - Davis Polk
    Nov 3, 2020 · Davis Polk advised Coloplast on its acquisition of Nine Continents Medical, an early stage company pioneering an implantable tibial nerve ...<|separator|>
  28. [28]
    Coloplast announces agreement to acquire Kerecis and raises long ...
    Coloplast has signed an agreement to acquire Kerecis, an innovative, fast-growing company in the biologics wound care segment, for up to USD 1.3 billion.
  29. [29]
    Coloplast launches male catheter designed to reduce the risk of ...
    Feb 2, 2023 · The launch of Luja begins this month, February, in Denmark and Finland, and the product is expected to be available across Coloplast's key ...
  30. [30]
    Coloplast expands its Luja™ portfolio with next generation
    May 14, 2024 · Luja with Micro-hole Zone Technology for female users will launch across all Coloplast's key markets over the next 12 months, starting in ...
  31. [31]
    Coloplast A/S - Announcement no. 07/2021 – Annual Report 2020 ...
    Nov 1, 2021 · Financial highlights for the year 2020/21. Coloplast delivered 7% organic growth for the full year. Reported revenue in DKK was up by 5% to ...Missing: strategic 2010s 2020s
  32. [32]
    None
    ### Summary of Coloplast’s Impact4 Strategy
  33. [33]
    Healthcare – Still a compelling long-term opportunity - Walter Scott
    Jul 18, 2025 · Coloplast has experienced a difficult 2025 year to date, due to slightly weaker-than-expected results, a full-year guidance downgrade, and the ...Missing: milestones developments
  34. [34]
    Coloplast A/S - Announcement no. 05/2025 - Yahoo Finance
    Aug 18, 2025 · During the current strategy period, the Coloplast Group has expanded with the addition of Atos Medical and Kerecis. Effective immediately, the ...
  35. [35]
  36. [36]
  37. [37]
    SenSura® Mio 1-Piece Drainable Pouch - Coloplast
    Free delivery over $80SenSura Mio is a range of ostomy products that fits individual body shapes due to the elastic adhesive.
  38. [38]
    Innovation in ostomy care - Coloplast
    At Coloplast, ostomy has been our commitment since 1957 when nurse Elise Sørensen invented the first ostomy bag for her sister with colon cancer.Missing: early | Show results with:early
  39. [39]
    Coloplast strengthens ostomy care portfolio with three significant ...
    May 6, 2024 · SenSura Mio in black developed to provide more product choice for people living with a stoma. The company has received reimbursement ...
  40. [40]
    Brava® Protective Sheet - Free Samples - Coloplast
    Rating 4.8 322 · Free delivery over $80The Brava Protective Sheet is a skin-friendly product to be used under the ostomy barrier. It absorbs moisture and thereby minimizes the risk of maceration ...
  41. [41]
    Alterna®- Secure and skin-friendly ostomy appliances
    Security. • Adheres securely to the skin around the stoma, yet is painless to remove. • Resistant to erosion, which protects the skin against irritation.<|control11|><|separator|>
  42. [42]
    Ostomy Care Market Size & Future Outlook 2025-2030
    Jun 18, 2025 · The ostomy care market size reached USD 3.47 billion in 2025 and is on track to reach USD 4.30 billion by 2030, reflecting a steady 4.42% CAGR.
  43. [43]
    Coloplast A/S - Interim Financial Report, 9M 2024/25 - GlobeNewswire
    Aug 19, 2025 · Coloplast delivered organic growth of 7% and an EBIT margin1 of 28% in Q3. Reported revenue in DKK grew 1% with negative impact from currencies ...
  44. [44]
    Continence Care
    ### Summary of Coloplast Continence Care Solutions
  45. [45]
    Interventional Urology
    ### Summary of Coloplast's Interventional Urology Portfolio
  46. [46]
    Coloplast Has Signed An Offer To Acquire Mentor Corporation's ...
    Mar 28, 2006 · With the contemplated acquisition Coloplast will achieve a broader portfolio in the growing catheter market and will become a leading global ...
  47. [47]
    SpeediCath Standard - Ostomy Care programs
    Intermittent catheter design took a large step forward when Coloplast created SpeediCath® - the first instantly ready to use intermittent catheter.
  48. [48]
    Triple Action Coating Technology - Coloplast
    SpeediCath with Triple Action Coating Technology stays bonded, stays smooth, and stays hydrated for protection of the urethra. View products and order a ...
