Lupine Publishers | Pharmacology & Clinical Research
For more Pharmacology & Clinical Research Please Click
Here:https://lupinepublishers.com/pharmacology-clinical-research-journal/index.php
Abstract
Aim: On the background of reports
concerning harm to the health of users of a contraceptive product, the paper
aims at emphasizing the manufacturers’ responsibility to warrant safe use of
contraceptive pills and devices.
Method: The method consists in an analysis
of sources of information commonly used by women and their healthcare
providers, ie, “information for use“ provided by manufacturers and statements
by renowned agencies, such as WHO, FDA, National Center for Health Research,
and CDC. Also, research publications in scholarly journals are critically
analysed.
Results: Presently, women do not receive
information necessary for the safe use of contraceptive pills and devices --
neither from all pharmaceutical companies nor from healthcare providers.
Conclusion: Comprehensive,
complete, and reliable information on all available methods of contraception is
difficult to obtain. Pharmaceutical companies should be obliged by law to
inform the users of their products in a comprehensible manner about all risks and
potential complications without using a confusing, deceptive, or misleading
vocabulary.
Materials
Material
used comprises primarily information provided by manufacturers in packaging
labels and by the FDA in various publications. In instances where it seems
appropriate, pertinent scholarly articles published in the most prestigious
professional journals are critically analysed.
Methods
The
method consists in an analysis of information provided by various sources, such
as manufacturers, FDA, scholarly articles, and popularizing publications
emanating from academic institutions and clinics. This information is assessed
by analyzing the nomenclature used and by evaluating the reliability of data
presented. Criteria applied are principles of evidence-based research.
Findings
Pharmaceutical
companies frequently fail to provide comprehensive and comprehensible
information for the consumer, and users of their products are not always
enabled to make an intelligent choice, as is required by the principle of
informed consent.
Discussion
Recently,
one of the world’s leading pharmaceutical companies became the target of press
reports commenting on complaints about severe adverse events associated with
the company’s product for permanent contraception. According to these reports,
thousands of women experienced severe medical problems and filed lawsuits
against the company in the US and in other countries: “The implant has had a
troubled history. It has been the subject of an estimated 16,000 lawsuits or
claims filed by women who reported severe injuries, including perforation of
the uterus and the fallopian tubes. Several deaths, including of a few infants,
have also been attributed to the device or to complications from it [1].“ In
Australia the device had been withdrawn already in 2017, after women complained
about severe harm caused by the implant: “The device, known as Essure, is . . .
intended to block the fallopian tubes and permanently prevent pregnancy. But
there have been reports women experienced changes in menstrual bleeding,
unintended pregnancy, chronic pain, perforation and migration of the device,
allergic reactions and immune-type reactions after being implanted with the
device, which is manufactured by the pharmaceutical company Bayer [2].”
The
Manufacturer’s Description of the Implant for Sterilization and INSTRUCTIONS
for Use
The
medical and legal problems, including of class-actions [3], impacting on the
company’s business were due to a small nickeltitanium coil designed for
permanent contraception by way of sterilization. According to the company’s
product description, the device is an insert, ie, a soft flexible foreign
object that is inserted into each one of the fallopian tubes. The insert is
composed of a Nitinol (nickel-titanium alloy) outer coil and an inner coil of
316L stainless steel enclosed by polyethylene terephthalate (PET) fibers. In
addition, it contains platinum marker bands and a solder made of silver-tin
[4]. According to the manufacturer’s product description, the length of the
insert is 4 cm, and its diameter in the wound-down configuration is 0.8 mm [4].
When released, the outer coil expands in diameter up to 2.0 mm and conforms
itself to the shape and diameter of the individual patient’s fallopian tubes
[4]. In its marketing strategy, the company emphasized the uniqueness of the
non-incisional device and its approval by the FDA. “Essure is the only
FDA-approved non-incisional form of permanent birth control [5].” Concerning
the mechanism of action, the company specified that the “Essure system“ is
intended for permanent contraception by means of a “physical occlusion of the
fallopian tubes [4].“ Placement of the Essure-system is accomplished through a
transvaginal manoeuvre whereby the flexible spring-like insert is placed into
the lumen of the proximal portion of the fallopian tube where it anchors upon
release. Upon deployment, the outer coil expands, and by pushing against the
wall of the fallopian tube it anchors the device acutely in the lumen of the
fallopian tube [4]. Dynamic anchoring in the fallopian tube is followed by
occlusion of the fallopian tube through a benign tissue in-growth that leads to
contraception through sterilization. This “elicited“ in-growth of benign tissue
provides a permanent occlusion of the lumen of the fallopian tube and effects
permanent contraception [4].
At the same time,
however, it appears from a consumer’s viewpoint that the information is not
Given
the authoritative role played by the National Center for Health Research in
matters of health and consumer advocacy, it seems necessary to verify the
validity of the criticism voiced. What catches the eye of the critical reader
in the first place, is the explanation regarding the mechanism of action
furnished by the company. For this explanation a terminology is used which
might be confusing not only to the average consumer but even to educated
healthcare providers. The description of the occlusion of the fallopian tube,
which is the fundamental process for the contraceptive effect, lacks clarity
because it uses the terminology “elicits a benign tissue in-growth.“ From a
physiological viewpoint the causal agent and the process of the mentioned
tissue in-growth is unresolved [4]. In a different context, tubal occlusion and
tissue in-growth are explained with reference to PET, ie, “polyethylene
terephthalate fibers [4]”. Allegedly, these fibers cause tissue ingrowth which
facilitates not only retention of the insert but als tubal occlusion [4]. Not
only from a physiological but also from a biological viewpoint it is difficult
to understand how a device can “elicit” a benign tissue in-growth. Moreover,
whether tissue is benign and not malignant can be determined only through pathology
on the basis of a biopsy and not through a theoretical assumption a priori. It
is not surprising therefore that alternative explanations have been provided
which use the vocabulary “inflammation” and “fibrotic” ingrowth: “The small,
flexible inserts are made from polyester fibers, nickel-titanium, stainless
steel and solder. The insert contains inner polyethylene terephthalate fibers
to induce inflammation, causing a benign fibrotic ingrowth [7].”
For more Lupine Publishers Open Access Journals Please visit our website:
For more Pharmacology & Clinical Research Please Click
Here:https://lupinepublishers.com/pharmacology-clinical-research-journal/index.php
To Know more Open Access Publishers Click on Lupine Publishers
Follow on Linkedin : https://www.linkedin.com/company/lupinepublishers
Follow on Twitter : https://twitter.com/lupine_online
Follow on Twitter : https://twitter.com/lupine_online
