Seri Surgical Scaffold
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.
What Is Seri Surgical Scaffold and How Is It Used?
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.
Seri Surgical Scaffold vs. Other Surgical Scaffolds
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.
Contraindications of Seri Surgical Scaffold
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.
- Abdominal pain
- Difficulty breathing or wheezing
- Difficulty swallowing
- Dizziness or lightheadedness
- Flushing or face redness
- Nausea or vomiting
- Chest discomfort or tightness
- Heart palpitations
- Swelling of the face, eyes, tongue or other affected parts of the body
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.
Seri Surgical Scaffold Marketing and the FDA
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.
- Breast revision surgery
- Mastopexy with or without augmentation
- Breast reductions
- Muscle flap reinforcements
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.
- Medical negligence
- Breach of fiduciary duty (the highest standard of care)
- Lack of informed consent
- Failure to warn
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.
Please seek the advice of a medical professional before making health care decisions.