  49. [49]
  50. [50]
    Wound Care Solutions - Coloplast US
    Management of non-infected wounds. Our wound care brands Biatain ®, Comfeel ®, Physiotulle ® and Purilon ® are all highly performing solutions for wound ...
  51. [51]
  52. [52]
    Wound Care - Coloplast Professional
    Comfeel® Plus Transparent – promotes moist wound healing by sealing and protecting of the wound. Excellent support for closure of wounds. Flexibility to dress ...
  53. [53]
    Triad® Wound Dressing | Wound Care - Coloplast Professional
    Triad is a sterile coating that can be applied directly onto the wound or periwound skin. It can be applied anywhere on the body and adheres to wet skin, ...
  54. [54]
    Brava® Skin Barrier Spray Buy now - Coloplast
    In stock Free delivery over $80The Brava Skin Barrier is sting-free and reduces skin problems associated with output and adhesives. It leaves a thin breathable film on the skin.
  55. [55]
    HEAL Program - Coloplast
    The HEAL programme includes a number of medical educational courses that cover a variety of wound care topics.
  56. [56]
    Coloplast Interventional Urology Physician Resources - Coloplast
    Here, you'll find a broad portfolio of products, resources and support materials, education and training resources, and patient educational materials.Testicular Replacement · Pelvic Floor Reconstruction · Male Continence · Products
  57. [57]
    Titan® Penile Implants - Coloplast Interventional Urology
    Titan IPP provides performance in both the operating room and the bedroom. Titan IPP is designed to overcome complications, address patient satisfaction.
  58. [58]
    Titan® Penile Implant - Take Back Control - Coloplast Men's Health
    The Titan Inflatable Penile Prosthesis is a surgically implanted mechanical penile implant intended for the treatment of erectile dysfunction in men. The Titan ...
  59. [59]
    Erectile Dysfunction (E.D) - Coloplast US
    Two types of implant options are available. Coloplast offers two types of implant options, the Genesis ® and the Titan ® OTR penile implants. Both give men ...
  60. [60]
    Prosthetic Urology | Coloplast IU Physician Resources
    Innovative products that help you provide highly effective and satisfying options for men with erectile dysfunction. Erectile restoration. Innovative products ...
  61. [61]
  62. [62]
    Endourology Information - Coloplast US
    Coloplast offers a wide range of disposable products to support endourologic and percutaneous procedures, including Dormia ® stone extractors, ureteral stents, ...<|separator|>
  63. [63]
    Endourology | Coloplast IU
    Coloplast offers products to make your BPH procedures more efficient and improve your patients' quality of life. Learn more.
  64. [64]
    [PDF] Endourology - Coloplast Interventional Urology
    Coloplast has a long history of providing quality, innovative products to support endourologists and their patients. Our story began in 1893.
  65. [65]
    Coloplast Completes Acquisition Of Mentor Corporation's Urology ...
    Jun 5, 2006 · In March of 2006, Coloplast secured an agreement with Mentor to acquire its urology business. "With customers in mind, we have developed a ...
  66. [66]
  67. [67]
    Coloplast acquires Comfort Medical for $160m - MassDevice
    Dec 1, 2016 · Coloplast (CPH:COLO B) said today it inked a definitive agreement to purchase urological device supplier Comfort Medical for $160 million.
  68. [68]
    Coloplast acquires tibial nerve stimulation developer Nine Continents
    Nov 4, 2020 · Danish medical device company Coloplast has acquired implantable tibial nerve stimulation (ITNS) treatment developer Nine Continents Medical for $145m.
  69. [69]
    Coloplast completes the acquisition of Atos Medical - Yahoo Finance
    Jan 31, 2022 · Coloplast has now completed the acquisition of Atos Medical announced on November 8, 2021 after receiving approval from relevant authorities.
  70. [70]
  71. [71]
    Coloplast buys fish skin woundcare firm for up to $1.3 billion | Reuters
    Jul 7, 2023 · Coloplast has agreed to buy Iceland-based Kerecis, a biologic wound care firm that uses fish skin to develop tissue-transplant products, ...
  72. [72]
  73. [73]
    Coloplast announces new financial ambition towards 2030
    Sep 1, 2025 · In relation to the launch of Coloplast's new 5-year strategy, Impact4, the company announces a new financial ambition with organic revenue ...
  74. [74]
    Coloplast (OTCPK:CLPB.Y) - Earnings & Revenue Performance
    Revenues have been growing at an average rate of 9.6% per year. Coloplast's return on equity is 24.8%, and it has net margins of 14.6%.
