Seri Surgical Scaffold has gained popularity in the medical world as an innovative silk netting used to stimulate tissue regrowth with few adverse effects. The product has run into some relatively minor problems, as the U.S. Food and Drug Administration (FDA) has sanctioned the maker for improper marketing and contaminated packaging that puts users at risk of complications.
Seri Surgical Scaffold, a silk netting often used in plastic surgery, serves as a base for the body to regenerate tissue after medical procedures. Both patients and surgeons conveyed high levels of satisfaction and minimal complications with use of the medical implant in clinical trials. It was reported in November 2016, that the Seri Surgical Scaffold had been successfully used in over 10,000 surgical procedures requiring surgical mesh since its inception onto the market, following FDA approval, in early 2009.
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 in an acquisition said to “strategically [align] with Sofregen’s vision of advancing a variety of silk-based solutions to treat patients with soft-tissue defects.”
Chairman of Sofregen Medical Howard Weisman, referred to the Seri Surgical Scaffold as “pioneering technology,” and remarked on the global market’s expectation for products addressing soft-tissue aesthetics to reach $5 billion in 2017.
While the first-of-its-kind product showed a lot of promise, packaging defects led to contaminated scaffolding and serious complications, necessitating a recall at the start of 2013. Additionally, unintended and unapproved uses of Seri Surgical Scaffold have resulted in adverse effects in patients, as evidenced by clinical study data published in 2015.
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 Surgical Scaffold can also be used in laparoscopic surgeries and easily fits into laparoscopic tools.
While silk sutures have been in existence for centuries, the production of other medical devices made from silk didn’t begin until the 2000s, making medical advancements like Seri Surgical Scaffold a relatively new and developing technology.
Silkworms create the silk in a special gland using a combination of protein, salt and water. When preparing for their transformation into moths, silkworms basically vomit the fiber used to craft their cocoons. This substance is processed and used by scientists to manufacture medical technologies such as Seri Surgical Scaffold.
Despite its presumed success thus far, Dr. David Kaplan, a researcher at Tufts University’s Tissue Engineering Resource Center, cautioned, “It takes a good 10 to 20 years before you start to see the real inroads into medical devices.”
Notwithstanding Kaplan’s warning, the human body has almost no immune response to silk, making medical devices made from the substance a well-tolerated and seemingly safe and effective choice for most patients.
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.
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. Furthermore, the purpose for which the Seri Surgical Scaffold was used on the patients involved in the study (two-stage, implant-based breast reconstruction) is determined by the FDA to be a non-approved use of the medical device implant.
|Complication||Percent of Patients Affected|
|Complication Percent of Patients Affected Tissue death (necrosis) or gangrene||6.7%|
|Seroma (buildup of body fluids)||5.7%|
|Hematoma (accumulation of blood outside of the blood vessels)||4.8%|
|Implant loss (extrusion)||3.8%|
|Capsular contracture (scar tissue that causes tightening and hardening of the breast implant)||1.9%|
The official Seri Surgical Scaffold paperwork lists five adverse reactions a patient may experience. All of the complications are consistent with most surgical procedures involving implantable materials.
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 Surgical Scaffold.
In January 2013, the manufacturer, in consultation with the FDA, issued a recall on all Seri Surgical Scaffolds 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 is more likely a patient will experience side effects if the scaffold is not properly sterilized implantation.
Information about the Seri Surgical Scaffold from Allergan in 2014 states that Seri Surgical Scaffold is supplied sterile for single patient use only, and advises physicians to not re-sterilize the product. Furthermore, the information warns that the device should not be used if the sealed pouch is punctured, torn or otherwise compromised.
In addition to the possible complications patients may experience because of Seri Surgical 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 or another reason is the cause of the complication or not and devise a treatment plan.
Treatment of Seri Surgical Scaffold complications varies based on the complication, and is therefore up to the doctor’s discretion. Treatments might include administering antibiotics if a patient experiences infection. On the other hand, if a patient has a silk allergy, additional surgery will need to be performed to remove the scaffold.
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 Surgical 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 Surgical 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, resulting in the death of four patients between 2008 and 2010.
There are three situations in which Seri Surgical Scaffold is not recommended for use. People with silk allergies can experience allergic reactions to the implant, as it is made from silk proteins. Allergic reactions can range from a mild to severe, or even life-threatening. Mild allergic reactions might result in itching, rashes or hives. Moderate to severe allergic reactions can result in potentially serious, sometimes fatal, symptoms.
The scaffold should also not be used in pregnant women, as it is possible for the implant to 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 (internal organs in the main cavities of the body) because the material may cause adhesions.
In addition to the ripped-packaging recall on Seri Surgical Scaffold, the FDA also issued a warning to Allergan over its marketing of the product. The warning letter dated May 29, 2015, states that while the scaffold was approved for use as a “transitory scaffold for soft tissue support and repair,” and that this includes reinforcement of soft tissue in plastic and reconstructive surgery, it the device was not approved for use in breast reconstruction surgeries using a tissue expander or implant.
The federal agency pointed out that the manufacturer’s promotion of the Seri Surgical Scaffold provided evidence “that the device is intended for breast surgery applications, which would constitute a major change or modification to its intended use,” for which Allergan lacked the proper clearance or approval.
Allergan was asked to “immediately cease activities” resulting in “the misbranding or adulteration of the Seri Surgical Scaffold.” A second letter from the FDA to Allergen in March 2016, showed that the manufacturer made changes necessary to address the violations in the 2015 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 (a breast tissue expander) in an off-label experimental manner without telling her.
Wendy Knecht and her attorney filed the lawsuit in Los Angeles Superior Court, alleging that the Seri Surgical Scaffold and breast-tissue expander failed, resulting in her injuries and disfigurement. Knecht claimed the surgeon’s and manufacturer’s negligence and fraud led to an additional surgery to remove the device and repair the damage.
Knecht initially underwent reconstructive surgery after having a double mastectomy due to her high genetic risk for breast cancer. The patient claims she had no knowledge of Lehfeldt’s financial, as well as research-related, relationship with Allergan.
Knecht is seeking punitive damages, or damages intended to deter the defendant from engaging in similar future conduct, as a part of her lawsuit. The case is currently pending.
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