ORIGINAL QUESTIONS SENT OCTOBER 30, 2018 BY CBC/SRC/TORONTO STAR
1. When approved in 2006, the TVT Secur System had not been tested in a patient,
according to published journal articles. One of these articles quotes an Ethicon
brochure instead quoting evidence from other similar devices it made to treat urinary
incontinence and “data on file” from animal and cadaver studies. Why wasn’t TVT
Secur System tested in humans prior to it being marketed?
2. Researchers have since criticized the “weak” evidence used to support the approval
of transvaginal mesh devices. Do you have any comment on this characterization?
3. According to records and testimony that have emerged through litigation, Ethicon
was aware that its Gynemesh Prolift had a failure or recurrence rate of 27 percent
within the first year, and continued to market its products as safe and effective. Why
was that complication rate acceptable?
4. Ethicon removed both TVT Secur System and the Prolift products from the Canadian
market in August 2013, according to Health Canada’s product database. Why were
these products taken off the market?
5. In 2012, the US FDA issued 522 orders to Ethicon and other mesh manufacturers
requiring the companies to conduct post-market surveillance studies. Some critics
say companies, including Ethicon, chose to withdraw certain products so they
wouldn’t need to conduct the studies. Do you have any response to this allegation?
Based on the FDA’s 2012 orders, what post-market surveillance studies has Ethicon
performed? For what products? What were the results?
We have spoken to Noreen Wideman, a British Columbia woman who was implanted
with TVT Secur System in June 2008 to treat urinary incontinence. Within six months,
her urinary incontinence returned. After a few years, she began experiencing
crippling abdominal and rectal pain, as well as infections and anemia she attributes
to a foreign body reaction. She later found blue filaments in her urine and in her
underwear, which she said was evidence the mesh was eroding. She would lose
control of her bowels and became suicidal. In December 2011, she had the mesh
removed. “I felt better than I had in months and months. The stabbing pain was gone.
It was like someone had taken the knife out,” she said. We understand that Ms.
Wideman has settled a lawsuit with Ethicon/J&J. Does Ethicon have any comments
on her description of the health problems she experienced after receiving her mesh?
Ethicon continues to have some vaginal mesh products approved in Canada. Device
regulators in some countries have banned or restricted the use of vaginal mesh,
saying the risks currently outweigh the benefits. In Australia, the government
suspended the use of meshes for pelvic organ prolapse. In the UK, the government
recently put a “pause” on the use of meshes for stress urinary incontinence “until a
set of conditions to reduce the risk of injury are met.” Do you have any comment on

 these regulatory actions?
Ms. Wideman recently petitioned Canada’s House of Commons to, among other
things: temporarily suspended the licensing of meshes until an oversight committee
determined the benefits continue to outweigh the risks; and, implement a mandatory
registry system for all implants, including meshes. Do you have any comment on
these two demands?
RESPONSE RECEIVED ON NOVEMBER 14TH, 2018
We appreciate the opportunity to provide information and to address several inaccuracies in
your questions about pelvic mesh.
The majority of women with pelvic mesh see an improvement in their day to day lives, and
Ethicon stands behind the safety of our devices, which have benefited millions of patients
who continue to find relief from the debilitating conditions that led to their surgeries. We also
empathize with any patient who has experienced a complication following their surgery. Our
products are developed to help patients, and knowing that all surgical procedures with or
without implantation of a medical device involve certain risks, a discussion between a doctor
and patient to weigh those risks on a case-by-case basis versus the benefits is a critically
important part of any pre-surgical process.
Our company believes a balanced regulatory system is important and Ethicon is open to the
continuous improvement of the medical device regulatory system. We meet and strive to
exceed, required regulatory standards, and our devices (such as those mentioned in your
email) are subject to careful reviews by multiple regulatory bodies around the world before
use. Once the device is licensed for use, we also continue to analyze information regarding
our devices, such as clinical data and adverse event reports, to track their performance.
Surgery with implantable mesh is backed by years of clinical research, has undergone
rigorous regulatory reviews and has been the preferred option for millions of women seeking
to improve their quality of life. Pelvic mesh devices remain an important treatment option for
certain female pelvic conditions. Our pelvic mesh products are made with Prolene
polypropylene, which has been safely used in millions of patients in almost every type of
surgery for half a century, including cardiovascular surgery, neurological surgery, and
general surgery.
No material in pelvic surgical history has demonstrated higher
biocompatibility than polypropylene and no polypropylene material has been used in more
patients or been subject to more peer-reviewed studies than Prolene.
The TVT devices are the most and longest studied option to treat stress urinary incontinence
(SUI). Data from clinical studies continues to be published supporting the devices, including
the recent publication of multiple 17-year TVT studies1
​Nilsson CG, Palva K, Aarnio R, Morcos E, Falconer C. Seventeen years' follow-up of the
tension-free vaginal tape procedure for female stress urinary incontinence. Int
Urogynecol J. 2013 Aug;24(8):1265-9. doi: 10.1007/s00192-013-2090-2. Epub 2013
Apr 6; Braga A, Caccia G, Sorice P, Cantaluppi S, Coluccia AC, Di Dedda MC, Regusci L,
1

