Danger of Prokera and Amniotic Membrane

Danger of Prokera and Amniotic Membrane
Rarely a patient will come in to see us who need urgent treatment for a chemical burn and is scared to use Amniotic Membrane for healiing. This recently happened in a patient who had a severe alkaline burn of the cornea. It was tough to see him refuse the treatment over fear of the Amniotic Membrane expressed by his family members. They did not want to believe our experience of this sight-saving treatment. He continues to heal slowly with an increased risk of permanent corneal scaring not only centrally, which can sometime lead to the need for a corneal transplant, but also to the limbal stem cells, which can lead to chronic dry eye, pain, foreign body sensation.
So here below is compiled all the risks and dangers of using Amniotic Membrane and Prokera.
A Pubmed search (which includes all published reports in the US & even abroad) revealed the search below at the end of this blog post.

The vast majority show the significant benefit of using Amniotic Membrane or Prokera in a variety of corneal issues:

For example, in a study conducted in Italy with 12 years of follow-up, 5,349 surgical procedures were successfully performed using amniotic membrane patches.1 Conditions treated were corneal ulcers including neurotrophic keratitis (2,430); keratitis/endophthalmitis (363); pterygium (343); post-keratoplasty, glaucoma or cataract (339); chemical trauma (332); bullous keratopathy (265); neoplasm of the ocular surface (239); reconstruction of the conjunctiva and fornix (154); corneal degeneration (123); recurrent epithelial erosion (109); primary and secondary limbal stem cell deficiency (78); mucous membrane pemphigoid (59); dystrophy (58); mechanical trauma (25); chronic Stevens-Johnson syndrome or Lyell’s syndrome (20); reconstruction of the anophthalmic cavity (17); physical trauma (16); eyelid reconstruction (11); dysfunctional tear syndrome (9); and other (359).
See references below.
The only paper showing any concern, is the paper below showing a greater risk of bacterial contamination of amniotic membrane in placentas obtained from vaginal births compared to C-sections.
However, all the Amniotic Membrane we use if from C-sections. 
In all my years at Harvard and private practice, I have never seen an infection with any Amniotic Membrane: even when we were harvesting it from MGH with Dr. Stephen Foster at MEEI. 
If I had a chemical burn in my eye, I would run to get an Amniotic Membrane placed asap.
Amniotic Membrane is meant to help heal infections faster and that is what I have seen in hundreds of patients.

Sandra Lora Cremers, MD, FACS
Here is a quick video showing the sight saving effect of Amniotic Membrane. I will post a video soon on how to insert a Prokera as it is very easy and minimally uncomfortable. 
This paper below should never scare someone about amniotic membrane as we do not use placenta from vaginal deliveries in the US to the best of my knowledge with any company: definitely not with Prokera.
 2001 Feb;85(2):228-30.

Bacterial contamination of amniotic membrane.



In the light of interest being shown in amniotic membrane grafts for use in ocular surgery, this study aims to identify the bacterial contaminants commonly found on placental membranes from both caesarean and vaginal deliveries.


Samples of placental membrane were taken following both elective caesarean and normal vaginal deliveries. Bacterial contaminants were identified.


All samples were contaminated. A greater number of different species were recovered from the vaginal deliveries, including several which were actually or potentially pathogenic.


