Prolapse Repair Mesh

What is Prolapse Repair Mesh?

Prolapse Repair Mesh is a class III medical device that is designed to reinforce a weakened vaginal wall. The mesh graft is composed of synthetic or biopolymers and is a screen-like material used as reinforcement for tissue or bone.

Prolapse Repair Mesh Inside the Vaginal Wall [1]

Medical Disorder Treated Using Prolapse Repair Mesh

• Pelvic Organ Prolapse (POP
  • Pelvic organ prolapse is caused when pelvic organs drop from their normal position because the tissue and muscles of the pelvic floor can no longer support the organs. The pelvic organs include the bladder, uterus and cervix, vagina, and rectum.
  • There are 5 different types of POP; Cytocele, Enerocele, Rectocele, and Vaginal vault prolapse, and Uterine prolapse
  • The most common types of POP are Cystocele: when the bladder drops into or out of the vagina; uterine prolapse when the uterus bulges into or out of the vagina; enterocele where part of the small intestine bulge into the vagina. 
    

    

    Visual comparison a body with and without pelvic organ prolapse.  [2]

How Common is Pelvic Organ Prolapse & What Causes It?

• POP  affects women and it affects older women more than younger women. It affects 3% of women in the U.S. every year.
• Majority of women suffering from POP fall into one of the categories in the below graphic:

Causes of POP [3]

FDA Regulations

Prolapse Repair mesh has been BANNED in the U.S. by the FDA for pelvic organ prolapse (POP) as of 2019. Recently, the FDA ordered manufacturers to stop distributing and selling POP mesh because they had not proven its safety or effectiveness. On April 16th, the FDA released an article stating “the U.S. Food and Drug Administration today ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to stop selling and distributing their products in the U.S. immediately. The order is the latest in a series of escalating safety actions related to protecting the health of the thousands of women each year who undergo surgery transvaginally to repair POP.” [4]

The FDA has posted a list of steps on their website detailing what you should do if you have previously undergone transvaginal repair surgery using prolapse repair mesh. The recommendations are listed below:

• “Continue with your annual and other routine check-ups and follow-up care. There is no need to take additional action if you are satisfied with your surgery and are not having complications or symptoms.”
• Notify your health care provider if you have complications or symptoms develop, such as persistent vaginal bleeding or discharge, pelvic or groin pain, or pain during sexual intercourse.
• Let your health care provider know you have surgical mesh, especially if you plan to have another surgery or other medical procedures.
• Talk to your health care provider about any questions you may have.
• Submit a voluntary report about any problems experienced with surgical mesh for repair of pelvic organ prolapse through Medwatch, the FDA Safety Information and Adverse Event Reporting program.” [5]

Alternative Treatments

Surgery

Surgery may be performed, your own body tissue to repair the prolapse,. A colpocleisis surgery can also be performed to close the vaginal opening. It is usually recommended for women do not plan on having vaginal intercourse.

Pessary 

A pessary is a removable device inserted into the vagina to support the pelvic organs. They come in different shapes and sizes. Pessaries are made from medical-grade silicone or latex rubber.

Pelvic floor muscle therapy

Pelvic floor exercises may be advised based on the severity of the symptoms. They would help strengthen the pelvic floor muscles. The exercises include conscious contractions, electrical stimulation or via biofeedback training.

Diet changes

A high fiber diet may be recommended to prevent constipation and lessen constipation during bowel movements.

Components & Structure of Prolapse Repair Mesh

Non-Absorbable Synthetic

The synthetic mesh can either be absorbable or non-absorbable or a combination of the two depending on the application. Non-absorbable meshes remain in the body indefinitely and are considered a permanent reinforcement for the type of repair. These implants have a lower rate of infection. The most popular synthetic meshes are either made from polypropylene and polyester.

Absorbable Synthetic

The body absorbs this type of mesh while tissue grows at the site. This helps the ligaments in the pelvis strengthen.

Biologic

Animal tissue derived mesh is made from the tissues of animal intestine, or skin (pig or cow). They have been processed and disinfected to be compatible as an implant. Animal-derived mesh is absorbable and degrade over time.

Composite

Any combination of the above

Structure

Structurally, the synthetic mesh is either a knitted mesh or woven, allowing for the mesh to have conformity when supporting the repair of prolapsed tissues. The preferred structure of these meshes is a knitted structure as it creates a more porous and conformable/flexible structure when compared to woven meshes. The synthetic nature allows the mesh to be durable. The mesh is also lightweight and resists tear due to loop formation of the knitting process. [6]

Implantation Procedure

Sterilization

Surgical implant sterilization for synthetic plastic implants require low-temperature sterilization techniques.

Ozone

Ozone is generated from USP grade oxygen, steam quality water and electricity to destroy microorganisms as a powerful oxidant yet highly unstable.  Sterilization by the ozone process is compatible with a range of medical textile used materials including silicone, PVC, teflon, polypropylene, polyethylene, and acrylic.

