Pelvic floor descent repair with modern mesh implants: The benefits outweigh the acceptable risks

04/20/2017

Stuttgart – At a press roundtable on 20/04/2017, pfm medical ag and principal investigator Dr. Christian Fünfgeld (Klinik Tettnang GmbH) presented the results of a large, prospective, multicentre trial on surgical repair of genital prolapse with second-generation alloplastic mesh implants. The long-term data, as well as the clinic reports from Tina Cadenbach-Blome (Ev. Amalie-Sieveking Krankenhaus, Hamburg, Germany) and reports from two affected patients, confirm anatomically stable outcomes and a significant improvement in quality of life over a follow-up of 36 months. Monika Rieck (pfm medical ag) stressed the importance of reliable study findings for physicians when selecting appropriate treatment modalities and optimally assessing their benefits in patient care.

In genital prolapse organs such as the bladder, uterus or bowels descend down to the vaginal opening or even prolapse, depending on severity. “Anyone can understand that these patients suffer greatly”, explained Tina Cadenbach-Blome, Deputy Head of Department at Ev. Amalie Sieveking-Krankenhaus, Hamburg, Germany. “Many women not only suffer from physical symptoms such as impaired bowel or bladder function, pain or a marked foreign body sensation. Social domains of life such as relationship, sexuality and leisure activities may also be affected.”

Pelvic floor prolapse has a high prevalence and incidence

About half of all women who have given birth suffer from descensus of the uterus, bladder or vagina. Physicians initially try to correct this prolapse nonsurgically. “In the early stages of prolapse, we can already help many patients with pelvic floor exercises or pessaries”, explained Cadenbach-Blome.

It is only after the medical options have failed to provide relief, in case of relapse, or if the descensus is already too pronounced that surgical repair with mesh implants becomes the best option.

“The relapse rates are very high with standard prolapse surgery,” the gynaecologist reported. “That is why in recent years alloplastic mesh implants have increasingly been used.” But while these implants offered anatomical reinforcement, they have also been associated to some extent with increased complication rates. High-volume mesh surgery at specialised departments with experienced surgeons and modifications of the materials were able to establish mesh surgery as a reliable treatment modality.

With the TiLOOP® Total 6 pfm medical developed a second-generation mesh implant to improve patient treatment. “The titanium coated TiLOOP® Total 6 mesh is biocompatible and is incorporated quite well by the body’s tissue”, explained Monika Rieck, Director of Surgery at pfm medical ag, Cologne, Germany.

The material is titanised by special plasma coating which pfm medical uses, as the only manufacturer worldwide, for mesh implants. Compared to polypropylene, the hydrophilic, titanium-coated surface is associated with a lower risk of inflammation, and thus less scarring tendency.1 Other benefits included less mesh shrinkage2 and better tissue ingrowth.3

The manufacturer pfm medical does not want to rely solely on the characteristics of the material. “In addition to developing a high-quality product that achieves good surgical outcomes, our aim is significantly improving quality of life for patients”, said Rieck.

That is why pfm medical invested in a large prospective trial to study over a period of 36 months whether the benefits of using the six-armed, titanium-coated TiLOOP® Total 6 mesh implant actually outweigh the mesh-induced risks for patients.

“The long-term data available now confirm that trained surgeons can achieve demonstrated success with surgical prolapse repair using current surgical techniques and the state-of-the-art TiLOOP® Total 6 implant”, Rieck summed up.

Better reinforcement, higher quality of life and low complication rate

In the multicentre, 36-month trial, 289 patients with symptomatic cystocele (stage >= II or symptomatic stage I, POP-Q classification*) underwent surgery with the TiLOOP® Total 6 titanium-coated polypropylene mesh.

The long-term results show anatomically very stable results after 36 months with a very low relapse rate (4.5 percent). “In our opinion, the apical and lateral fixation of the six-armed implant provides the necessary reinforcement in the compartment operated on”, explained Dr. Christian Fünfgeld, Head of the Department of Gynaecology and Obstetrics at Klinik Tettnang GmbH, Germany, and principal investigator.

During follow-up QoL improved steadily in all nine domains examined.** The patients reported fewer prolapse pains as well as an improvement in the key domains of relationships and sexuality. Before surgery, 48.6 percent of patients felt their sex lives were adversely affected, while only 14.4 percent felt this way after 36 months. Before surgery, genital prolapse affected 37.9 percent of women negatively in their relationships, while only 11.4 percent were affected 36 months after the surgery.

“We achieve excellent results for long-term reinforcement and QoL with low complication and erosion rates – a significant advance over previous cystocele repair with mesh implants”, said Fünfgeld. In the 12-month follow-up, erosion, as defined in the study protocol, was seen in 10.5 percent (30/286) of patients. Among these, 17 cases were asymptomatic.

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References: 

Press roundtable “Get out of the taboo zone – and back into life! Trial demonstrates for the first time: Modern mesh implants can effectively and sustainably improve quality of life for women with pelvic floor prolapse” by pfm medical ag, 20/04/2017 Stuttgart 

1 Scheidbach et al. Surg Endosc (2004) 18: 211-220

2 Scheidbach et al. Eur Surg Res (2004) 36: 313-317

3 Klinge et al. Hernia (2012) 16: 251-258

* POP-Q classification: Pelvic Organ Prolapse Quantification System

** Lenz et al., 2009; 6/2009;20(6):641-9.  

To the video interview with two affected women and patients who underwent surgery.

For more information on the repair of cystocele defects with mesh implants, you can also read the  press release of the 12-month results for this trial (2016)

 

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Short profile of pfm medical ag

pfm medical is one of the leading German providers of special solutions in the healthcare sector. The Cologne-based family company was founded in 1971, and has more than 500 employees at twelve locations around the world. In 2015, pfm medical realized an EBIT (earnings before interest and taxes) of 4.1 million euros from 102.1 million euros in sales. The medical products supplier has registered more than 80 patents, utility models and trademarks. 

As a specialist supplier of 3,100 products, the company offers an extensive portfolio which is distributed in more than 100 markets. Its products extend to the following four key medical areas: Infusion (e.g. infusion pumps and implantable port catheters), surgery (e.g. drainage systems and mesh implants), histotechnology (e.g. blades and laboratory equipment) and cardiovascular technology (e.g. implantable occluders and special catheters).

pfm medical integrates products and services into a comprehensive solution package. For instance, the company provides training and advice to users such as medical practitioners, nursing staff, patients and their families to ensure optimal therapy outcomes in both inpatient and outpatient healthcare. In the development of innovative solutions in close cooperation with leading medical practitioners and specialist partners, pfm medical invariably focuses on improvements in the quality of work and the quality of life of both users and patients.

Press contact

pfm medical ag 
Ute Ebers 
Head of Corporate Communications 
Wankelstraße 60 
50996 Köln 
T +49 (0)2236 9641-370 
F +49 (0)2236 9641-99370 
ute.ebers[at]pfmmedical[dot]com
   pfm medical ag 
Nicole Tholfus 
Corporate Communications Manager 
Wankelstraße 60 
50996 Köln 
T +49 (0)2236 9641-373 
F +49 (0)2236 9641-99373 
nicole.tholfus[at]pfmmedical[dot]com

Dr. Christian Fünfgeld Chief physician Klinik Tettnang GmbH

Tina Cadenbach-Blome Leading senior physician Ev. Amalie Sieveking-Krankenhaus

Monika Rieck Director Surgery pfm medical ag

TiLOOP® Total 6