There is a greater risk of contamination from pathogenic bacteria on placentas from vaginal deliveries. It is recommended that amnion for use in ocular surface procedures should be retrieved only from placentas following elective caesarean deliveries.
Here is a great review article by Kunal Suri, M.D.; Mustafa Kosker, M.D.; Irving M. Raber, M.D.; Kristin M. Hammersmith, M.D.; Parveen K. Nagra, M.D.; Brandon D. Ayres, M.D.; Colleen P. Halfpenny, M.D.; Christopher J. Rapuano, M.D
Amniotic membrane has been used widely in the treatment of ocular surface disease since early 1990s.[1] The usefulness of amniotic membrane has been attributed to its anti-inflammatory, anti-fibrotic, anti-vascularization, and anti-scarring effects and also to its ability to enhance epithelial healing. Indications for its use include a broad spectrum of ocular surface disorders, such as limbal stem cell deficiency (LSCD),[2,3] corneal ulcers of different etiologies,[4–6] chemical and thermal burns of the cornea,[7,8]persistent epithelial defects (PEDs),[9] pterygium surgery[10] or conjunctival replacement after removal of conjunctival lesions,[11] and symblepharon removal and fornix reconstruction.[12] It is often secured with sutures or with fibrin tissue adhesive.[13,14] The disadvantages of sutures include prolongation of surgical time,[13] postoperative discomfort,[13] and the risk of inflammation[15] or infection[16] associated with them.
ProKera (Bio-Tissue, Inc., Doral, FL) is a cryopreserved amniotic membrane, clipped to a dual polycarbonate ring system that was approved by U.S. Food and Drug Administration in 2003. It acts as a biological bandage with the stromal side in contact with the cornea. The polycarbonate ring is similar to a symblepharon ring with an inner diameter of 16 mm and an outer diameter of 21 mm. ProKera is placed in the eye in a similar fashion to a large contact lens. Compared with surgical application of amniotic membrane, the ProKera device obviates the need of an operating room and is therefore an easier, less time-consuming and less costly process that can be performed readily in the office.
There are a few case reports and case series in the literature regarding the use of ProKera in bacterial keratitis,[17] chemical injury of the cornea and conjunctiva,[18] fornix reconstruction,[19] toxic epidermal necrolysis (TEN),[20] and Stevens-Johnson syndrome[21] (Table 1). The largest reported series consists of 21 eyes of 20 patients, in whom ProKera was inserted for a variety of ocular surface and orbital disorders.[22] We report our larger experience with this sutureless amniotic membrane device to treat various ocular surface disorders

This is from the company most eyeMDs in the US use:


What is PROKERA®?

PROKERA® is a therapeutic device used by eye doctors around the world to protect, repair and heal damaged eye surfaces. PROKERA® is made by clipping a piece of amniotic membrane tissue in between two rings made out of a clear, flexible material.

What is amniotic membrane tissue?

Amniotic membrane is part of the placenta and is the tissue closest to the baby throughout development in the womb. Amniotic membrane protects the baby from any harm and has natural therapeutic actions which help the baby develop. The tissue has healing properties that aid in ocular surface repair.

What does PROKERA® do?

The amniotic membrane tissue in PROKERA® has natural therapeutic actions that help damaged eye surfaces heal. Eyes treated with PROKERA® have quicker healing, less pain, less scarring, and less inflammation. The amniotic membrane in PROKERA® is thin and clear like the tissue on the surface of your eye and protects your eye’s damaged tissue while inserted. 

What does PROKERA® treat?

PROKERA® is used by eye doctors to treat eye diseases such as keratitis, corneal scars, chemical burns, corneal defects, partial limbal stem cell deficiency and many other ocular surface diseases with inflammation. 

Is PROKERA® safe?

PROKERA® is a safe, effective treatment provided by a tissue bank regulated by the FDA. The tissue has passed many quality control tests before it is provided to your doctor. Ask your doctor if you are concerned about the risks involved with using a human tissue.

Tissue Safety and Quality Assurance

The products offered by  Bio-Tissue® (PROKERA®AmnioGraft®, & AmnioGuard®) are cryopreserved human Amniotic Membrane. They are designated as Human Cell, Tissue, and Cellular and Tissue-Based Products (HCT/P) by the U.S. Food and Drug Administration (FDA), minimally manipulated and are produced in accordance with the FDA regulations for Good Tissue Practices (21 CFR 1270, 1271).
Live, healthy mothers may be considered eligible for placental donor status following elective Cesarean Section delivery. These mothers provide full informed consent and are put through extensive social habit screening, medical history and records review for infectious, malignant, neurological, auto-immune, transmissible diseases, and independent, serological CLIA lab testing (using FDA licensed test kits) which are non-reactive (negative) for the following tests:
  • HIV 1 & HIV 2, Antibody
  • HIV 1 Virus (NAT)
  • Hepatitis B surface antigen (HBsAg)
  • Hepatitis B core antibody (HBcAb)
  • Hepatitis C Antibody (HCVAb)
  • Hepatitis C Virus (NAT)
  • HTLV 1 & 2 antibodies
  • Syphilis (RPR)
  • Additional testing may include: West Nile Virus, WNV, (NAT)
  • Additional testing may include: Chagas (T. Cruzi)
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