The Netherlands and Belgium Emke de Graaf and Isabella Mertens
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 for three years now (from 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 >>>
Forum where they meet fellow sufferers: www.medischforum.nl/gynaecologie >>>
News from the European Parliament
On the 24th of January in Brussels the ENVI debate on the defective silicone gel breast implants took place. During that debate French Green Party member Michèle Rivasi was able to also bring up the topic "meshes". The European Commission declared to be busy doing investigations onto the case. They are currently working on a revision of the legislation around medical devices and now accomplishing "stress-tests" to see where things go wrong within the current legal framework.
Later that day a couple of Dutch and French Green Party members sent a mail to the Directorate-General for health (DG Sanco) of the European Commission with additional information. They asked if it would be possible to also include the problems with meshes in those stress-tests and in the revision of the legislation.
Dear Ms Testori-Coggi, dear Ms Lecrenier,
As a follow-up on the ENVI debate on the defective silicone gel breast implants, please find below more information on the vaginal meshes that were mentioned by Green MEP Michèle Rivasi. Our office was made aware of this case by a citizen from the Netherlands. Apparently the FDA already gave a firm warning about the meshes since they seem to lead to serious complications.
Our question is if you can include the mesh case in the stress tests that you are currently conducting and if you can take it on board in the review of the legal framework on medical devices? This mesh case seem to highlight once again that there might be problems with the approval of medical devices. More information can be found here, www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm >>> but see also the below text taken from this website:
"In particular, the literature review revealed that:
1. Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair. 2. Mesh placed abdominally for POP repair appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh. 3. There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) with mesh provides any added benefit compared to traditional surgery without mesh. 4. While transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results.
The FDA’s literature review found that erosion of mesh through the vagina is the most common and consistently reported mesh-related complication from transvaginal POP surgeries using mesh. Mesh erosion can require multiple surgeries to repair and can be debilitating for some women. In some cases, even multiple surgeries will not resolve the complication.
Mesh contraction (shrinkage) is a previously unidentified risk of transvaginal POP repair with mesh that has been reported in the published scientific literature and in adverse event reports to the FDA since the Oct. 20, 2008 FDA Public Health Notification. Reports in the literature associate mesh contraction with vaginal shortening, vaginal tightening and vaginal pain.
Both mesh erosion and mesh contraction may lead to severe pelvic pain, painful sexual intercourse or an inability to engage in sexual intercourse. Also, men may experience irritation and pain to the penis during sexual intercourse when the mesh is exposed in mesh erosion." See furthermore here www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm >>> for the latest update of the FDA (4 January 2012). And here www.bloomberg.com/news/2012-01-04/fda-orders-safety-studies-for-vaginal-implants-made-by-j-j-and-c-r-bard.html >>> for a Bloomberg article on the case.
France eyes EU move amid breast implant scandal
Published Jan. 5, 2012 9:51 AM ET
JAMEY KEATEN, Associated Press
PARIS (AP) — France wants the European Union to stiffen its rules on authorizing medical devices amid a breast implant scandal involving a French company and affecting tens of thousands of women worldwide, the health minister said Thursday.
Xavier Bertrand called for "an unprecedented change" in EU rules to put authorizations for medical devices, including silicone breast implants, on a par with rules already in place for prescription medicines.
The implants, made by now-defunct French company Poly Implant Prothese, were pulled from the market last year in several countries in and beyond Europe due to fears they could rupture and leak silicone into the body. France has recommended that the estimated 30,000 women in France with the implants get them removed after more than 1,000 ruptures, and agreed to pay for the procedure.
The whereabouts of the company's former director, Jean-Claude Mas, are unclear — and he is being sought by authorities.
The scandal has put pressure on French health authorities for allegedly not doing enough to vet the quality of a product used by untold thousands of women both in France and abroad.
Jean-Yves Grall, France's top doctor as head of the national health directorate, was holding a closed-door meeting with industry players and top health officials on Thursday.
"We need new rules ... and this modification needs to happen at the European level," Health Minister Bertrand told LCI TV. He said he planned a conference call on the matter with EU counterparts.
Frederic Vincent, spokesman for EU Health and Consumer Policy Commissioner John Dalli, said Brussels had already planned to revise its directive on medical devices — which covers some 10,000 items, as varied as bandages, contact lenses and hip replacements — in the first half of 2012. It would strengthen national regulators and improve information-sharing.
Vincent acknowledged that "traceability is an issue" and said that at the moment each member government is responsible for tracing medical devices used by patients in its country.
France's Health Safety Agency has said the suspect PIP implants appear to be more rupture-prone than other types. Investigators say PIP sought to save money by using industrial silicone — whose potential health risks are not yet clear.
But Wednesday, Australia's medical watchdog said health officials had found no evidence that the PIP implants had an increased risk of rupture in Australian women, and said lab testing of the silicone gel used indicated that it was non-toxic to the tissue around the implant even if it did rupture.
Authorities in places such as Britain and Italy have asked hospitals and private clinics to track down women who received the implants. Several countries, including Colombia and Venezuela, have agreed to use state money to pay for the removal of the suspect implants. In some other countries, recipients have demanded to have their governments pay for replacements, too.
PIP's website said the company had exported to more than 60 countries and was one of the world's leading implant makers. The silicone-gel implants in question are not sold in the United States.
According to estimates by national authorities, over 42,000 women in Britain received the implants, more than 30,000 in France, 9,000 in Australia and 4,000 in Italy. Nearly 25,000 of the implants were sold in Brazil.
Please click the link below to view the full article:-
Volkskrant The Netherlands
Dated: 12th December 2011
Investigation on meshes used in prolapse surgery
Please click here to open a PDF for more information Volkskrant-The-Netherlands-Investigation-on-meshes-used-in-prolapse-surgery.pdf >>>