The criticism is raining down on danish medtech group Coloplast these days, and the company has allocated DKK 5.25 billion (approximately USD 797 million) for reaching settlement with thousands of women who suffered harm from Coloplast's mesh nets.
A transvaginal mesh net is a medical device used for treating women with pelvic organ prolapse and stress urinary incontinence. However, the devices have caused serious damage like pains, strictures and smelly vaginal discharge.
The Coloplast products have been marketed under the names Novasilk and Supris and implanted in patients' bodies without previous clinical in-human trials to document the safety and efficiency of the devices.
Our products are effective and safe to use when they are implanted by competent surgeons in the right patients.
Coloplats's synthetic mesh nets are not used in Denmark, but the company still sells its products to women in other countries , for instance, the US.
And according to CEO in Coloplast, Lars Rasmussen, patients can feel safe when buying the products. To him, it goes without saying for Coloplast that the company's products meet all requirements and rules.
"Before a product is marketed it must be approved by the authorities, and Coloplast has provided all the necessary data for the respective national regulatory authorities," he writes to MedWatch.
Nevertheless, at least 7000 American women have sued Coloplast after suffering injuries from the mesh net, and so far the Danish company has paid DKK 4.7 billion (around USD 713.5 million) to settle with the women.
Sales of devices for urological and abdominal operations makes up about 11 percent of Coloplast's total earnings.
Coloplast has previously denied that the settlements are a confession of the company's guilt. Instead, the company described the compensations as the "most cost-effective solution" compared to eventual trials.
Rasmussen declined to give an interview or answer specific questions from MedWatch.
However, he stresses that Coloplast cooperates closely with the US Food and Drug Agency, FDA, to optimize the safety of the company's products.
"During the past five years, we have been part of two comprehensive clinical trials in the US, and we collaborated with FDA and internationally recognized doctors and surgeons," writes the CEO.
"The studies evaluate the safety when using our products over time as compared to the strict rules of the area. FDA will publish the study results in 2019," he elaborates.
Rasmussen adds that Coloplast also invests significant sums in clinical evidence and training of surgeons.
"To ensure correct use of our products, we spend more than 3000 hours every year on trainings of surgeons on a global plan. Moreover, we continuously conduct clinical trials and collect clinical evidence throughout the life cycle of the product," he writes and adds:
"Our products are effective and safe to use when they are implanted by competent surgeons in the right patients."
Not for everyone
During the past years, FDA has increased the demands for pelvic organ prolapse implants. The products are now categorized as class III products - high-risk medical devices.
According to danish media Politiken, the mesh net market has shrunk as a consequence of the stiffened demands, and today there are only three products left on the market relative to the previous 131 products from 34 manufacturers.
Neither Coloplast nor FDA want to inform whether Coloplast is the manufacturer of one or more of the three remaining products. But according to Rasmussen, FDA still recognizes mesh nets as treatment of pelvic organ prolapse and stress urinary incontinence.
To ensure correct use of our products, we spend more than 3000 hours every year on trainings of surgeons on a global plan.
"And on its website, the American Urogynecologic Society (AUGS) calls transvaginal mesh nets a "first-class" treatment option for stress urinary incontinence," writes Rasmussen.
He admits the existence of non-surgical alternatives to the mesh implants but also stresses that the mesh nets Coloplast offers today provide an alternative for patients with pelvic organ prolapse and stress urinary incontinence.
"At the same time, it is important to mention that our mesh nets are not suitable for all patients with pelvic organ prolapse and stress urinary incontinence," adds the CEO.
Ready for stricter regulations
In April 2017, the EU countries adopted new regulations for medical devices that will apply in all of EU in 2020.
The aim is to enhance patient safety and secure access to new devices for the benefit of the patients.
With the new rules follow stricter demands for the clinical evaluations and documentation in connection with approval of medical devices, including high-risk products like implants.
Moreover, data about marketed medtech products in the EU will be collected in a central database called EUDAMED, and the product information will be accessible for manufacturers and authorities as well as the general public.
According to Rasmussen, Coloplast is well prepared for the new EU regulations.
"We acknowledge the new rules and will continue to comply with all existing requirements, just like we will continue to invest in clinical studies that ensure high-quality products for users all over the world," writes the CEO.
So far, Coloplast has settled all cases with the women who sued the company. As part of the settlement, the women had to sign a confidentiality clause that prevents them from telling their story.
English Edit: Ida Løjmand
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