Abstract

Mesh implants intended to treat patients with pelvic organ prolapse (POP) can be implanted via two surgical approaches: via the abdomen (transabdominal) or via the vagina (transvaginal).

The Health and Youth Care Inspectorate requested RIVM to assess the technical documentation of mesh implants intended to treat patients with POP. First, RIVM investigated which mesh implants were used by physicians. Nine types of mesh implants used by physicians in the Netherlands in 2018 were assessed. Four of these are intended for implantation via the vagina and five for implantation via the abdomen. The nine mesh implants are produced by six different manufacturers.

RIVM has identified major or minor shortcomings in multiple parts of the technical documentation of all assessed products. An example of a major shortcoming is that the safety and performance are not adequately substantiated with data on the use of the product in humans. A minor shortcoming is for example the lack of an adequate description of the surgical procedure in the instructions for use in cases where it is indicated that physicians have to be trained to perform this type of surgery.

It is not clear whether the identified shortcomings could potentially damage a patient’s health. Shortcomings in the technical documentation do not necessarily imply that the actual product is of insufficient quality. However, the safety and performance of the products have not been substantiated properly due to the shortcomings in the technical documentation. The regulatory system requires that manufacturers carefully investigate and resolve the shortcomings in their technical documentation. Manufacturers have indicated that they are improving the technical documentation based on the results of the assessment by RIVM. Some manufacturers have reported that they have been reaudited by their notified bodies and that their improved technical documentation is now compliant with European regulatory requirements. These audits took place after the RIVM assessment was completed.

Starting in May 2021, new European regulations for medical devices will apply. This means manufacturers will have to comply with additional and more strict requirements, also for the technical documentation.
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The texts below are reactions from stakeholders (legal entities such as companies or organisations, or private individuals) in response to the RIVM report. These reactions are not official opinions held by RIVM, nor information originating from RIVM. The content of these reactions is entirely at each stakeholder’s own expense and risk.
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Reaction Ethicon -Johnson and Johnson

The safety of those who use Ethicon’s products is our highest priority. Transabdominal mesh implants like our GYNECARE GYNEMESH PS and ARTISYN products have been used for decades and are well-regarded as the gold standard for treating vaginal vault prolapse. Our products are safe and effective and are backed by years of clinical research and data.

Ethicon values transparency and dialogue with administrative authorities and is committed to continuous improvement of our technical documentation in light of evolving regulatory standards. We disagree with the report’s conclusions. To be clear, the report concerns a review of older product documentation and is not a product safety assessment regarding GYNECARE GYNEMESH PS and ARTISYN. Transabdominal prolapse meshes are not subject to any restrictions of use in the Netherlands and remain an important option for doctors and patients.

Recently, both the Inspectie Gezondheidszorg en Jeugd (IGJ) and Dutch gynaecological society (NVOG) have stated that few complications/complaints have been seen with transabdominal prolapse mesh implants. We stand behind our products which are supported with clinical data and are a safe and effective treatment option for upper vaginal prolapse.
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Reaction Promedon

As leader in pelvic floor solutions for women, Promedon remains steadfast in its commitment to helping our patients live better and healthier lives.

Although we believe scientific collaboration helps achieve this objective, we are highly disappointed with how the RIVM has acted in regard to this report. In our view, most conclusions reached on Promedon's "Calistar S" product are incorrect and not based on the legal standard of review for technical documentation for a medical device. The RIVM has also failed to include documentation and information generally dated after 2018 (although we requested this). Therefore, this report fails to provide an accurate, current, objective status of the technical documentation related to our "Calistar S" product.

Given our concerns with the inappropiate methodology used we remain engaged in legal action with the RIVM at the time of publication. Notwithstanding the foregoing, this Report and the RIVM's underlying evaluation have no implications regarding regulatory approval of the "Calistar S" product, as confirmed by the RIVM itself in the report.

We are completely confident regarding the benefits and safety of our treatments for POP and shall continue to market products with the same outstanding commitment to quality as ever.