Seri Surgical Scaffold has gained popularity in the medical world as an innovative silk netting used to stimulate tissue regrowth, but the U.S. Food and Drug Administration has also had the scaffold on its radar for improper marketing and contaminated packaging that put users at risk of serious complications.
Seri Surgical Scaffold is a silk netting often used in plastic surgery. The mesh serves as a base for the body to regenerate tissue. This growth strengthens stretched and weakened skin, which is why the material is commonly used in breast reconstruction and body contouring surgeries. The Seri Scaffold is unique because it’s made from bioengineered silk and is bioresorbable, meaning as the tissue regenerates, the netting dissolves into the body. Eventually, the scaffold is completely dissolved and only tissue remains in its place.
The netting is made from purified silk proteins sourced from the Bombyx mori silkworm. The silk fibers are knitted into a lattice shape to construct the scaffold. The sterile product looks similar to a silk screen and can be cut into many shapes and sizes for surgical use without tearing or fraying. Because of its flexibility, Seri Scaffold can also be used in laparoscopic surgeries and easily fits into laparoscopic tools.
In surgery, doctors place the scaffold over the area that needs support, such as the bottom and side of the breast in breast reconstruction surgeries. The surgeon places stitches in the scaffold to ensure it stays in place. While in place, the scaffold reinforces and strengthens the soft tissue. As the soft tissue repairs itself post-surgery, it also absorbs the silk over time. By the end of the two-year process, the scaffold will be mostly or entirely replaced with regrown soft tissue.
Serica Technologies originally created the scaffold in the mid-2000s. In 2010, Allergan Inc. acquired Serica and its scaffold technology. Both patients and surgeons reported high levels of satisfaction and minimal complications in clinical trials. However, packaging defects have also led to contaminated scaffold and serious complications.
Seri Scaffold Complications and Side Effects
Clinical trials show Seri Surgical Scaffold patients rarely experience complications. One trial studied 139 patients from 2013 to 2015. The results recorded six different complications a minimal number of patients experienced. The trial investigators didn’t attribute any of the complications to the scaffold technology.
The clinical trial complications were:
- Tissue death, 6.7 percent
- Seroma, or fluid buildup, 5.7 percent
- Hematoma, 4.8 percent
- Implant loss, 3.8 percent
- Capsular contracture, or scar tissue that causes the breast implant to harden, 1.9 percent
- Breast infection, 1 percent
The official Seri Surgical Scaffold paperwork from Allergan, the manufacturer, lists five adverse reactions a patient may experience. All of the complications are consistent with most implantable materials. The possible complications are:
- Adhesion formation
- Fistula formation
The scaffold is made of silk, so those with a silk allergy may also experience some side effects, including swelling and redness. People with a known silk allergy are not recommended to use Seri Scaffold.
In January 2013, the U.S. Food and Drug Administration issued a recall on all Seri Scaffold because of an increased report of complications. The product is prepared in dual packaging and, according to the recall, a seal on the outer pouch was not maintained on some products. As a result of the packaging process error, the sterility of the scaffold may have been compromised. It’s more likely a patient will experience one of the expected side effects if the scaffold was not properly sterilized before it was implanted.
Diagnosing and Treating Complications
In addition to the possible complications patients may experience because of Seri Scaffold, surgery also carries many risks and possible complications. If patients develop any complications following surgeries, it’s best to consult their surgeon right away. The surgeon may be able to identify if the scaffold is the cause of the complication or not and devise a treatment plan.
Treatment of Seri Scaffold complications varies based on the complication, and is therefore up to the doctor’s discretion. Treatments may vary from administering antibiotics if a patient experiences infection, to removing the scaffold if the patient has a silk allergy.
In one case reported to the FDA in 2012, the patient experienced an infection, fever, seroma, extrusion, inflammation and pain in the breast. The patient was taken to the emergency room and admitted for a longer stay at the hospital. She was treated with the removal of the scaffold and a new drain placement.
Seri Scaffold vs. Other Surgical Scaffolds
Seri Scaffold is the first surgical scaffold of its kind, made from bioengineered silk rather than plastic or other organic materials. Other popular organic materials include dermis matrix products that use collagen from human cadavers and pigs. These products are typically thinner, are stretchier and dissolve quicker than Seri Scaffold. The Seri product takes roughly two years to fully dissolve in the body.
Plastic surgical meshes may also be used in reconstructive surgeries. Unlike organic meshes, plastic mesh does not bioresorb and is a permanent addition to the body. Plastic surgical mesh is also linked to many complications, including extrusion, pain, infection, bleeding and organ perforation. Complication occurrence rates are high, and caused the death of four patients between 2008 to 2010.
There are three situations in which Seri Scaffold is not recommended for use. People with silk allergies will experience allergic reactions to the implant, as it is made from silk proteins, and should not accept Seri Scaffold implants. The scaffold should also not be used in pregnant women, as the scaffold can obstruct tissue expansion and therefore be dangerous for an expanding uterus and growing baby. Also, the manufacturer notes the scaffold may be harmful to patients if placed directly on the bowel or viscera because the material may cause adhesions.
Seri Scaffold Marketing and the FDA
In addition to the ripped packaging recall on Seri Scaffold, the FDA also issued a warning to Allergan over its production of Seri Scaffolding related to its marketing of the product. The warning letter from May 2015 states that while the scaffold was approved for use as a “transitory scaffold for soft tissue support and repair” in plastic and reconstructive surgery, it was not approved to be marketed as primarily a breast surgery product. A second letter from the FDA to Allergen in March 2016 shows the manufacturer made acceptable changes to address the violations in the warning letter.