Johnson & Johnson Medical Pty Ltd Submission to the Senate Community Affairs Committee: Number of women in Australia who have had transvaginal mesh implants and related matters May 2017 1 Our Credo We believe our first responsibility is to the doctors, nurses and patients, to mothers and fathers and all others who use our products and services. In meeting their needs everything we do must be of high quality. We must constantly strive to reduce our costs in order to maintain reasonable prices. Customers’ orders must be serviced promptly and accurately. Our suppliers and distributors must have an opportunity to make a fair profit. We are responsible to our employees, the men and women who work with us throughout the world. Everyone must be considered as an individual. We must respect their dignity and recognise their merit. They must have a sense of security in their jobs. Compensation must be fair and adequate, and working conditions clean, orderly and safe. We must be mindful of ways to help our employees fulfil their family responsibilities. Employees must feel free to make suggestions and complaints. There must be equal opportunity for employment, development and advancement for those qualified. We must provide competent management, and their actions must be just and ethical. We are responsible to the communities in which we live and work and to the world community as well. We must be good citizens - support good works and charities and bear our fair share of taxes. We must encourage civic improvements and better health and education. We must maintain in good order the property we are privileged to use, protecting the environment and natural resources. Our final responsibility is to our stockholders. Business must make a sound profit. We must experiment with new ideas. Research must be carried on, innovative programs developed and mistakes paid for. New equipment must be purchased, new facilities provided and new products launched. Reserves must be created to provide for adverse times. When we operate according to these principles, the stockholders should realize a fair return. 2 Introductory comments Johnson & Johnson Medical Pty Ltd (JJM) appreciates the opportunity to contribute to the inquiry into transvaginal mesh implants in Australia. JJM provides a range of innovative medical devices and solutions used primarily by healthcare professionals in the fields of orthopaedics, neurological disease, surgery and surgical instruments, diabetes, infection prevention, diagnostics, cardiovascular disease, and aesthetics. We are the largest medical technology provider in Australia working across public and private sectors. We empathise with all women suffering from stress urinary incontinence and pelvic organ prolapse, conditions that can be serious and debilitating, and we are always concerned when a patient believes they have experienced an unexpected or undesirable outcome. While treatment options with varying degrees of efficacy exist for these conditions, surgical treatment for stress urinary incontinence and pelvic organ prolapse remains an important option. The use of implantable mesh is supported by clinical research and is often the preferred option to treat certain female pelvic conditions, including stress urinary incontinence and pelvic organ prolapse. There is presently a representative action in the Federal Court that has been brought against JJM and two affiliated companies. The Federal Court has allocated 24 weeks to hear the matter, commencing on 4 July 2017. The factual and legal issues raised in those proceedings are comprehensive and complex. Some 35 national and international experts across a range of medical and scientific disciplines are expected to give evidence at trial. A number of the matters and issues which this Committee will consider and report upon through this Inquiry directly relate to matters and issues that will be fully heard and determined by the Federal Court in those proceedings. While JJM respects the decision of the applicants (and the group members they represent) to bring legal proceedings such as these, JJM is defending the claims that have been made and will continue to do so. Having regard to the jurisdiction of the Federal Court and its powers in relation to both the proceedings and the litigants (and the imminent commencement of that matter), JJM will not make submissions on matters regarding the specific issues in contention in the litigation. While we recognise that the Senate has an important role to play in exploring issues that impact the Australian community and constituencies, the Federal Court is the forum chosen by the applicants to hear and determine these matters and we respect that decision. To assist the Committee, we have provided background to the conditions treated by mesh medical devices and some history of the development of those medical devices. We have also provided submissions in response to the Terms of Reference (to the extent possible, having regard to the Federal Court litigation). 