Gas Plasma

Sterilization of plastics via hydrogen peroxide gas plasma is used since a lot cannot tolerate extreme temperatures and humidity without degrading. Hydrogen peroxide gas plasma uses the combined use of hydrogen peroxide gas and creation of free radicals to “inactivate” microorganisms.

Ionizing Radiation

Sterilization by ionizing radiation has been used for a number of different medical devices. This radiation produced by cobalt 60 gamma rays or electron accelerators..  Is best used for large scale sterilization.

Insertion

Insertion of prolapse repair mesh is a minimally invasive surgery done by making a small incision in the abdomen or laparoscopically (small incisions near the navel and using a camera) and inserting the mesh to support organs.

Step by step Abdominal Sacrocolpopexy [8]

Issues with Prolapse Repair Mesh

• Recurrence of POP
• Pelvic pain and difficulty moving
• Abdominal pressure
• Vaginal bleeding
• Urinary incontinence
• Vagina scarring or shortening
• Vaginal discharge and infections
• Perforation of pelvic organs, bowels and blood vessels
• Erosion, and possible exposure or extrusion, of mesh through vaginal tissue [9]

Advantages & Disadvantages

Advantages	Disadvantages
High efficiency	Vaginal mesh erosion
Durable	Vaginal mesh contraction
Better organ stabilizer	May cause pain during sexual intercourse, urinary problems, infections, tearing of organs, and bleeding
	High chance of recurring POP
	Requires multiple surgeries
	Complex procedure
	Caused many lawsuits
	Banned by the FDA

Relevant Studies

• FDA study: Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse
  •  Study consisting of evaluating data from the FDA’s Manufacturer and User Device Experience (MAUDE) database to determine the safety and effectiveness of transvaginal mesh for POP
  • Released in July 2011 and based on data from January 1st, 2008 to December 28th, 2010
  • The conclusions of this study were that “the FDA determined that (1) serious adverse events are NOT rare, contrary to what was stated in the 2008 PHN, and (2) transvaginally placed mesh in POP repair does NOT conclusively improve clinical outcomes over traditional non-mesh repair.” [10]
• Safety and Effectiveness of Transvaginal Mesh Placement in Treating Pelvic Organ Prolapse
  • Study conducted from May 2014 to June 2017 to observe the clinical effect and complications of transvaginal mesh (TVM) placement on treating pelvic organ prolapse (POP) [11]
• Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process [12]
  • Study published in 2017 challenging the initial licensing transvaginal mesh products in the 1990’s
• Recent Advances in Pelvic Floor Repair [13]
  • Study conducted to outline the alternative methods for treating POP without using prolapse repair mesh
  • Includes comparisons between recent advances and traditional prolapse repair mesh
  • Concludes that the recent advances are far more effective and safer than prolapse repair mesh

Top Manufacturers and Brands

• • Johnson & Johnson (Ethicon) produced 4 different prolapse repair mesh products; the Gynecare Prosima Pelvic Floor Repair System, the Gynecare Prolift Kit, the Gynecare TVT Secur, and the Gynecare Prolift + M Kit.

Johnson & Johnson’s Gynecare Prolift Repair Mesh [14]

• All of these products have been discontinued. In January of 2020, a court ruling declared that Johnson & Johnson was to pay $344 million because the company deceptively marketed transvaginal pelvic mesh implants after the FDA declared these products banned in 2019.

• 

  Graphic from Johnson & Johnson’s Announcement Regarding the Discontinuation of their prolapse repair mesh in the NY Time [15]

• C.R. Bard manufactured 5 different prolapse repair meshes; Avaulta Solo, Avaulta Plus, Align Urethral Support System, Pelvilace Support Systems, and Uretex Urethral Support Systems.
• Endo (American Medical Systems) had 6 different prolapse repair meshes in the product catalogue; Perigee, InteXen, IntePro, MiniArc Slings, BioArc Slings, and Monarc Slings.
• Boston Scientific produced 4 prolapse repair meshes; Pinnacle Pelvic Floor Repair Kit, Uphold Vaginal Support System, Advantage, and Obtryx Slings.
• Coloplast manufactured 4 prolapse repair meshes; Minitape, Aris Transobturator Sling, Omnisure, and Novasilk Sling. [16]

Business Strategy

It is difficult to define the business strategy for prolapse repair mesh in the U.S. and the U.K as the product is no longer manufactured and sold in these countries. The information regarding the current business strategy for this product in other countries is limited. The companies that previously manufactured prolapse repair mesh are continuing to produce medical products and promote alternative methods of treating POP.

