DECEMBER 29, 2011 ~ The Netherlands will begin a patient registry of synthetic gynecological mesh in early 2012 requiring gynecologists to report the growing number of complications emerging from use of the mesh. The U.S. has yet to establish post-surgery patient tracking to determine the actual number of adverse events. Investigative reporter, Ellen de Visser looked into the gr0wing problem in the Netherlands in this published report in the newspaper, de Volkskrant. The article has been translated with the help of the founders of www.meshedup.eu.
(BTW- Bekkenbodem means pelvic floor.)
I thank everyone involved for bringing this international issue to a U.S. audience and for permission to reprint from de Volkskrant.
Emke de Graaf and Isabella Mertens founders of MeshedUp
Emke from The Netherlands and Isabella from Belgium have been helping sufferers in The Netherlands and Belgium since the beginning of 2009. They have written an enormous amount of letters to newspapers, the government, doctors, the Dutch and the Belgian Health Inspection and all sorts of other organizations to bring awareness and try to stop mesh operations to be allowed in the Benelux. With help of Dutch and Belgian political parties they are trying to change The European Laws concerning medical devices. Recently they started their website www.meshedup.eu.
Article as it appeared in de Volkskrant The Netherlands 19 November 2011
The Dutch Health Inspection started an investigation after serious complaints from women who had prolapse surgery. During the operation the gynecologists used synthetic meshes that caused considerable complications.
The American Health service FDA recently warned for the use of meshes. In the United States of America hundreds of women have submitted claims. In The Netherlands each year 13 thousand women undergo surgery after having prolapse complaints. Since a few years sometimes meshes
are used that function as an additional support. The FDA note that the meshes provide a greater risk of complications because they can release partially or shrink. Pain, infection or incontinence may be the result. How many meshes were used in the Netherlands is unknown. According to some gynecologists the industry has used a lot of pressure during the introduction of the meshes. ‘If that’s true, the gynecologists took part of this’, is the reaction of Chief Executive Roelf van Run of Nefemed, the Organization of Manufacturers of Medical Devices in Holland. ‘Of course manufacturers want doctors to work with their products, but that should happen responsibly. In this matter doctors also play a role.’
Having a prolapse is already a disaster. But some women who got a mesh implanted to restrain the prolapse, get so many complications, this shouldn’t have been allowed.
She can‘t work anymore, is not able to cycle and even walking takes some effort. She is in constant pain, she is incontinent and sex has become impossible. Because prolonged sitting can cause problems, she brings along a bread board when she pays someone a visit. There is one advantage to this situation, she says cynically: “at least my husband doesn’t have to worry that I might cheat on him.”
Since Emke de Graaf (51) underwent a prolapse operation in the beginning of the year 2008, she feels she is not more than a shadow of the person she used to be. The gynecologist put her rectum - that had partly declined in the vagina, after the birth of her children - back in place, by using a sustaining synthetic mesh.
But what should have been the solution for her continuing problems, turned out to be the beginning of disability: the mesh was placed to tight and situated too high, so now the bowel could find itself a new way down, to an even more miserable spot.
“People usually don’t talk freely about poo-, pee- and sex problems,” she says blithely, and therefore it took time before she found fellow-sufferers on medical forums. But now, nearly four years later, she finally finds heed. After receiving serious complaints from a group of women, the Dutch Health Inspection commenced an investigation in cooperation with the British Health Inspection.
Along with a Belgian fellow sufferer, she established an advice and contact center that they have scornfully called ‘Meshed Up’ (www.meshedup.eu). She says: "I ended up at a sidetrack of my life. This is a misery that other women should be spared. "
Studies in a great number of trade papers do not give a positive image at all to the effect of the meshes. An American research was stopped halfway because too many women got complications.
The American FDA published a firm warning last summer after the Health Service went through all studies and put in order all the complaints of the women. The meshes turn out to lead to serious complications, and those complications are, so the FDA writes in bold letters, not rare and cause for concern. After implantation the mesh can partly come out again, it can shrink and scar tissue can arise around the affected spot.