  75. [75]
  76. [76]
    Coloplast A/S - Annual Report 2022/23 ... - Yahoo Finance
    Nov 8, 2023 · Coloplast A/S. FY 2022/23 organic growth of 8% and 28% EBIT margin1). Reported revenue in DKK grew 9% to DKK 24,500 million.
  77. [77]
    Coloplast A/S (COLO-B.CO) Income Statement - Yahoo Finance
    Total Revenue. 27,867,000. 27,030,000 ; Cost of Revenue. 9,044,000. 8,761,000 ; Gross Profit. 18,823,000. 18,269,000 ; Operating Expense. 11,302,000. 10,983,000.Missing: performance | Show results with:performance
  78. [78]
    Coloplast A/S (COLO-B.CO) Dividends - Digrin
    Average dividend growth rate for stock Coloplast A/S (COLO-B.CO) for past three years is 5.27%. 01/01/2000 01/01/2020 ...
  79. [79]
    Coloplast A/S - Announcement no. 04/2025 - Interim - GlobeNewswire
    May 6, 2025 · Interim financial results, H1 2024/25. 1 October 2024 - 31 March 2025. Coloplast delivered 6% organic growth in Q2, impacted by the product ...
  80. [80]
    [PDF] 9M 2024/25 Earnings release
    Aug 19, 2025 · Coloplast delivered organic growth of 7% and an EBIT margin1 of 28% in Q3. Reported revenue in DKK grew 1% with negative.
  81. [81]
    Coloplast A/S - Interim Financial Report, 9M 2024/25 - Inderes
    Aug 19, 2025 · FY 2024/25 guidance is unchanged with organic growth of around 7% and an EBIT margin before special items of 27-28%. Organic growth now includes ...
  82. [82]
  83. [83]
    CLPBY (Coloplast AS) ROE % : 19.92% (As of Jun. 2025) - GuruFocus
    Rating 3.5 · Review by GuruFocusCLPBY (Coloplast AS) ROE % as of today (September 27, 2025) is 19.92%. ROE % explanation, calculation, historical data and more.Missing: achievements | Show results with:achievements
  84. [84]
    Coloplast A/S - Interim Financial Report, 9M 2024/25 - Yahoo Finance
    Aug 19, 2025 · Coloplast delivered organic growth of 7% and an EBIT margin1 of 28% in Q3. Reported revenue in DKK grew 1% with negative impact from currencies ...
  85. [85]
    Coloplast AS (CLPBF) Q2 2025 Earnings Call Highlights: Navigating ...
    May 7, 2025 · EBIT Margin Before Special Items: 27% in Q2, revised annual expectation to 27%-28%. Return on Invested Capital: 15%, on par with last year.
  86. [86]
    Coloplast (COLOb) Stock Dividend History & Date 2025
    Coloplast's annualized dividend payout is 22.00. What Is The Growth Rate Of Coloplast's Dividends? Coloplast has a 5-year dividend growth rate of +5.29%.
  87. [87]
    Current Coloplast-B dividend in October 2025 - DividendStocks.Cash
    Including dividends, the total return of Coloplast-B increases to 63.2% and the annual yield grows from 2.4% to 5%. The total return is composed of 42% capital ...
  88. [88]
    The total return for Coloplast (CPH:COLO B) investors has risen ...
    Sep 29, 2022 · We note that for Coloplast the TSR over the last 5 years was 58%, which is better than the share price return mentioned above. This is largely ...
  89. [89]
    Transvaginal Mesh Lawsuits 2025
    $$2.5 Million Mesh Verdict​​ $2.5 million was awarded to Virginia Redding against Coloplast for injuries she suffered from her Novasilk pelvic mesh and Supris ...Missing: outcome | Show results with:outcome
  90. [90]
    Wagstaff & Cartmell $2.5 Million Judgment in Pelvic Mesh Trial ...
    In 2022, the jury ruled in her favor, awarding her $2.5 million and rejecting Coloplast's argument that the claim was time-barred. Coloplast's appeal, which ...
  91. [91]
    Coloplast Mesh | The Cochran Firm Washington DC
    The lawsuits allege that the polopropylene mesh used to make the transvaginal mesh products is incompatible with human tissue and causes inflammatory reactions, ...
  92. [92]
    Coloplast Class Action Lawsuit (Transvaginal Mesh Products and ...
    Serious complications associated with mesh products include: vaginal and urethral erosion, pain including dyspareunia, infection as well as perforations of ...Missing: litigation | Show results with:litigation
  93. [93]
    Transvaginal Mesh Lawsuit: October 2025 Settlements & Verdicts
    Coloplast faced the second-fewest lawsuits in the West Virginia MDL. The company announced it would settle about 400 mesh lawsuits for $16 million in January ...