Though prolapse repair mesh was banned, the market for prolapse repair devices is continuing to grow every year. Below is data detailing the previous market for Prolapse Repair product in 2018:

Global POP Repair Device Sales Market Forecast Report from 2018 [17]

Projection for the growth of the POP Repair market for the next 7 years [18]

References

[1] Beyerstein, L., & Beyerstein, L. (n.d.). A Female Surgical Nightmare. Retrieved from http://inthesetimes.com/article/13353/a_female_surgical_nightmare

[2] Pelvic Guru. “Pelvic Floor, Prolapse, and Transvaginal Mesh Complications. What’s the Connection?: Pelvic Guru Incontinence Surgery, Kegels, Mesh, Mesh Complications, Mesh Lawsuits, Pelvic Floor Physical Therapy, Pelvic Floor Strengthening, Pelvic Muscle Strengthening, Pelvic Organ Prolapse, Pelvic Physical Therapy, Pelvic Prolapse, Pelvic Therapy, POP, Prolapse, Stress Urinary Incontinence, SUI, Transvaginal Mesh, Urinary Leakage, Vaginal Mesh.” Pelvic Guru, June 6, 2019. https://pelvicguru.com/2012/08/22/pelvic-floor-prolapse-and-transvaginal-mesh-complications-whats-the-connection/.

[3] Pelvic Organ Prolapse – Types, Causes, Symptoms, Diagnosis, Treatment & Prevention. (n.d.). Retrieved from https://www.medindia.net/patientinfo/pelvic-organ-prolapse.htm

[4] FDA (2019, April 16). FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices. Retrieved April 21, 2020, from https://www.fda.gov/news-events/press-announcements/fda-takes-action-protect-womens-health-orders-manufacturers-surgical-mesh-intended-transvaginal

[5] Center for Devices and Radiological Health. “Pelvic Organ Prolapse (POP).” U.S. Food and Drug Administration. FDA. Accessed April 21, 2020. https://www.fda.gov/medical-devices/urogynecologic-surgical-mesh-implants/pelvic-organ-prolapse-pop.

[6] Liang, R., Knight, K., Abramowitch, S., & Moalli, P. A. (2016, October). Exploring the basic science of prolapse meshes. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5161092/

[7] Transvaginal Mesh Implants – Bladder Sling, Hernia Repair, Mesh Tape. (2018, September 27). Retrieved from https://thesandersfirm.com/transvaginal-mesh-overview/transvaginal-mesh-implant-types/

[8] Gaston, R., & Ramsden, A. (2011, January 25). Laparoscopic sacrocolpopexy. Retrieved from https://bjui-journals.onlinelibrary.wiley.com/doi/pdf/10.1111/j.1464-410X.2010.10080.x

[9] Llamas, Michelle. “Complications of Transvaginal Mesh for Pelvic Organ Prolapse.” Drugwatch.com, February 27, 2020. https://www.drugwatch.com/transvaginal-mesh/complications-and-problems/.

[10] FDA, and CDRH. “Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse ,” July 2011.

[11] Zhu, Haitao, Zeyu Chen, and Wensheng Du. “Safety and Effectiveness of Transvaginal Mesh Placement in Treating Pelvic Organ Prolapse,” November 13, 2019. https://doi.org/10.21203/rs.2.17251/v1.

[12] Heneghan, C. J., Goldacre, B., Onakpoya, I., Aronson, J. K., Jefferson, T., Pluddemann, A., & Mahtani, K. R. (2017, December 1). Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process. Retrieved from https://bmjopen.bmj.com/content/7/12/e017125

[13] Mironska, E., Chapple, C., & MacNeil, S. (2019). Recent advances in pelvic floor repair. F1000Research, 8, F1000 Faculty Rev-778. https://doi.org/10.12688/f1000research.15046.1

[14] Akre, J., Link, G., Akre, J., Caitlyn, Ruth, Caitlyn, … J&j. (2012, June 5). Four J&J Vaginal Meshes Named – Will Be Removed from Market. Retrieved from https://www.meshmedicaldevicenewsdesk.com/four-jj-vaginal-meshes-named-will-be-removed-from-market/

[15] Wang, S. S. (2014, March 13). Doctors, Device Makers: Close Ties. Retrieved from https://www.wsj.com/articles/doctors-device-makers-close-ties-1394751937

[16] Llamas, Michelle. “Transvaginal Mesh: What Is Transvaginal Mesh Used For?” Drugwatch.com, February 27, 2020. https://www.drugwatch.com/transvaginal-mesh/.

[17] Liang, R., Knight, K., Abramowitch, S., & Moalli, P. A. (2016, October). Exploring the basic science of prolapse meshes. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5161092/

[18] Reports and Data, https://www.reportsanddata.com/. (n.d.). Pelvic Organ Prolapse Repair Market Growth, 2019-2027. Retrieved from https://www.reportsanddata.com/report-detail/pelvic-organ-prolapse-repair-market