Anterior Vaginal Wall Prolapse Repair and the Rise and Fall of Transvaginal Mesh. Did We Come Full Circle? A Historical Perspective.

OBJECTIVE: To present a brief historical review of treatment options for pelvic organ prolapse with a focus on anterior vaginal wall defects and highlight changing practice patterns in the era of synthetic mesh controversy. METHODS: A MEDLINE and PubMed search was performed using the keywords pelvic organ prolapse, anterior colporrhaphy, and cystocele followed by a manual search of bibliographies. RESULTS: Ancient treatments included Hippocratic succession, local astringent, and use of pomegranates as crude pessaries. More sophisticated surgical techniques evolved in the 19th century with further refinement in the early 20th century. Numerous native tissue apposition techniques were popularized by Kelly, Kennedy, Burch, and Raz. Due to poor durability, surgeons sought alternate approaches including biologic and synthetic grafts. Synthetic transvaginal mesh (TVM) initially included use of Tantalum and Marlex to repair anterior wall defects. Both were eventually abandoned due to complications. TVM was re-designed, re-marketed, and re-introduced. Type 1 polypropylene monofilament TVM use became ubiquitous in female pelvic surgery peaking between 2004 and 2008. Initial promising outcomes were soon eclipsed by a surge of adverse events leading to multiple FDA warnings, reclassification to Class III, high-risk medical device, and ultimately a complete recall in 2019. CONCLUSION: The bidirectional pendulum swing on use of synthetic TVM has been occurring since its introduction 50 years ago. In the current era of mesh controversy, more practitioners are now revisiting previously described native tissue and biologic graft techniques. It appears that history has repeated itself.

Pure tissue repairs: a timely and critical revival.

"The majority of hernias can be satisfactorily repaired by using the tissues at hand. The use of mesh prosthesis should be restricted to those few hernias in which tension or lack of good fascial structures prevents a secure primary repair. This group includes large direct inguinal hernias and incisional hernias in which the defect is too large to close primarily without undue tension. Most recurrent hernias, because of this factor are best repaired with mesh prosthesis". These words, penned in 1960 by Francis Usher have reconfirmed what had been a mantra of the Shouldice Hospital (Usher in 81:847-854, 1960). The Shouldice Hospital has specialized in the treatment of abdominal wall hernias since 1945. It has, since its beginning, insisted on the fact that a thorough knowledge of anatomy coupled with large volumes of surgical cases would lead to unparalleled expertise. It was Cicero who taught us that "Practice, not intelligence or dexterity, will win the day"! Since the seminal contribution of Bassini (1844-1924), there have been no less than 80 procedures imitating his inguinal herniorrhaphy and much more since the introduction of mesh and mesh devices (Iason in Hernia. The Blakiston Company, Philadelphia, pp 475-604, 1940). All have failed to some extent and it appears that the common denominator for these failures was the inability to understand the importance of entering the preperitoneal space. Only Shouldice and McVay (Lotheissen, Narath) realized the shortcoming and have continued to thrive as a successful procedure. Entering the preperitoneal space eliminates any temptation to plicate the posterior inguinal wall, a layer normally deficient in direct inguinal hernias, but it also allows the identification of muscle layers rectus, transversus and internal oblique muscles which will go to reconstruct the posterior inguinal wall, without tension as reported by Schumpelick (Junge in 7(1):17-20, 2003).

Stoppa method - forgotten surgery.

Stoppa method - forgotten surgery.

Living history of medicine: vascular scaffolding, from dream to reality.

Following the launch of balloon angioplasty in 1977, its deficiencies-abrupt occlusion requiring emergency bypass surgery in one in twenty attempts and recurrence in one in three cases-became soon apparent. The attempts to eliminate the element of chance from this otherwise highly attractive technique resulted in the concept of intra-vascular scaffolding. Following the inception of self-expanding mesh stents made from stainless steel and extensive bench testing and animal experiments, the first clinical data were obtained in Switzerland almost 30 years ago in 1986 with promising, albeit not undisputed results. Technical improvements including potent platelet inhibitors have made the technique a cornerstone of catheter-treatment of vascular disease. This paper gives an account of the sometimes difficult beginnings of coronary and non-coronary stenting at the University of Lausanne in Switzerland.

Transvaginal mesh: a historical review and update of the current state of affairs in the United States.

