This briefing describes the regulated use of the technology for the indication specified, in the setting described, and with any other specific equipment referred to. It is the responsibility of healthcare professionals to check the regulatory status of any intended use of the technology for other indications and settings.
The PolySoft hernia patch is a class I medical device which received its CE mark in November 2005. The CE mark is held by Davol Inc., a subsidiary of CR Bard Inc., for the design, development and manufacture of partially absorbable and non‑absorbable synthetic meshes for soft tissue repair.
The PolySoft hernia patch is a self‑expanding, non‑absorbable, sterile mesh for the repair of inguinal hernias using a pre‑peritoneal technique and an anterior approach. The mesh is supported by a monofilament polyethylene terephthalate memory recoil ring, which has a gap in it to allow the patch to be cut to create a slit for the spermatic cord if needed. The patch is supplied in boxes of 2, and is available in medium (14×7.5 cm) and large (16×9.5 cm).
This patch is not suitable for people under the age of 18 because using mesh in hernia repair may compromise future growth in this age group.
The PolySoft hernia patch is considered here only in use with the ONSTEP hernia repair surgical technique for direct and indirect inguinal hernias. The PolySoft hernia patch is currently the only patch designed to be used with the ONSTEP surgical technique, although it is possible to use the patch with other hernia repair techniques.
The ONSTEP technique is an open variation of the totally extraperitoneal repair laparoscopic technique. It can be carried out under local or general anaesthetic. After the site is prepared, a 4 cm horizontal incision is made in the lower abdomen. In men, the spermatic cord is isolated and an incision made in the transversalis fascia. This allows a 20×20 cm gauze to be inserted behind the transversalis fascia into the pre‑peritoneal space, to dissect the space needed for the hernia patch. A slit is cut into the PolySoft hernia patch through the gap in the memory recoil ring. The patch is positioned with the spermatic cord within the slit and the 2 tails of the patch are stitched together using 3 sutures. The gauze is then removed from the patient and the patch is inserted into the pre‑peritoneal space and smoothed with the fingers. The patch is fixed in place by fibrous tissue which forms after surgery, unlike other techniques where sutures or clips are used. The incision in the skin can be repaired using the surgeon's choice of suture and technique. In women, the patch is not split and is placed completely pre‑peritoneally.
If the inguinal hernia is not in a position where the spermatic cord is within the area of the patch, the stage in which a slit is cut in the patch can be omitted.
The manufacturer's instructions for use warns that where the patch is cut, care must be taken to ensure that the ring remains intact, because damage to the memory ring can cause complications such as bowel or skin perforation and infection.
The PolySoft hernia patch with the ONSTEP technique would be used for inguinal hernia repair in general operating theatres. Surgeons who perform this technique should be suitably trained and regularly carry out the procedure.
There are a wide range of inguinal hernia repair options available on the NHS and the PolySoft hernia patch with the ONSTEP technique would be used instead of other current hernia repair methods. Surgical repair can be carried out as either an open or laparoscopic procedure, with or without mesh. Mesh repair is recommended over sutured repair because the rate of hernia recurrence is lower (Jenkins and O'Dwyer, 2008). This is supported by an intervention review from the Cochrane Library comparing laparoscopic and open techniques for inguinal hernia repair (McCormack et al. 2003). McCormack et al. also concluded that there was no apparent difference in hernia recurrence between laparoscopic and open methods that use mesh. Although patients whose inguinal hernia was repaired using laparoscopic methods experienced less post‑operative pain and numbness and a shorter recuperation period, the length of operation was increased and the serious complication rate was higher than for open techniques.
Laparoscopic surgery for inguinal hernia repair (NICE technology appraisal guidance 83) recommends laparoscopic surgery as a treatment option for inguinal hernia repair. The guidance also recommends that people should be informed of the risks and benefits of both open and laparoscopic hernia repair, to allow an informed choice to be made.
