The pages you are about to visit include technical information about HERNIAMESH products.
In compliance with the guidelines of the Ministry of Health of 17 February 2010 and subsequent of 28/03/2013 and 20/12/2017, such information is addressed exclusively to specialized medical operators. Their consultation is carried out under the full responsibility of the user.
The products descripted in this section are medical devices. Medical staff must determine in advance the suitability of use of these products for a given patient. As with any medical device, there can be complications related to the use of such products. Therefore, before using the products, medical personnel must carefully read the instructions, possible side effects and contraindications written in the instructions included in the packaging of each product, along with all relevant medical literature. Medical personnel must inform their patients of all potential risks associated with the use of the product.
For patients considering to undergo a procedure which involves implantation of a surgical mesh for the treatment of urinary incontinence and/or pelvic floor prolapse, should be aware of the possible adverse events linked to this procedures, which are but not limited to:
- postoperative hematoma, seroma, abscess or fistula formation, or scarring which may occur following the implant procedure
- urinary retention, bladder outlet obstruction and other voiding dysfunctions
- perforations or lacerations of vessels, nerves, bladder, bowel, urethra, or any viscera, which may occur during or after the implantation procedure
- irritation at the operative wound site which may elicit a foreign body response that leads to wound dehiscence, inflammation and/or infection
- extrusion of the implanted mesh through vaginal epithelium or erosion into surrounding viscera and/or mucosa
- inflammation, sensitization, acute and/or chronic pain, dyspareunia, dysuria, scarification, contraction, device migration and failure of the procedure resulting in recurrence of incontinence and/or of prolapse.
Please, be aware that adverse events are not limited to those listed above.
Always ask your physician to provide you with comprehensive clinical datas on this type of surgeries.
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