 Please note that contrary to your assertions in question 1, TVT Secur (and the TVT mesh
used in the device) was tested in humans before it was marketed.
Prior to launching TVT Secur, which offered a less invasive surgery option for patients,
Ethicon also conducted numerous cadaver labs and animal studies to evaluate pullout
strength and fixation forces and holding ability of the mesh. These laboratory and clinical
studies, coupled with the decade long clinical history of both TVT and TVT-O, demonstrated
the safety and efficacy of TVT Secur. Prolene mesh proved to have high cure and patient
satisfaction rates, lead to improvements in patients’ symptoms and quality of life, and had
the best properties for safe and successful tissue integration in the TVT device. In fact, by
the early 2000s, there was 5-year data on the TVT device and the results of level one
randomized controlled human trials which showed the safety, benefits and efficacy of the
TVT mesh2
The early recurrence / failure rate related to PROLIFT that you reference in question 2 is
also incorrect.
The PROLIFT device, which is used to treat pelvic organ prolapse, has been shown, through
the highest level studies, to better treat prolapse than native tissue prolapse repairs, which
rely on deficient and weakened tissues that have already failed in the first place. The
PROLIFT device uses Gynemesh PS, an Ethicon large pore polypropylene mesh composed
of Prolene polypropylene. In total, more than 700 patients had been studied with Gynemesh
PS and transvaginal mesh before the launch of PROLIFT.
Prospective company-sponsored transvaginal mesh studies in the US and France were
conducted and showed a mean recurrence rate at one year of 15.3%, of which the majority,
Ghezzi F, Uccella S, Serati M. Tension-free vaginal tape for treatment of pure
urodynamic stress urinary incontinence: efficacy and adverse effects at 17-year
follow-up. BJU Int. 2018 Jul;122(1):113-117; Bakas P, Papadakis E, Karachalios C,
Liapis I, Panagopoulos N, Liapis A. Assessment of the long-term outcome of TVT
procedure for stress urinary incontinence in a female population: results at 17 years'
follow-up. Int Urogynecol J. 2018 Jul 7. doi: 10.1007/s00192-018-3713-4. [Epub ahead
of print].
2
​Nilsson CG, Kuuva N, Falconer C, Rezapour M, Ulmsten U. Long-term results of the
tension-free vaginal tape (TVT) procedure for surgical treatment of female stress urinary
incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12 Suppl 2:S5-8; Liapis A,
Bakas P, Creatsas G. Burch colposuspension and tension-free vaginal tape in the
management of stress urinary incontinence in women. European Urology.
2002;41(4):469–73; Ustun Y, Engin-Ustun Y, Gungor M, Tezcan S. Tension-free vaginal
tape compared with laparoscopic Burch urethropexy. Journal of the American Association
of Gynecologic Laparoscopists. 2003;10(3):386–9; Valpas A, Kivela A, Penttinen J,
Kujansuu E, Haarala M, Nilsson CG. Tension-free vaginal tape and laparoscopic mesh
colposuspension for stress urinary incontinence. Obstetrics and Gynecology.
2004;104(1):42–9; Paraiso MF, Walters MD, Karram MM, Barber MD. Laparoscopic Burch
colposuspension versus tension-free vaginal tape: a randomized trial. Obstetrics and
Gynecology. 2004;104(6):1249–58; Ward KL, Hilton P; UK and Ireland TVT Trial Group.
A prospective multicenter randomized trial of tension-free vaginal tape and
colposuspension for primary urodynamic stress incontinence: two-year follow-up. Am J
Obstet Gynecol. 2004 Feb;190(2):324-31.

