Reactie: Johnson & Johnson

'STATEMENT:

First and foremost, we have always made patient safety a top priority.  We empathize with all women suffering from pelvic organ prolapse (POP), a condition that can be serious and debilitating, and we are always concerned when a patient experiences adverse medical events.

The use of implantable mesh to treat POP is backed by years of clinical research.

The PROLIFT mesh kits for POP previously marketed by Ethicon were the result of continuous research and development efforts that leveraged the expertise of pelvic floor surgeons, scientists, and engineers.  Both before and after the launch of PROLIFT, Ethicon consistently evaluated the product in clinical settings.  Those studies demonstrated that PROLIFT was efficacious and had a low rate of post-operative complications when used with appropriate patient selection and proper surgical techniques. Further, well over 100 independent studies, involving thousands of women, have corroborated PROLIFT’s safety and efficacy. The results from these studies have been subjected to rigorous review by experts and have been published in some of the most prestigious medical journals in the field.

All surgeries to treat POP have risks, regardless of whether surgical mesh is used. The risks unique to the use of PROLIFT were properly identified in Ethicon’s Instructions for Use and professional education materials, and were also widely known and discussed in scientific literature and at scientific meetings.

In June 2012, Ethicon reached a business decision to discontinue the global commercialization of some of our pelvic mesh products, including all transvaginal mesh devices used for the treatment of POP.  Our decision to discontinue these products was based on their commercial viability in light of changing market dynamics, and was not related to the safety or efficacy of the products.'