INTRODUCTION: Transvaginal mesh usage has been at the forefront of popular media and academic debate for the past 10 years. Several US Food and Drug Administration (FDA) communications, society statements, and research articles have been written in an attempt to define and articulate the classification system, safety data, and efficacy of this approach to transvaginal surgery. In this review, we explore the history of transvaginal mesh surgery for pelvic organ prolapse (POP), review FDA and society statements, and research current practice in the United States. METHODS: We searched the English language literature using PubMed for articles related to safety and monitoring of transvaginal mesh and reviewed all FDA publication and notices and gynecology and urogynecology society statements on its use in the United States. We then reviewed 22 articles and grouped them into several sections. RESULTS: Mesh used to augment transvaginal repair of POP was introduced in the United States in 2005 without clinical safety and efficacy data. In the subsequent years of use, both major and minor complications were increasingly reported, leading to several FDA notifications and warnings. The type of mesh used, reporting and classifications systems, and provider usage has varied widely over time. CONCLUSION: We present a historical review of transvaginal mesh use for pelvic organ prolapse in the United States from 2005 to 2016. There continues to be heated debate among practitioners about balancing the efficacy of mesh use to decrease recurrent prolapse and complications. Research into safety and efficacy, along with tighter FDA regulations, is ongoing.

Made in Italy for hernia: the Italian history of groin hernia repair.

UNLABELLED: The history of groin hernia surgery is as long as the history of surgery. For many centuries doctors, anatomists and surgeons have been devoted to this pathology, afflicting the mankind throughout its evolution. Since ancient times the Italian contribution has been very important with many representative personalities. Authors, investigators and pioneers are really well represented. Every period (the classic period, the Middle Age, the Renaissance and the post-Renaissance) opened new perspectives for a better understanding. During the 18th century, more information about groin anatomy, mainly due to Antonio Scarpa, prepared the Bassini revolution. Edoardo Bassini developed the first modern anatomically based hernia repair. This procedure spread worldwide becoming the most performed surgical technique. After World War II synthetic meshes were introduced and a new era has begun for hernia repair, once again with the support of Italian surgeons, first of all Ermanno Trabucco. But Italian contribution extends also to educational, with the first national school for abdominal wall surgery starting in Rome, and to Italian participation and support in international scientific societies. Authors hereby wish to resume this long history highlighting the "made in Italy" for groin hernia surgery. KEY WORDS: Bassini, Groin hernia, History, Prosthetic repair.

Theodor Billroth's vision and Karl Ziegler's action: commemoration of the 40th day of death and the 50th anniversary of conferment of Nobel Prize for Chemistry of Karl Ziegler.

Alloplastic materials are broadly used in modern surgery. Until the middle of the 20th century, metal materials and especially silver were used because of their antimicrobial properties. With the development of a new catalytic process for the production of high-density polyethylene and polypropylene materials, a new era of prosthesis was introduced. These polymers are integral part of our everyday operations surgery, especially in hernia repair. The famous surgeon Billroth mentioned to his pupil Czerny in 1878: "If we could artificially produce tissues of the density and toughness of fascia and tendon, the secret of the radical cure of hernia would be discovered". The polypropylene developed by Karl Ziegler gave the surgeon a material for daily practice, which in its properties (nearly) achieved Billroth's initial vision. In 1963 the Nobel Prize for Chemistry was awarded to Karl Ziegler and Giulio Natta in Stockholm. Furthermore, August 11, 2013 will be the 40th anniversary of Karl Ziegler's death. This manuscript honors both days.

Davide Fieschi: a pioneer of plug repair in groin hernia surgery.

Plug repair actually represents one of most recommended procedures in open groin hernia repair. It is generally recognized that Lichtenstein in 1968 first introduced the plug technique for femoral and recurrent inguinal hernia. The present paper backdates more than 50 years the first application of a plug due to an ingenious Italian surgeon named Davide Fieschi.

Degradation, infection and heat effects on polypropylene mesh for pelvic implantation: what was known and when it was known.

Many properties of polypropylene mesh that are causative in producing the complications that our patients are experiencing were published in the literature prior to the marketing of most currently used mesh configurations and mesh kits. These factors were not sufficiently taken into account prior to the sale of these products for use in patients. This report indicates when this information was available to both mesh kit manufacturers and the Food and Drug Administration.

[The history of treatment of groin hernia]. / Rys historyczny leczenia chirurgicznego przepuklin.