The consequences can be ‘debilitating’ for some women, thus the FDA. Recovery operations are not always possible or don’t always provide a solution. Hundreds of American women have already submitted claims because they were not aware of the risks. And all that while, according to the FDA, it hasn’t been demonstrated that using meshes give better results than the conventional techniques.
In the Netherlands yearly 13,000 women have to undergo a prolapse operation. For a long time the surgeons used to hang up the descended organs (uterus, bladder or bowel) on to the supporting tissue of the pelvic floor. Six years ago the meshes were introduced as a solution for women who haven’t got any supporting tissue left and can use an extra prop. Numerous types of meshes of different manufacturers appeared on the market and, according to some gynecologists, a lot of pressure has been wielded.
Ellen Everhardt, gynecologist of the Dutch Medisch Spectrum Twente and former President of The Professional Association of Urogynecologists (NVOG), wrote a flaming article about the issue in the Dutch magazine for Obstetrics and Gynecology last year. The initial caution the physicians pursued in using meshes in the beginning -only in women with recurring prolapses, and preferably related to research matters- was left quite soon, stimulated by the manufacturers.
The complications of these surgical operations stay underexposed, according to Ellen Everhardt because “the introduction of new meshes moves about faster than the publication of articles on mesh-complications.”
“What do the profession and the industry do if claims come from the patients”, she questions herself in the article. Of professionals you may expect a critical attitude, Everhardt says on request. “We operate women because they have prolapses that often mainly course inconveniences. Then it shouldn’t be that they get pain complaints in return.”
Fred Milani, chairman of the Team Pelvic Floor of the NVOG, says that because of the worrisome signals, he already sat around the table with the international professional group last year, to discuss this matter. Two weeks ago, the Dutch experts came with a joint position. The meshes don’t only cause misery, Milani declares. Dutch gynecologists did three studies in recent years on hundreds of women. They show that meshes can give a more sustainable result.
There is modest evidence of that added value, at short term, only in women who got a relapse after their first operation (by lack of support tissue). That is why the Dutch experts decided to use meshes only to that group in future. No profit has been demonstrated on using meshes in women who come for an initial surgical operation, like Emke de Graaf. In that group using meshes will only be allowed in scientific research.
Milani speaks of moving comprehension. ‘Looking back, things did not go well. On some of the women no meshes should have been used, and in some of the cases the operation hasn’t been executed correctly. We need to observe far more selectively whom we are going to treat with this material. ‘Women must be elaborately informed in future, he says, and also be reported about the alternatives; our law has been prescribing this for a long time.
Only experienced doctors must perform the surgery from now on, Milani declares; they're called urogynecologists: gynecologists who pursue pelvic floor problems. 'They must be exclusively trained and have accomplished quite a number of surgical operations under supervision before they can deliver provable quality. 'In addition, from the beginning of next year the occupational group wants to start to register the complications in a special national registration.
The problems were to be expected, gynecologist Everhardt says. Manufacturers of medicines must meet strict requirements. For medical devices like meshes, less strict rules apply, she explains. And when a medical device once is allowed on the market, the procedure for other comparable types gets easier. With the criticism on the meshes also in Britain and the USA the discussion about inadequate regulation broke loose.
Milani thinks that the Government should introduce stricter rules for the admission of medical devices. In the meantime his occupational group composed conditions for the introduction of devices in gynecology practices. ‘Manufacturers must submit animal studies and they should at least follow hundred patients a year to be able to judge safety and efficiency. They must also be able to show a registration of the results of surgery with thousand patients worldwide. ‘The pressure from the industry can be parried this way.
The four correction operations that Emke de Graaf had to undergo did not mend the damage that had been caused. After a long search she found a surgeon who dared to take the risk to remove the mesh. Unfortunately it only succeeded partially. Her prolapse should have been fixed the old way, by attaching the bowel to the sacrum. Ironically enough that won’t be possible anymore, because of the presence of the remains of the mesh.