Share
News
-
25 October 2012 | Updated 26 October 2012 /Product areas
Criticism of CE marking of medical devices in Czech Republic and Slovakia
The Danish Health and Medicines Authority has asked the European Commission to take action in a case concerning whether two named notified bodies in the Czech Republic and Slovakia comply with EU medical devices law.
-
22 August 2012 | Updated 27 August 2012 /Product areas
Danish hospitals advised to call in women having received synthetic mesh implants
The Danish Health and Medicines Authority advises Danish hospitals to call in women who have received surgical mesh for pelvic organ prolapse for consultation, examination and evaluation.
-
10 July 2012 /Product areas
Surgery with the da Vinci Surgical System resumed in Denmark
Robotic surgery using the da Vinci Surgical System will resume Tuesday 10 July in Denmark, after having been halted for the past two weeks. The decision to resume surgery with the da Vinci Surgical System was taken by the five national robot centres based on an independent investigation and further documentation from the manufacturer Intuitive Surgical.
-
20 June 2012 /Product areas
NHS publishes final report into the safety of PIP implants
An expert group under the National Health Service (NHS) in Britain has published a thorough report on PIP implants. The exhaustive worldwide testing of the PIP gel has not revealed anything that could cause a long-term threat to human health. The implants are not toxic and do not cause cancer. But the risk that the PIP implants may rupture is around two times higher than it is for other brands of implants - around 6-12% after 5 years, and 15-30% after 10 years, whereas the risk associated with other brands is 10-14% after 10 years. The contents of the PIP implants are therefore not harmful, and the gel has not been shown to contain any toxic substances, but the poorer mechanical durability makes the PIP implants a substandard product.
-
16 March 2012 /Product areas
New knowledge about silicone breast implants manufactured by Poly Implant Prothèse
The Danish National Board of Health has been informed by the French health authorities that PIP silicone breast implants, manufactured before 2001, are suspected of leaking silicone more frequently than other implants. Previous warnings have only covered implants manufactured after 2001. However, the Danish National Board of Health is not aware that any PIP implants (also sold under the name Rofil) have been sold in Denmark before 2004.
-
03 February 2012 /Product areas
International risk assessment of PIP implants
The EU Commission has just published a scientific risk assessment of breast implants from the French company PIP, Poly Implant Prothese. The report goes through the problems related to the implants, e.g. the frequency of leaking and the risk of various types of cancer. The main conclusion of the report is that the available data is still too limited to determine conclusively whether or not PIP implants are associated with health risks.
-
01 February 2012 /Product areas
French authorities have published report on PIP implants
The French authorities have just published a report on the PIP implants. The report contains the information that until now had been kept confidential. The Danish Medicines Agency has thus been given permission by the French authorities to publish the documents to which we were requested to grant access.
-
01 February 2012 /Product areas
Danish Medicines Agency is pressing for publication of information about PIP implants
The Danish Medicines Agency has been requested to grant access to documents from France that contain detailed information about the PIP implants.
-
24 January 2012 /Product areas
Problems with ASR hip implants from DePuy
The ASR hip implants from the company DePuy were recalled from the Danish market in August 2010. The product was placed on the Danish market in July 2003. As far as the Danish Medicines Agency knows, up to 618 patients in Denmark may be affected by this matter.
-
05 January 2012 /Product areas
PIP implants on the Danish market
The Danish Medicines Agency presently knows of 66 breast implants in total from the French manufacturer PIP, which may have been used in Denmark. The implants are suspected of leaking silicone more frequently than other implants. At the same time the silicone used is not authorised for breast implants. A previous suspicion about an increased cancer risk for users of these implants has turned out to be incorrect.
-
03 January 2012 /Product areas
The Danish Medicines Agency repeats its warning against silicone breast implants manufactured by Poly Implant Prothèse, France
A group of experts in France are investigating the possible connection between PIP breast implants and eight women with breast implants who have developed tumours. In April and September 2010, the Danish Medicines Agency warned against these breast implants, and now we are repeating the warning.
-
02 January 2012 /Product areas
Removal of PIP implants not recommended routinely
On 23 December, the French regulatory authorities, AFFSAPS, announced that there is no identifiable causal relationship between cancer and breast implants from the French company PIP, Poly Implant Prothèse. Based on the available knowledge, the Danish National Board of Health and the Danish Medicines Agency recommend not to remove PIP implants as a routine measure.
-
21 December 2011 /Product areas
Patients treated with Visco Supreme may claim compensation via the Danish Patient Insurance Association
The Danish Medicines Agency has received 44 reports on cases of infection of the interior of the eye (endophthalmitis) following treatment with Visco Supreme (batch nos.11A03 and 11D04) from CLR Medicals International Inc. A total of 93 treatments were made with the products in question.
-
23 November 2011 /Product areas
Eye surgical solution recalled due to risk of inflammation within the eyeball
The Danish Medicines Agency has received reports of at least five cases of inflammation within the eyeball (endophthalmitis) caused by the use of a specific consignment of the product Visco Supreme from CLR Medicals International Inc. (lot no.11A03).
-
12 April 2011 /Product areas
More reports of medical device incidents in 2010 in Denmark
In 2010, the Danish Medicines Agency experienced a 23 percent increase in the number of reported serious incidents with medical devices, from 1128 in 2009 to 1383 in 2010.
-
20 December 2010 /Product areas
Check your Mini Crosser el-scooter if it is more than four years old
Older versions of el-scooters (Model T and Model Nordic) could have problems with the electronics and therefore need to be adjusted.
-
29 September 2010 /Product areas
Problems with breast implants
On 8 April 2010, the Danish Medicines Agency warned against the use of breast implants pre-filled with silicone based gel labelled IMGHC-TX, IMGHC-MX or IMGHC-LS manufactured by the French company Poly Implant Prothèse.
-
02 September 2010 /Product areas
Much debated dental crowns pose no health risk
On 29 August, DR TV (Danish Broadcasting Corporation) broadcast a story on the Danish company Oversea Labs about gold dental crowns.
-
31 August 2010 /Product areas
About gold dental crowns from Oversea Labs: Experts assess there to be no health risk associated with the dental crowns
On 29 August, DR TV (Danish Broadcasting Corportaion) broadcast a story on the Danish company Oversea Labs, revealing that the company's gold dental crowns according to DR's analysis of five teeth did not contain as much gold as they were supposed to.
-
09 April 2010 /Product areas
The Danish Medicines Agency warns against the use of silicone breast implants manufactured by Poly Implant Prothèse, France
The Danish Medicines Agency warns against the use of silicone gel filled breast implants marked IMGHC-TX, IMGHC-MX or IMGHC-LS manufactured by the French company Poly Implant Prothèse
