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. 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.
Br J Ophthalmol. 2001 Feb;85(2):228-30.
Bacterial contamination of amniotic membrane.
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. 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), pterygium surgery or conjunctival replacement after removal of conjunctival lesions, and symblepharon removal and fornix reconstruction. It is often secured with sutures or with fibrin tissue adhesive.[13,14] The disadvantages of sutures include prolongation of surgical time, postoperative discomfort, and the risk of inflammation or infection 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, chemical injury of the cornea and conjunctiva, fornix reconstruction, toxic epidermal necrolysis (TEN), and Stevens-Johnson syndrome (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. 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: