The Seri Surgical Scaffold, a mesh made from silk, is used to support and repair weaknesses and damage in soft tissue. A clinical study linked the implant to several serious side effects and complications when used in a certain off-label procedure involving breast reconstruction. These complications include tissue death, implant loss, seroma, hematoma, infection and capsular contracture.
The Seri Surgical Scaffold is a medical device derived from silk and used to support and repair weaknesses and voids in soft tissue in plastic and reconstructive surgery. The material is designed to dissolve or be absorbed by the body. It was studied in the U.S. in 139 patients observed for two years in a clinical trial called SURE-001. Patients underwent two-stage, implant-based breast reconstruction using Seri Surgical Scaffold.
In February 2015, interim data was reported for 71 patients who were tracked for one year. The data revealed that the device may be linked to several serious side effects and complications in patients who used it specifically for breast reconstruction.
Implanted medical devices often come into contact with surrounding tissues, potentially leading to complications. One such complication is the death of body tissue called tissue necrosis. This serious condition occurs when the tissue lacks adequate blood supply due to too little blood flow.
When large areas of tissue die due to the lack of blood flow caused by injury or chemicals, the irreversible condition is referred to as gangrene. Gangrene can involve any part of the body, although it most commonly affects the extremities, such as the toes, fingers, feet and hands. Surgery is one of the factors that puts a patient at a higher risk for gangrene.
Symptoms of tissue death and gangrene depend on the location of the body affected by the condition. When the skin is involved and the dead or dying tissue is located close to the surface, the symptoms can include discoloration (blue or black if the skin is affected, and red or bronze if the area beneath the skin is affected), foul-smelling discharge or loss of feeling in the affected area (this symptom may occur after severe pain in the area).
When the affected area is inside the body, different and sometimes more severe symptoms may occur. Tissue death inside the body may present as gas gangrene, or gas in tissues beneath the skin. Gas gangrene is a type of gangrene caused by the bacteria Clostridia. The infection-causing bacteria can only grow without oxygen. As it grows, it produces a toxic gas, therefore, the name. With gas gangrene, the wound will be infected.
If the toxins spread to the bloodstream, a patient may experience fever, increased heart rate and rapid breathing.
Other symptoms associated with necrosis and gangrene affecting tissues inside the body include confusion, general ill feeling or low blood pressure.
Once tissue death has occurred, it is not able to be reversed. However, the condition requires urgent medical attention and treatment to prevent further injury or, in some cases, death. Primary treatments include surgery and the administration of antibiotics. A hospital stay is required for treatment.
Dead tissue should be removed to allow the surrounding healthy tissue to heal and to prevent the spread of infection. Other treatment options and a person’s overall outlook will depend on the area affected by tissue death or gangrene, the patient’s overall condition and whether they have accompanying diseases or injury, and the cause of tissue death or gangrene.
A seroma is a collection of clear body fluids in an area of the body where tissue has been removed during surgery, while a hematoma is a collection of blood (usually clotted) outside of a blood vessel. Seromas are likely to develop in voids, or open spaces, left during surgery. A hematoma often results due to damage to the wall of the blood vessel allowing the blood to leak into the tissues.
Usually, seromas and hematomas can resolve on their own. Most seromas are reabsorbed back into the body within about a month, but sometimes can take up to an entire year. In some cases, however, complications can occur, such as increasing fluid buildup; pressure on the area that is healing; infection, presenting with symptoms of redness, warmth or tenderness; or increased swelling.
In such instances, the seroma may need to be drained. A surgeon can insert a needle through an incision into the collection of fluid and drain the seroma with a syringe. This drainage will help to relieve pressure and provide faster healing.
The body is also likely to be able to repair the injured blood vessel resulting in a hematoma by clotting the blood. However, if the damage is significant or large, or if the patient has blood clotting problems, continued bleeding can occur leading to further complications. Hematomas can expand causing increased blood loss, which can result in shock, a medical emergency.
Aside from bleeding and shock, hematomas may cause other symptoms. Accompanying symptoms depend on the location and size of the hematoma, as well as any swelling, fluid buildup or pressure on nearby blood vessels, nerves or other structures in the body. Most hematomas result in symptoms of inflammation, including pain, swelling and redness.