  94. [94]
    Transvaginal Mesh Litigation - Seeger Weiss LLP
    Coloplast Corp.: In 2014, Coloplast settled approximately 400 transvaginal mesh lawsuits for nearly $16 million. C.R. Bard, Inc.: After losing both federal ...Case Details · Our Role · Transvaginal Mesh Implants...
  95. [95]
    Transvaginal Mesh Lawsuit - Pelvic Mesh - Bladder Sling - Impact Law
    COLOPLAST. In March 2104, Coloplast agreed to pay about $16 million to settle roughly 400 individual lawsuits surrounding their transvaginal mesh products.<|separator|>
  96. [96]
    Coloplast Bladder Mesh Lawsuit 2025
    Coloplast bladder mesh lawsuits are filed for injured women in 2025 and we are accepting sling and mesh removal/revision cases.
  97. [97]
    [PDF] United States Court of Appeals
    Jun 20, 2024 · On. September 18, 2014, Virginia Redding sued Coloplast Corporation, alleging that vaginal mesh devices inserted inside her body were.
  98. [98]
    Redding v. Coloplast Corp., No. 22-13218 (11th Cir. 2024)
    Jun 20, 2024 · Redding alleged that vaginal mesh devices inserted inside her body were defectively designed. Coloplast argued that Redding's suit was time- ...Missing: outcome | Show results with:outcome
  99. [99]
    FDA's Activities: Urogynecologic Surgical Mesh
    Apr 11, 2024 · Therefore, the FDA maintains that these devices do not have a favorable benefit-risk profile. With the completion of the Coloplast 522 study, ...
  100. [100]
    Final Results for Study of Transvaginal Mesh for Pelvic Organ ...
    Dec 6, 2022 · A 36-month follow-up study showed that Coloplast transvaginal mesh for pelvic organ prolapse repair had similar effectiveness and safety
  101. [101]
    FDA orders Boston Scientific, Coloplast to stop selling surgical mesh
    Apr 16, 2019 · The Food and Drug Administration on Tuesday ordered Boston Scientific and Coloplast to stop selling surgical mesh used for some pelvic operations.Missing: discontinued | Show results with:discontinued
  102. [102]
    Transvaginal Mesh Recalls & Discontinued Products - Drugwatch.com
    Boston Scientific and Coloplast were unable to provide adequate data to the FDA, and the agency ordered them to stop selling their products on April 16, 2019.
  103. [103]
    Coloplast told by FDA to keep transvaginal mesh off market after 36 ...
    Oct 18, 2022 · The mesh provides similar effectiveness and safety outcomes to native tissue repair but also comes with additional risks, ...
  104. [104]
    Class 2 Device Recall Folysil silicone catheters
    Jan 10, 2025 · Class 2 Device Recall Folysil silicone catheters ; A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
  105. [105]
    Coloplast Catheters - Canada.ca - Recalls and safety alerts
    Dec 30, 2024 · This recall is due to breach in sterility barrier (packaging pouch) ... Coloplast Catheters. Brand(s). Coloplast A/S. Last updated. 2024-12-30 ...
  106. [106]
    Field Safety Notice Coloplast Urology and Endourology Products
    Important Customer Notice Status New Type Product Recall · 16 December 2024, 4.29pm · 2768 Coloplast Field Safety Notice 16 · 2768 Coloplast Product Listing ...
  107. [107]
    Class 2 Device Recall Ureteral Dilator
    Apr 2, 2024 · Coloplast issued an URGENT MEDICAL DEVICE VOLUNTARY RECALL notice to its consignees on 03/11/2024 via USPS first class mail. The notice ...
  108. [108]
    Coloplast recalls stents due to package sterility issue - MassDevice
    Nov 27, 2019 · Coloplast recalls stents due to package sterility issue. November 27 ... The company said it issued the recall because there may be some ...
  109. [109]
    Class 2 Device Recall SpeediCath , SpeediCath with Accessories
    for Recall, Coloplast has initiated a recall on SpeediCath with Insertion Supplies and SureCath Set with Insertion Supplies because they contain Iodine prep ...
  110. [110]
    Class 3 Device Recall InterDry Ag - accessdata.fda.gov
    507-345-6200 · Coloplast determined that a portion of one lot of InterDry" Ag Lot number 1789435, did not meet the product specification for silver content.