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. The recommendation does not apply to women having received a biological mesh implant.
Synthetic mesh has been used to a limited degree since 2006 to treat prolapse of the vagina, bladder and womb after childbirth (the condition is also referred to as pelvic organ prolapse, POP). After implant in the vaginal wall, the synthetic mesh has been reported to cause complications such as pain (including pain during sexual intercourse) and bleeding.
The Danish Health and Medicines Authority estimates that between 300-400 women in Denmark have received a synthetic implant to treat POP.
The Danish Health and Medicines Authority now advises hospitals in Denmark to call in women for consultation in response to concerns raised by the authorities in other countries which currently follow the complications closely. Synthetic mesh has been used in Denmark since the mid-1990s to the benefit of thousands of women who suffer from urinary incontinence. The current concerns do not involve surgery for urinary incontinence, and it is important to stress that these women do not have to worry.
The Danish Health and Medicines Authority reminds treating physicians that they are obliged to report serious adverse events involving the use of mesh, because mesh is a medical device.
Pelvic organ prolapse implants have been used to treat prolapse of the vagina, bladder, womb, etc. to support the patient's own tissue, keeping it in place. The mesh used to treat pelvic organ prolapse are either made from biologic material or woven synthetic fibres, or a combination of the two, and they may be either absorbable or non-absorbable. The term surgical mesh is primarily used about mesh made from woven synthetic fibres.
Through the past two decades, mesh has gained ground in operations to treat stress urinary incontinence (SUI) by which a narrow strap (sling) is placed under the woman's urethra. This type of procedure is also called TVT surgery and has been performed in Denmark since the mid-1990s. The use of synthetic mesh to treat hernia and urinary incontinence has been relatively uncontroversial.
The problems having caused the U.S. Food and Drug Administration to issue warnings concern the use of synthetic mesh in POP surgery. Moreover, warnings have been issued against using certain types of mesh for SUI surgery. These types of mesh have not been used in Denmark for several years.
The use of surgical mesh for POP has been limited in Denmark compared to other countries in Europe and North America.