Hernia (Greek kele/hernios--bud or offshoot) was present in the human history from its very beginning. The role of surgery was restricted to the treatment of huge umbilical and groin hernias and life-threatening incarcerated hernias. The treatment of groin hernia can be divided into five eras. The oldest epoch was ancient era from ancient Egypt to 15th century. The Egyptian Papirus of Ebers contains description of a hernia: swelling that comes out during coughing. Most essential knowledge concerning hernias in ancient times derives from Galen. This knowledge with minor modifications was valid during Middle Ages and eventually in the Renaissance the second era of hernia treatment began. Herniology flourished mainly due to many anatomical discoveries. In spite of many important discoveries from 18th to 19th century the treatment results were still unsatisfactory. Astley Cooper stated that no disease treated surgically involves from surgeon so broad knowledge and skills as hernia and its many variants. Introduction of anesthesia and antiseptic procedures constituted the beginning of modern hernia surgery known as era of hernia repair under tension (19th to middle 20th century). Three substantial rules were introduced to hernia repair technique: antiseptic and aseptic procedures. high ligation of hernia sac and narrowing of the internal inguinal ring. In spite of the progress the treatment results were poor. Recurrence rate during four years was ca. 100% and postoperative mortality gained even 7%. The treatment results were satisfactory after new surgical technique described by Bassini was implemented. Bassini introduced the next rule of hernia repair ie. reconstruction of the posterior wall of inguinal canal. The next landmark in inguinal hernia surgery was the method described by Canadian surgeon E. Shouldice. He proposed imbrication of the transverse fascia and strengthening of the posterior wall of inguinal canal by four layers of fasciae and aponeuroses of oblique muscles. These modifications decreased recurrence rate to 3%. The next epoch in the history of hernia surgery lasting to present days is referred to as era of tensionless hernia repair. The tension of sutured layers was reduced by incisions of the rectal abdominal muscle sheath or using of foreign materials. The turning point in hernia surgery was discovery of synthetic polymers by Carothers in 1935. The first tensionless technique described by Lichtenstein was based on strengthening of the posterior wall of inguinal canal with prosthetic material. Lichtenstein published the data on 1,000 operations with Marlex mesh without any recurrence in 5 years after surgery. Thus fifth rule of groin hernia repair was introduced--tensionless repair. Another treatment method was popularized by Rene Stoppa, who used Dacron mesh situated in preperitoneal space without fixing sutures. First such operation was performed in 1975, and reported recurrence rates were quite low (1.4%). The next type of repair procedure was sticking of a synthetic plug into inguinal canal. Lichtenstein in 1968 used Marlex mesh plug (in shape of a cigarette) in the treatment of inguinal and femoral hernias. The mesh was fixated with single sutures. The next step was introduction of a Prolene Hernia System which enabled repair of the tissue defect in three spaces: preperitoneal, above transverse fascia and inside inguinal canal. Laproscopic treatment of groin hernias began in 20th century. The first laparoscopic procedure was performed by P. Fletcher in 1979. In 1990 Schultz plugged inguinal canal with polypropylene mesh. Later such methods like TAPP and TEP were introduced. The disadvantages of laparoscopic approach were: high cost and risk connected with general anesthesia. In conclusion it may be stated that history of groin hernia repair evolved from life-saving procedures in case of incarcerated hernias to elective operations performed within the limits of 1 day surgery.

[A brief history of the inguinal hernia operation in adults]. / Een beknopte geschiedenis van de liesbreukoperatie bij volwassenen.

Late into the 19th century, treatment for inguinal hernias consisted of repositioning the hernia with trusses or using 'softening agents' such as warm herbal baths and moist bandages. Surgical resection or cauterisation, often combined with hemicastration, was only considered for cases ofstrangulated hernia that could not be repositioned. Bassini (1844-1924) is credited with developing the precursor to the modern inguinal hernia operation at the end of the 19th century. Bassini's essential discovery was that the transverse fascia plays a key role in the pathophysiology of inguinal hernias. Bassini's operation, consisting of complete incision of the transverse fascia and reconstruction of the inguinal floor, was considered the gold standard for nearly a century. One problem with the conventional Bassini operation was the tension applied to tissues, which led to a high rate of recurrence. Although Bassini's operation has now become obsolete, current surgical approaches still centre on fortification of the inguinal floor. This tension-free repair now uses synthetic mesh that is positioned using an open anterior approach, laparoscopic surgery, or a preperitoneal technique.

The contributions of Usher and others to the elimination of tension from groin herniorrhaphy.

