Seri Surgical Scaffold, a silk netting often used in plastic surgery, serves as a base for the body to regenerate tissue after medical procedures.
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. And then in November 2016, Sofregen Medical purchased the product line.
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, 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.
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 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
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 manufacturer, in consultation with 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.
If complications develop following surgery, it’s best to consult the surgeon as soon as possible.
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.
Pregnant women and people with silk allergies should not accept Seri Scaffold implants.
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.
In November 2016, a Los Angeles woman sued her surgeon and Allergan alleging they conspired to promote and use the scaffold and another device in an off-label experimental manner without telling her. That case is pending.