Fa.Johnson&Johnson stellt Vertrieb von Netzen ein


Es waren wirklich “breaking news” vergangene Woche, als der internationale Großkonzern Johnson und Johnson bekantgab,den Vertrieb von sogenannten synthetischen Netzen, welche zur operativen Korrekturen von sogenannten “Senkungszuständen” auch in vielen Abteilungen Österreichs zur Anwendung kamen, eingestellt hat.(s.u. Presseaussendung in engl.)

Die Einstellung erfolgte offensichtlich aufgrund von zahlreichen Komplikationen nach Anwendung derartiger Netze, welche oft erst spät nach Durchführung der Operation zustande kamen. Ob andere Firmen, welche ähnliche Netze auf den Markt bringen,ebenfalls diesen Schritt gehen werden, bleibt abzuwarten.

In a statement Tuesday, the company stressed that the move was not a recall, but was based on the products’ commercial viability “in light of changing market dynamics, and is not related to safety or efficacy.”

The announcement comes after years of controversy over the implants, which are used to treat incontinence caused by muscle weakening and a condition called pelvic organ prolapse, in which organs descend and press against the vaginal wall. The devices have been linked to serious injuries in women, including infections, pain and other complications. In 2008, the Food and Drug Administration warned that use of the implants was associated with complications but that the problems were rare. But between 2008 and 2010, the agency reported a fivefold increase in reports related to the use of the devices. In January, the F.D.A. ordered makers of the implants to study their risks in patients.

“This is very good news for women because it takes several products off the market that have harmed a lot of women,” said Diana Zuckerman, president of the National Research Center for Women and Families, a public health advocacy group. However, she said, “the bad news is that there are many other surgical meshes still on the market that are just as dangerous.”

Other device makers that also sell surgical mesh products include Boston Scientific, C. R. Bard and W. L. Gore & Associates. In a statement, a spokeswoman for Boston Scientific said the company believed that using such products “is and remains an important treatment option for patients.”

The four products Ethicon will discontinue are the Gynecare TVT Secur system, the Gynecare Prosima, the Gynecare Prolift and the Gynecare Prolift+M. Ethicon will stop selling the products over the next three to nine months, with a goal of ending sales worldwide by the first quarter of 2013. A spokesman for Ethicon declined to say how many women were implanted with the products

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