Relaxing incisions (Wolfler 1892) were eventually shown (Read and McLeod, 1981) to reduce but not eliminate wound tension after sutured herniorrhaphy of the groin. Reinforcing prosthetics became widely shunned because of morbidity until Usher et al (1958) introduced polyethylene, then polypropylene mesh (1963) for preperitoneal tensionless repair of large defects. Excellent long-term results were obtained, with his technique, by Collier and Griswold (1967). Patt (1967) envisaged its application to primary hernia. Reis (1899) introduced early ambulation. However, it was not until Leithauser (1943), Blodgett (1946), and others showed immediate rising accelerated wound healing and reduced complications that Farquharson (1955) began outpatient hernioplasty (in 1950) under local anesthesia (Cushing 1900). Bellis (1964) followed, performing tensionless repair in 25%. Rodriguez and Phillips (1967) described office herniorrhaphy, 30% undergoing polypropylene mesh coverage without tension. Lichtenstein (1970) reported mesh onlay reinforcement for sutured repair of large defects, discharge was within 24 hours. Martin et al (1982) began (in 1972) to treat all inguinal herniation in adults with polypropylene mesh "to avoid recurrences". Newman did likewise, using tension-free placement (Rodriguez et al) in the subaponeurotic plane. Encountering resistance to publication ("real surgeons don't use mesh") he, in 1980, asked Lichtenstein to publish and popularize the technique. Kelly (1898) introduced plug prosthestic repair of femoral herniation. Drainer and Reid (1972) used polypropylene mesh from below under local anesthesia. Lichtenstein and Shore followed, treating recurrent inguinal defects similarly. Gilbert (1989) applied the technique to indirect herniae. Usher and others deserve recognition for their contributions to the elimination of tension from herniorrhaphy.

Milestones in the history of hernia surgery: prosthetic repair.

Billroth (1878) envisaged prostheses before Bassini's sutured cure (1887). Phelps (1894) reinforced with silver coils. Metals were replaced by plastic (Aquaviva 1944). Polypropylene (Usher 1962), resisting infection, became popular. Usher instituted tensionless, overlapping preperitoneal repair. Spermatic cord was parietalized, to obviate keyholing. Stoppa (1969) championed the sutureless Cheatle-Henry approach encasing the peritoneum. His technique, "La grande prosthese de renforcement du sac visceral" (GPRVS), was adopted by laparoscopists. Newman (1980) and Lichtenstein (1986) pioneered subaponeurotic positioning. Kelly (1898) inserted a plug into the femoral canal; Lichtenstein and Shore (1974) followed. Gilbert (1987) plugged the internal ring, and Robbins and Rutkow (1993) treated all groin herniae thus. Incisional herniation has been controlled by prefascial, retrorectus prosthetic placement (Rives-Flament 1973). ePTFE (Sher et al. 1980) is useful intraperitoneally, since it evokes few adhesions. Here, laparoscopy (Ger 1982) is competitive. Beginning in 1964 (Wirtschafter and Bentley), experimental and clinical studies have shown herniation may be associated with aging and genetic or acquired (smoking, etc.) systemic disease of connective tissue. These data, with prospective trials, all but mandate tensionless prosthetic repair.

Wrapping the visceral sac into a bilateral mesh prosthesis in groin hernia repair.

Almost 40 years of lucky existence is enough time for questioning and/or updating the Stoppa method for hernia repair. In this paper, the author reports the circumstances of the birth of this method more than 30 years ago, recalls its innovative principles, describes its technical aspects, and exposes its good results. Not simply approving old concepts, the author concludes with critical remarks with regard to a so-called political correctness of today's groin hernia repair, which gives great importance to reducing patient trauma arising from surgery. For belief without doubt can be wrong belief!

History of treatment of groin hernia.

The history of open surgery for groin hernia has gone through many stages of development, including the ancient era (ancient times to the fifteenth century), the era of the start of herniology (fifteenth to seventeenth centuries), the anatomic era (seventeenth to nineteenth centuries), the era of repair under tension (nineteenth to mid-twentieth century), and the era of tensionless repair (mid-twentieth century to the present). Five principles of modern hernia repair developed through these periods of development: antiseptic/aseptic hernia operation, high ligation of the sac, tightening of the internal ring, reconstruction of the posterior inguinal floor, and tensionless repair. Interestingly, many of the initial attempts at laparoscopic hernia repair did not adhere to the recognized principles of hernia surgery learned from open surgery. It is only when the transabdominal preperitoneal mesh repair and the totally extraperitoneal approach, which adhere to the basic principles, are considered that the results of laparoscopic hernia repair procedures can improve and the recurrence of hernia decrease.