3 Background to the conditions and medical devices Pelvic mesh medical devices were developed in conjunction with surgeons seeking to address the shortcomings of other treatment options for stress urinary incontinence and pelvic organ prolapse, and they have helped a significant number of women worldwide suffering from these conditions. While the terms of reference refer to “transvaginal mesh”, this term requires some definition and explanation to understand the medical conditions being treated and the devices that are treatment options. As we interpret the terms of reference, the Committee is concerned with mesh medical devices used to treat two separate and distinct medical conditions – stress urinary incontinence and pelvic organ prolapse. While medical devices comprising polypropylene mesh (in various forms and structures) are an option used to surgically treat the conditions, the surgical approach to implantation may vary – such that surgery may be conducted where the devices are implanted in one of two ways depending on surgeon choice. Implantation may be accomplished through an incision in the vaginal wall (that is, a “transvaginal” implantation) or through an incision in the abdomen (that is, either a “laparoscopic” or an “open” (laparotomy) implantation). JJM was the sponsor and distributor of a number of medical devices which can be used to treat stress urinary incontinence and pelvic organ prolapse, and those devices were (at various times) indicated for use using a transvaginal surgical technique. In broad terms, JJM supplied a family of medical devices known as “TVT” to the Australian market for stress urinary incontinence, and “Gynemesh PS”, “Prolift”, "Prolift+M" and “Prosima” branded medical devices to the Australian market for the treatment of pelvic organ prolapse. The TVT medical devices were first supplied in Europe pursuant to CE marking (that is, compliance with European Directive 93/68/EEC) in 1997, were cleared by the US Food and Drug Administration in 1998 and supplied in Australia in 1999 (in compliance with Australian regulations at the time). The Gynemesh PS, Prolift, Prolift+M and Prosima medical devices were also supplied in Europe and the US (in compliance with their regulations) before supply in Australia (again, in compliance with Australian regulations) in 2003, 2005, 2009 and 2010 respectively. Where we refer in this submission to JJM “tape” devices, we are referring to the TVT medical devices used for the treatment of stress urinary incontinence and where we refer to JJM “mesh” devices, we are referring to Gynemesh PS, Prolift, Prolift+M and Prosima medical devices used for the treatment of pelvic organ prolapse. Stress urinary incontinence Stress urinary incontinence (SUI) is an increasingly prevalent condition among women and has an adverse impact on health-related quality of life. Although estimates vary, a recent population study estimated the prevalence of SUI in women to be 26 %, with prevalence of SUI increasing with age.1 Estimates indicate that the number of procedures for SUI may increase by approximately 50% from 210,700 in 2010 to 310,050 by 2050.2 1 Reynolds WS, Dmochowski RR, Penson DF. Epidemiology of stress urinary incontinence in women. Curr Urol Rep. 2011;12(5): 370-6. 2 Wu JM et aL Predicting the number of women who will undergo incontinence and prolapse surgery, 2010 to 2050. AFT1 J Obstet GynecoL 2011;205(3):230 el-5 4 The current gold standard for surgical management of SUI is the synthetic mid-urethral sling.3 Since its introduction in 1995, the synthetic midurethral sling has increasingly become the preferred surgical treatment for SUI, with a resultant decrease in autologous slings, laparoscopic or open Burch colposuspensions, and collagen injections.4 The discovery of tension-free vaginal tape (TVT) began in 1986 with two unrelated observations: pressure applied unilaterally at the mid-urethra controlled urine loss on coughing; and implanted Teflon tape caused a collagenous tissue reaction. This led to a paradigm shift of understanding of the mechanism of stress incontinence. The theory was put into practice by a team led by Professor Ulf Ulmsten by developing a new minimally invasive, ambulatory, standardized surgical procedure to be named tension-free vaginal tape (TVT) at the time of its launch in Europe at the end of 1997, in the USA at the end of 1998 and in Australia at the end of 1999. Several modifications of the procedure were tested using Gore-Tex, Mersilene and Nylon meshes before arriving at the final one, which included the use of Ethicon's monofilament polypropylene Prolene tape. Gore-Tex, Mersilene and Nylon meshes had complication rates that were higher than Prolene polypropylene mesh. Once the TVT procedure was finalized the first prospective clinical trial was conducted at the Department of Obstetrics and Gynecology of the University Hospital of Uppsala, Sweden, of which Professor Ulmsten was the chairman. The trial included 75 primary cases of stress urinary incontinence that were followed for 24 months. The results, published in 1996, were very encouraging and prompted further prospective clinical trials conducted in normal clinical settings.