There is limited information available on the mortality rates associated with hernia repair in England. Bay‑Nielsen et al. (2001) published results from a Danish hernia database, which concluded that for elective surgery, the 30‑day mortality rate was 0.02% for patients under 60 years old and 0.48% for those over 60. For emergency surgery, this rate rose to 7% for all age groups.
NICE is aware of the following CE‑marked devices with appropriate repair techniques that have a similar function to the combination of the PolySoft hernia patch used with the ONSTEP technique:
Kugel hernia patch with Kugel hernia operation (Bard)
PROLENE Polypropylene Hernia System (Ethicon)
Based on information from the manufacturer, the PolySoft hernia patch costs £116.30 per box excluding VAT. The patch is designed to be non‑absorbable and permanent, so its anticipated lifespan is the lifetime of the patient having the hernia repair. One patch is used per inguinal hernia repair procedure and a patient might have 1 or 2 inguinal hernias. There is no publicly available information on how much the ONSTEP technique costs, but the weighted average cost of inguinal, umbilical or femoral hernia procedures (NHS reference costs 2012/13 codes FZ18E, G–K) is £1754 (Department of Health 2013), and could be considered the average cost per treatment. The NHS reference cost comprises capital, human resources, training and overheads and includes the cost of any patch material used. One specialist commentator observed that the unit cost of the PolySoft hernia patch is similar to that of others; although cheaper patches are available, some patches are much more expensive, particularly those used for laparoscopic umbilical or ventral hernia repairs. Therefore it is reasonable to use an overall weighted average cost. Another specialist commentator noted that the ONSTEP technique appears to be prohibitively expensive in patients for whom an open Lichtenstein‑type repair was otherwise being considered. Without evidence on cost estimates of different techniques, conclusions on the resource implications of the ONSTEP technique using the PolySoft hernia patch cannot accurately be drawn.
Surgeons may take time to learn the ONSTEP technique, but literature reports that it is a predictable short learning curve (Lourenço and da Costa, 2013). No other practical difficulties have been identified in using or adopting the technology.
The PolySoft hernia patch with the ONSTEP technique would be presented as an option in the standard clinical pathway for surgical inguinal hernia repair.
One specialist commentator thought that for established surgeons the operation duration is comparable for laparoscopic and open procedures, and that the risk of serious complications is low for both types of procedure.
It was also noted by 1 specialist commentator that if the hernia recurs after initial repair using the ONSTEP technique, it may be more difficult to correct than with other procedures. This is because the patch is placed only partly pre‑peritoneal, with some of the patch placed in the conventional plane used with the open Lichtenstein repair technique.
Another specialist commentator noted that the unit cost of the PolySoft patch is similar to that of others, and that it was reasonable to infer an overall weighted average cost of inguinal, umbilical or femoral hernia procedures for the ONSTEP technique.
One specialist commentator added that there may be financial implications when using the ONSTEP technique for hernias in patients for whom standard open surgery was being considered, and that this was unlikely to be true for patients being considered for laparoscopic surgery. Another specialist commentator thought that adoption of the ONSTEP technique would be resource‑neutral; hospital stay, operative time and complication rate would be the same as for any other open hernia technique.
One specialist commentator noted that the ONSTEP procedure is noticeably quicker than other conventional or laparoscopic hernia repair techniques, and that this is an advantage over other, cheaper meshes.
NICE is committed to promoting equality and eliminating unlawful discrimination. We aim to comply fully with all legal obligations to:
promote race and disability equality and equality of opportunity between men and women, and
eliminate unlawful discrimination on grounds of race, disability, age, sex, gender reassignment, pregnancy and maternity (including women post‑delivery), sexual orientation, and religion or belief, in the way we produce our guidance. (NB these are protected characteristics under the Equality Act (2010).
Inguinal hernias are more common in men than in women. Sex is a protected characteristic under the Equality Act (2010).
The PolySoft hernia patch with the ONSTEP technique is not suitable for people under 18 years, a group covered by the Equality Act (2010), because using mesh in hernia repair may compromise future growth in this age group.