Integra LifeSciences

History

2023: Recall of all products - it causes fever

On May 22, 2023, the US Securities and Exchange Commission (SEC) announced that the American developer and manufacturer of medical devices Integra LifeSciences is forced to withdraw all products. It turned out that the products can provoke postoperative fever, threatening the health of patients.

We are talking about products that were manufactured at Integra LifeSciences in Boston (Massachusetts). Low-quality products were delivered from March 1, 2018 to May 22, 2023. An internal investigation showed that violations in the production process could lead to an increased content of endotoxins - bacterial toxic substances. And this can cause a negative immune response in patients.

Integra SurgiMend Collagen Matrix

The official notice on the SEC website says there are no specific complaints about Integra LifeSciences' low-quality products. However, the company, in line with "its commitment to patient safety," decided to initiate a voluntary product recall. In addition, the company in Boston temporarily stopped working: it plans to introduce additional quality control measures.

It is known that the recall primarily concerns tissue products, such as SurgiMend collagen matrix, which accounts for 5% of the company's revenue. According to the forecasts of Integra LifeSciences, the enterprise will receive losses due to impairment in the amount of $22 million: these are, in particular, expenses related to the write-off of inventories of low-quality products, which, in addition to SurgiMend, include PriMatrix, Revise and TissueMend. The company's revenue at the end of 2023 may be $60 million less than expected. BTIG analysts say the recall raises "big questions" about Integra LifeSciences' management.^[1]

2022: CereLink monitors withdrawn due to marriage

On August 18, 2022, Integra LifeSciences announced the start of a voluntary global recall of all CereLink intracranial pressure monitors after receiving customer reports that device readings were out of range. Read more here.

2020: Smith & Nephew bought Integra LifeSciences for $240m

At the end of September 2020, Smith & Nephew acquired Integra LifeSciences, an orthopedic research company, for $240 million. As a result of the transaction, Smith & Nephew gained control of the Titan Reverse Shoulder System portfolio of products for arthroplasty of the shoulder joint, which brought Integra LifeSciences income of $90 million in 2019.

In addition, Smith & Nephew has received a number of other devices, implants and tools used for arthroplasty of the shoulder joint and reconstruction of the bones of the arm, wrist, elbow, foot and ankle. Smith & Nephew considers them as an addition to the existing range of orthopedic products, the sales of which in 2019 brought the company over $2.2 billion.

Smith & Nephew acquires orthopaedic maker

Integra LifeSciences CEO Peter Arduini sees the sale of assets as an opportunity to draw public attention to the problems of neurosurgery, surgical instruments and regenerative medicine. Smith & Nephew, in turn, hopes to take advantage of the established commercial ties of Integra LifeSciences in the USA, Canada and Europe. Under the leadership of Smith & Nephew will be transferred 300 employees of Integra LifeSciences, who work in Texas and at the site for the training of surgeons in France.

In the near future, the acquired assets are unlikely to bring significant income to Smith & Nephew, since sales of orthopedic devices have almost halved amid the pandemic. The reason was the temporary refusal of planned operations, including orthopedic. However, Smith & Nephew hopes to gain a foothold in this sector by attracting sales representatives and distributors Integra LifeSciences to successfully compete in the future with companies such as Zimmer Biomet and Wright Medical.^[2]

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