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Name

Study Number
Bachelor Study
E-mail

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Dwisetya Safirna Widyaratih


4491408
Mechanical Engineering
dwisetyasafirnawidyaratih@student.tudelft.nl

Part I:
Transvaginal Mesh for Reconstructing Pelvic Organ Prolaps (POP)
Pelvic Organ Prolapse (POP) is the condition when the pelvic organ descended from its
normal position (herniation) due to weakening of muscles, ligament, or fascia that support the
organ. There are three types of POP (figure 1), which are anterior compartment prolapse,
posterior compartment prolapse, and uterine prolapse [1]. There are several ways to treat POP,
depend on severity of the prolapse. In the early stage of POP, the patient can be treated with
non-surgical option by doing kegel exercise to strengthen pelvic muscle. The other treatment
is inserting ring pessary to support the organ. If the POP is getting worse, doctor will offer a
surgical treatment. If the patient is not sexually active anymore, the doctor usually recommends
vaginal closure surgery (Colpocliesis). In the other hand, for a sexually active woman, the
doctor will do a reconstructive surgical repair by inserting a surgical mesh to support the organ
to reconstruct the organ and retaining the sexual function (figure 2A &B).

Figure 1Pelvic Organ Prolapse Types [1]

For the past years, surgical mesh has been widely used to reconstruct the pelvic floor
(transvaginal mesh). In the Netherlands more than 13,000 surgical procedures each year

have been performed to correct POP [2]. Transvaginal mesh has a relatively easy procedures
to be inserted in the body and provides a good anatomical result. It is made from polypropylene,
polytetrafluoroethylene, or polyester fibers. Surgical mesh was firstly used to treat abdominal
hernias in the 1950s. Then, in 1970s, another functionality of abdominal surgical mesh was
induced to correct POP. The first surgical mesh product intended for vaginal was approved by
FDA in 2002 [3].
This reconstructive surgery for POP is an incision surgery. The surgeon use 3 main
tools, which are anatomic curvature, retrieval device, and cannula (figure 2C). Firstly, incision
is proceed by anatomic curvature and cannula. The incision starting point is 3cm below and
3cm lateral from anus. Surgeon hand guide the direction of the tools to pass through the
sacrospinous ligament and enter rectovaginal space. Next, the anatomical guideline is carefully
removed and leave the cannula inside to hold its position. The retrieval device is inserted via
cannula and retrieve from rectovaginal space. The retrieval device is pulled out from vagina
therefore it has two ends, one is from vagina and the other is from cannula. The last step is
inserting the transvaginal mesh. The transvaginal mesh is tied to the retrieval device that come
out from the vagina. The retrieval device is pulled from the other end, resulting the transvaginal
mesh pass through the vaginal space, cannula, and retrieve in incision point. Then the cannula
is removed, leaving the transvaginal mesh inside the body. For a complete animation of the
surgery, access https://www.youtube.com/watch?v=LBSh-VLuid4.

Figure 2 (A & B) Transvaginal Mesh Inside Body [4] [5], (C) Surgical Tools (Gynocare Prolift, Johnson & Johnson Brand)

However, reconstructive surgery didnt seem to remedy the patients. The transvaginal
mesh is intended to be permanently hold the prolapse. After few years of implantation, there
are several complications of transvaginal mesh. If we look at the history of transvaginal mesh,
this product was not exactly designed for pelvic floor. It based on the characteristics of
abdominal hernia meshes. The complication occurred because vagina have completely
different biomechanical properties than the abdominal wall [6]. Moreover, the other problem
of transvaginal mesh can result from degradation of meshs material as a result of it is not inert
and not biocompatible. As consequence, the material will degrade and become brittle. It will
produce toxic compound and restricts movement in pelvic area, increases the risk of

inflammatory and erosion [6] [7]. This oxidation process and will occur continuously in patient
for lifetime. It will become more and more painful for the patient so the surgeon must do
another operation for revision surgery to remove the mesh. In July 2011, FDA (Food and Drug
Administration) warned of serious complications associated with pelvic reconstruction surgery
using transvaginal mesh. They received nearly 4,000 complaints between 2005 and 2010.
About 75,000 women filed lawsuits against the manufacturers of transvaginal mesh products
[3].
Facing lots of complaints and dead ends in conventional transvaginal mesh, researcher
start to evaluate the material of transvaginal mesh. The researcher need to discover a new
technological solution from engineering science. The failure of transvaginal mesh arise from
the selection of material. There are many choices in degradable material but it will just hold
the organ for the period of time. Another reconstructive surgery still have to be done to insert
a new mesh. The most suitable material for permanent usage of transvaginal mesh is titanium
(Ti). Titanium has been commonly used for implant. It is biocompatible, nontoxic, and
corrosion resistance. It can be equipped in the pelvic for permanent use without any
complication. But how to insert the titanium in the organ without an open incision? How does
the titanium passing through the cannula?
The best solution is using nitinol as the material of the transvaginal mesh. Nitinol is a
unique material that formed from titanium and nickel (Ni). It has a superelastic and shape
memory behavior. The performance of nitinol is undoubtedly, it has been extensively exploited
by medical device industry since the late 1980s [8]. The shape and geometry of nitinol
transvaginal mesh duplicate the conventional transvaginal mesh. The procedures of insertion
is the same as well. It is also uses anatomic curvature, retrieval device, and cannula. Nitinol
can be flexible enough for insertion through the cannula. After inserting the nitinol mesh inside
the cannula, it will recover from the deformation and fit in the pelvic organ properly. Another
benefit of using nitinol as transvaginal mesh is MRI compability. It is safe to perform MRI for
the patient. This imaging can be used for evaluation after the surgery and controls the patients
condition.

I hereby state that this essay contains my own ideas and it was written by myself.

[1]
[2]
[3]
[4]

[5]
[6]
[7]
[8]

I. U. Association, "Pelvic Organ Prolapse: A Guide for Women," 2011.


A. Vollebregt, Polypropylene Mesh in Anterior Vaginal Prolapse Surgery : Efficacy, Safety, and Cost,
Waddinxveen: Off Page, 2012.
"Drug Watch," 2015. [Online]. Available: http://www.drugwatch.com/transvaginal-mesh/. [Accessed 24 October
2015].
A. L. F. Association, "Transvaginal Mesh Settlement," [Online]. Available:
http://www.transvaginalmeshsettlement.com/legal-options-transvaginal-mesh/what-is-transvaginal-mesh/.
[Accessed 24 October 2015].
"Injury Lawyer News," 19 August 2014. [Online]. Available: http://injurylawyer-news.com/transvaginalmesh/stress-urinary-incontinence/. [Accessed 24 October 2015].
Expert Report of Prof. Dr. Med Bernd Klosterhalfen, M.D., 2015.
D. Ostergard, "Polypropylene vaginal mesh grafts in gynecology.," The American College of Obstetricians and
Gynecologists, vol. 116, no. 4, pp. 962-966, 2010.
P. P. Poncet, "Application of uperelastic Nitinol Tubing," MEMRY Corporation, California.