 while technically recurrences, were not symptomatic. This was a significant improvement
over native tissue repairs, which showed failure rates of 30%-50% within the first year in
some studies that prompted surgeons to develop mesh based repairs.
Systematic reviews and meta-analyses have also proven that mesh based repairs, including
PROLIFT, have resulted in lower recurrence rates than the traditional native tissue repairs.
The most recent Cochrane review by Maher et al., which is a systematic review of clinical
studies that is recognized for using high standards of evidence-based medicine, compared
polypropylene transvaginal mesh repair including PROLIFT to native tissue prolapse repair
and found recurrent prolapse on examination was less likely after mesh repair than after
native tissue repair using only sutures. Patients reported significant improvement in their
quality of life and symptoms via the Quality of Life (QOL) and Prolapse Symptom Inventory
(PSI).
Regarding your questions concerning post market surveillance and regulatory issues, it is
important to understand that a 2011 FDA Advisory Committee ruled Ethicon’s currently
marketed pelvic mesh products are not subject to FDA’s 2012 or any FDA 522 orders. The
Ethicon devices are among the most studied in the world for these indications. For example,
over the last 20 years, over 150 randomized controlled trials have examined the TVT
devices and these highest-level studies overwhelmingly demonstrate that the TVT devices
are safe and effective, offering higher efficacy rates than the traditional native tissue
surgeries and low rates of complications.
Contrary to your suggestion, the clinical efficacy and safety of Ethicon pelvic mesh devices
are not dependent on other devices such as the Protegen sling. Companies do not select
the regulatory pathway for a device’s clearance, rather it is determined by the regulatory
agency. As such, Ethicon follows the proper regulatory guidance and performs robust initial
research and continued post-marketing assessments of its devices, including company
sponsored studies, investigator-initiated studies, and individual clinical trials performed by
clinical and surgical researchers. The results of these individual studies, systematic reviews
and meta-analyses document that these devices are useful, durable, efficacious and safe
within the context of pelvic surgery. Long-term data on the Ethicon devices continues to be
published. The data and evidence from hundreds of studies show the utility, durability, safety
and efficacy of these Ethicon devices. Ethicon continues to monitor, collect and evaluate the
clinical evidence of our devices’ performance and safety from numerous sources.
As it relates to your question about taking some of our products off the market, Ethicon
decided to globally decommercialize TVT Secur and PROLIFT, among others, after carefully
considering numerous factors. On a global basis the decision to decommercialize these
devices was a business decision, not related to device clinical performance and safety. We
continue to have confidence in the safety and efficacy of these products.
As to your question about regulatory action in the UK, Ethicon has not been contacted
directly or asked to take any action with regard to the marketing and distribution of pelvic
mesh in the UK by the regulatory authority, the Medicines and Health Products Regulatory
Agency (MHRA). ​The pause on the use of mesh for stress urinary incontinence was not

 supported by the British Society of Urogynaecologists (BSUG)​. BSUG advised that it “does
not agree with and strongly opposes the decision to pause/suspend the use of surgical mesh
for stress urinary incontinence….” Further, BSUG advised that the “decision is not based on
any scientific logic or thinking. This is the single most researched incontinence procedure in
the world and to therefore place a suspension on its use contradicts all the research,
scientific evidence and guidance issued by national bodies. This procedure has been the
mainstay of surgical treatment for women with stress incontinence over the last 20 years.
Good quality data suggest 95% of women remain free from any complications after this
surgery and the majority have markedly improved continence. Other surgical procedures
have higher risks and complications.”
Pelvic mesh has helped improve the quality of life for millions of women with serious,
debilitating conditions. Pelvic mesh devices remain an important treatment option for certain
female pelvic conditions, and the restricted use of transvaginal mesh devices for the
management of stress urinary incontinence or pelvic organ prolapse would limit access to an
important treatment option for some women.
In reference to your questions about Ms. Wideman, we respect her privacy and it would be
inappropriate for us to comment on her case or her health conditions.
In summary, surgery with implantable mesh is supported by multiple clinical research data
over a long history of clinical applications, has undergone rigorous regulatory reviews prior to
clinical distribution, and has been the preferred option for millions of women seeking to
improve their quality of life. Therefore, we firmly stand behind the clinical performance and
safety of our devices.
I hope this information is helpful to inform the facts of your story.
Regards,
Mindy Tinsley
Spokeswoman
Ethicon
ETHICON’S RESPONSE TO FOLLOW-UP QUESTIONS RE: HUMAN TESTING
Regarding human testing, thousands of patients who received TVT and TVT-O with the
same Prolene mesh used in TVT Secur participated in clinical studies that were published
and/or presented before the launch of TVT Secur. Prolene mesh, which is used in the TVT
devices, is the most commonly used treatment for stress urinary incontinence. Prolene mesh
has been adopted by the urogynecological community for its minimally invasive attributes,
efficacy and safety. In addition, prior to the launch of TVT Secur, the company performed
human cadaver labs, collected data on a small group of TVT Secur patients, and performed
an interim analysis on short term data from a subset of patients in a small prospective
single-arm clinical trial. While the interim analysis was not published, the five week results
from the full cohort of the prospective single-arm multicenter study were subsequently

 published and presented at the 2007 IUGA conference. (Karram M, et al. AN EVALUATION
OF THE GYNECARE TVT SECUR* SYSTEM (TENSION-FREE SUPPORT FOR
INCONTINENCE) FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. Int
Urogynecol J 2007; 18(Suppl1):S1–S24 (IUGA Abstract No. 004 at page S3).
As stated in our original response, Ethicon’s currently marketed pelvic mesh products are
not subject to any 522 orders. Because the TVT Secur product was decommercialized, it is
not subject to the 522 order listed on the FDA website, as the agency indicates in the Study
Design Description section.

Regards,
Mindy Tinsley
Spokeswoman
Ethicon