Industry Says EU Medical Device Sales Healthy, Silicone Scandal May Change That

February 10, 2012 ~ A survey by a medical device consultant, Emergo Group, released Friday, (news release here) February 10, finds that overseas sales of medical devices outpaced domestic business in 2011. Surveying more than 2,600 medical device makers, 53 percent reported a rosy sales picture last year. Compare that to 42 percent reporting positively about domestic sales.

The survey underscores the global issue of medical devices. The acronym BRIC, stands for Brazil, Russia, India and China where device makes have their sites set, according to a news release by Emergo. China is emerging as the prime market for the largest five-year growth potential.

Device manufacturers, and lawmakers who represent their interests to the FDA, constantly remind the agency that if rules are not relaxed device makers will take their products and profits overseas. But overseas may be learning from experience. Nearly 22 percent of those who were surveyed said the European market became more strict in 2011 requiring more clinical data. More than half of participants said the FDA has been more difficult since 2010.

Nearly 40 percent said they would choose Europe as the first place to market a new device.

Bad Breast Implants

All that may be changing with the PIP breast implant scandal. Thousands of women were implanted with breast implants made in France using industrial-grade silicone. (background story here). Regulators are now calling for tighter controls to safeguard patients. Weaker regulations in Europe are blamed for allowing Poly Implant Prothese (PIP) implants onto the market. Hundreds of thousands of women used the implants for up to a decade reports Reuters (here).

The national scandal in France has the government recommending women have the implants taken out with the government footing the bill. France did not offer to pay for replacement breast implants.

Green Party Says Meshes Need Review Too

During a debate in Brussels on defective silicone gel breast implants, French Green Party member, Michèle Rivasi brought up the topic of "meshes", reports Maria S. to MDND. The European Commission is currently working on a revision of the legislation around medical devices and now planning "stress-tests" to see where things go wrong within the current regulatory and legal framework.

Maria S. Says 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. Below you can read the text of their email:

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, but see also the below text taken from this website:

"In particular, the literature review revealed that:

• Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.
• Mesh placed abdominally for POP repair appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
• 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.
• 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 for the latest update of the FDA (4 January 2012). And here for a Bloomberg article on the case. #