Not Accepting Cases

Seri Scaffold – Side Effects and Complications

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.

Fact-Checked

Editors carefully fact-check all Drugwatch content for accuracy and quality.

Drugwatch has a stringent fact-checking process. It starts with our strict sourcing guidelines.

We only gather information from credible sources. This includes peer-reviewed medical journals, reputable media outlets, government reports, court records and interviews with qualified experts.

Related Pages

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.

These complications include:
  • Tissue death (necrosis)
  • Seromas (pocket of fluid)
  • Hematomas (collection of blood outside the blood vessels)
  • Implant loss (extrusion)
  • Capsular contracture (a response of the immune system to foreign materials in the human body, mostly relating to complications from breast implants)
  • Breast infection
Other serious complications associated with the use of a Seri Surgical Scaffold are those generally seen with surgically implantable materials, including:
  • Infection
  • Inflammation (swelling, redness)
  • Adhesion formation – when two injured surfaces are close to one another and the scar extends from within one tissue to another, usually across a space or void
  • Fistula formation – an abnormal connection between two hollow spaces, usually caused by injury or surgery, but also resulting from infection or inflammation
  • Extrusion (loss of implant)

Tissue Death (Necrosis)

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.

Other risk factors include:
  • Serious injury
  • Blood vessel disease (such as hardening of the arteries in the arms or legs)
  • Diabetes
  • Suppressed immune system (such as in patients with HIV or undergoing chemotherapy)
  • Infection

Symptoms of Tissue Death

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.

The wound might also:
  • Ooze a brownish-red or bloody discharge
  • Become swollen
  • Blister
  • Become painful (this pain is often severe and/or persistent)
  • Make a crackling sensation when pressed

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.

Treatment of Tissue Death

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.

Various treatments for tissue death, or gangrene, include:
  • Amputating the body part with gangrene
  • Emergency surgery to find and remove dead tissue
  • Surgery to improve blood flow, or blood supply to the affected area
  • Antibiotics to get rid of infection and prevent further infection
  • Repeated operations to remove dead tissue (called debridement)
  • Treatment in the intensive care unit (ICU) for severely ill patients

Seromas and Hematomas

Image of a hematoma on a leg
Hematomas and seromas usually resolve on their own

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.

Significant Bleeding and Shock

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.

Symptoms of shock include:
  • Anxiety or agitation/restlessness
  • Bluish lips and fingernails
  • Chest pain
  • Confusion
  • Dizziness, lightheadedness or faintness
  • Pale, cool, clammy skin
  • Low or no urine output
  • Profuse sweating or moist skin
  • Rapid but weak pulse
  • Shallow breathing
  • Unconsciousness

Other Symptoms and Treatment of Hematomas

Did You Know
Hematomas can affect surrounding nerves, blood vessels and organs.

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.

Implant Loss or Extrusion

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.

There can be several reasons for an extrusion, including:
  • Improper wound healing, due to infection or injury
  • Too little tissue coverage
  • Lack of blood supply

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.

Fact
Implant loss results in the need for additional surgical procedures.

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

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.

Treatment of Capsular Contracture

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.

Breast Infection

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.

Did You Know
Infections resulting from surgery associated with medical device implants can be immediate or occur long after surgery.

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.

Symptoms and Treatment of Breast Infections

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.

Pertaining to breast infections specifically, symptoms may include:
  • Breast enlargement on one side only
  • Breast lump or lumps
  • Breast pain (often severe)
  • Fever or flu-like symptoms, including nausea and vomiting
  • Itching
  • Nipple discharge (the discharge may include pus)
  • Swelling, tenderness, redness and warmth of the breast and in the breast tissue
  • Tender or enlarged lymph nodes in the armpit on the same side of the affected breast

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.

Related Pages

Did you find Drugwatch helpful?

14 Cited Research Articles

  1. Allergan Inc. (2014). SERI Surgical Scaffold. Retrieved from https://www.allergan.com/miscellaneous-pages/allergan-pdf-files/ifu_sclfd
  2. ClinicalTrials.gov. NIH. (2017, November 6). The SERI Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery. Retrieved from https://clinicaltrials.gov/ct2/show/results/NCT01256502
  3. Davis, C.P. (2017, November 21). Hematoma. Retrieved from https://www.emedicinehealth.com/hematoma/article_em.htm
  4. FDA.gov. (2015, June 24). Medical Devices: Implants and Prosthetics. Retrieved from https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/
  5. FDA.gov. (2017, April 14). Risks of Breast Implants. Retrieved from: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm064106.htm
  6. Fine, N.A. et al. (2015, February). SERI Surgical Scaffold, Prospective Clinical Trial of a Silk-Derived Biological Scaffold in Two-Stage Breast Reconstruction: 1-Year Data. Retrieved from: http://journals.lww.com/plasreconsurg/Abstract/2015/02000/SERI_Surgical_Scaffold,_Prospective_Clinical_Trial.4.aspx
  7. Greenfield, R.A. & Shaikh, S. (2017, November 21). Gangrene. Retrieved from: https://www.emedicinehealth.com/gangrene/article_em.htm
  8. Jewell, M. et al. (2015, September 16). The development of SERI Surgical Scaffold, an engineered biological scaffold. Retrieved from: http://onlinelibrary.wiley.com/doi/10.1111/nyas.12886/full
  9. justbreastimplants.com. (2016, August). Breast Implant Extrusion. Retrieved from: https://www.justbreastimplants.com/article/risks-of-breast-augmentation/extrusion
  10. MedlinePlus. NIH. (2015, September 10). Gangrene. Retrieved from: https://medlineplus.gov/ency/article/007218.htm
  11. MedlinePlus. NIH. (2015, November 4). Shock. Retrieved from: https://medlineplus.gov/ency/article/000039.htm
  12. MedlinePlus. NIH. (2016, October 4). Breast infection. Retrieved from: https://medlineplus.gov/ency/article/001490.htm
  13. Smith, B. (2007, September 28). What Are Seromas and How Are They Treated? Retrieved from: http://abcnews.go.com/Health/OnCallPlusTreatment/seromas-treated/story?id=3667543
  14. Stephan, P. (2017, July 19). Capsular Contracture and Breast Implants: Causes, Prevention and Treatment. Retrieved from: https://www.verywell.com/capsular-contracture-and-breast-implants-430016
View All Sources
Who Am I Calling?

Calling this number connects you with Wilson and Peterson, LLP or one of its trusted legal partners. A law firm representative will review your case for free.

Wilson and Peterson, LLP funds Drugwatch because it supports the organization’s mission to keep people safe from dangerous drugs and medical devices.

(888) 645-1617

To contact Drugwatch Managing Editor Kevin Connolly, call (855) 839-9780.