Sometimes, hematomas can be treated at home with over-the-counter (OTC) pain medicines and RICE (rest, ice, compression and elevation of the affected area). Depending on the location of the hematoma, what parts of the body are affected by the hematoma and the patient’s symptoms, additional treatment may be needed. A patient’s condition will usually be observed for a period of time. Surgery may be necessary when complications, such as shock, occur.
Over time, medical implants, such as the Seri Surgical Scaffold, can also move. Sometimes this movement can result in loss of the implant, or extrusion. Extrusion means that the implant is literally thrust, forced out or expelled from its position in the soft tissue or the body. The tissues may be unable to hold the implant in place, leading to the breakdown of skin, causing the implant to protrude from the site of the surgical wound.
Contributing factors may also increase a patient’s risk of experiencing an extrusion, such as engaging in strenuous activity too soon after surgery.
When extrusion occurs, additional surgery is needed to remove and replace the medical device implant. This may cause further scarring or loss of tissue in the affected area.
When the device is not removed and replaced, movement of the implant or extrusion can result in other complications, such as capsular contracture.
Capsular contracture is a condition that results when scar tissue forms and tightens (contracts) around an implanted device, such as a Seri Surgical Scaffold. The scar tissue squeezes the implant and leads to firmness or hardening of the affected tissue. Capsular contracture can be painful.
In the specific clinical trial relating to the Seri Surgical Scaffold, capsular contracture occurred in approximately 1.9 percent of patients’ breasts. The condition is considered an immune response to protect the body from the implanted medical device detected as a foreign object, or intruder. The “capsule” of scar tissue thereby isolates the device, preventing it from spreading and affecting other parts of the body.
Capsular contracture may also be preceded or accompanied by infection, hematoma or seroma. However, its exact cause, and why it occurs in some patients and not others, is unknown, according to the FDA.
Treat of capsular contracture depends on the severity of the condition and whether it is accompanied by other complications. As it pertains to the breasts, there are four grades of capsular contracture. These grades are called Baker grades, and are outlined in the following chart.
|Baker Grading Scale|
|Grade I||Breast is usually soft and looks natural|
|Grade II||Breast is slightly firm, but still looks normal|
|Grade III||Breast is firm and starts to look abnormal|
|Grade IV||Breast is hard, painful and does not look natural|
Grades III and IV are considered serious and often require additional surgery. The surgical procedure may involve removing the device with or without its replacement. If the device is replaced, capsular contracture can recur after surgery.
Surgery can also be used to loosen the scar tissue.
Non-surgical treatment options might include a massage, an ultrasound or medications to relax the stiffened capsule.
In an advisory related to medical implants, the FDA acknowledged that infections are the most commonly seen side effect or complication of a surgical procedure to place a medical device, such as the Seri Surgical Scaffold. Most infections come from skin contamination near the surgical site at the time of surgery. Surrounding tissue near the site of the implant will then become infected by microorganisms and symptoms will result.
Infections can be superficial (caused by bacteria near or on the skin) or deep (caused by skin-dwelling or airborne bacteria). Deep infections can also enter the body via the implant itself. Both superficial and deep infections are generally immediate. A third type of infection, called late infection, can occur months or years after the surgical procedure, caused by dormant (temporarily slowed or stopped) blood-borne bacteria present on the medical device implant prior to its insertion.
When infections affect the breasts, they are usually caused by bacteria called staphylococcus aureus, which are naturally found on the skin. The bacteria enter the body during surgery, affecting the fatty tissue of the breast. Swelling can put pressure on the milk ducts, which results in pain and lumps in the infected breast. Breast infections can also be related to a rare form of breast cancer.
Bruising at the surgical site, pain, swelling and redness can occur after a surgical procedure to implant a medical device, such as the Seri Surgical Scaffold. When the surgical site or tissue surrounding the medical implant becomes infected, additional symptoms can occur.
When an infection occurs, it may be necessary to have a drain inserted near the implant. Other treatments include medications, such as antibiotics or pain relievers, or additional surgery to have the implant removed or replaced.
Please seek the advice of a medical professional before making health care decisions.
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