The medical device injury attorneys at the Drug Law Center are now accepting cases involving defective innovative tissue regrowth stimulant silk netting products that cause injury.
What is Seri Surgical Scaffold Mesh?
In recent years, Seri Surgical Scaffold Mesh devices have become highly popular among surgeons performing breast reconstruction and contouring plastic surgery procedures. The innovative silk netting material is designed to stimulate the regenerating growth of missing tissue. Doctors implant the surgical scaffold mesh device as a base for the regenerating tissue to provide strength to skin that has weakened and stretched.
The device is formulated with bioengineered silk that can dissolve through biological reabsorption as tissue regenerates in the desired area. Eventually, all the material will dissolve completely and leave only newly formed regenerated tissue behind.
How Is Surgical Mesh Made?
The netting material is fabricated from natural, purified silk protein fibers. The scaffold is constructed into shape through a lattice knitting process to produce a sterile product that can be trimmed into different sizes and shapes without the worry of fraying or tearing. The product is extremely flexible and is used by surgeons in laparoscopic procedures.
Implanting A Seri Surgical Scaffold
During the surgical procedure, the surgeon will place the surgical scaffold mesh over the body part that requires support. During breast reconstruction surgery, this location might be the side or the bottom of the breast for the devices stitched into place as a way to support (scaffold), strengthen and reinforce softer breast tissue. During recovery, missing tissue will regenerate and soft tissue will be repaired until the regrowth of soft-tissue completely replaces the disintegrating scaffold.
The History of Seri Surgical Scaffold Mesh
Approximately a decade ago, Serica Technologies created their Seri surgical scaffold mesh material. However, it was in 2010 when Serica and it surgical mesh product were acquired by Allergan, Inc. Clinical trials at the time indicated the product produced minimal complications and high levels of satisfaction in both surgeons and patients. However, since then, there have been serious complications reported to the Food and Drug Administration and the device manufacturer over contaminated scaffold mesh products in defective packaging.
In November 2016, Allergan, Inc. sold the Seri surgical scaffold product line to Sofregen Medical, Inc. who “remains committed to advancing silk-based medical technologies to address soft-tissue defects.” During the acquisition, the new company’s chairman Howard Weisman stated that “Silk has proven to promote regeneration of the body’s own tissue, allowing for the tremendous potential to effectively repair both disfiguring injuries and delicate defects.” The chairman also stated that “The global market for products to address soft-tissue aesthetics is estimated to reach $5 billion next year. We are excited to be adding the Seri product line to our platform, and look forward to continuing to help surgeons who are eager to restore confidence and improve the quality of life for patients around the world.”
The future of using silk as a healing fiber during medical procedures might be best left to Sofregen Medical, Inc. because they are the pioneer of using this technology “to help physicians address soft-tissue defects, giving patients a fresh start, restoring confidence, and improving the quality of life.”
Side Effects and Complications
The company performed a variety of clinical trials that revealed that complications and side effects associated with Seri surgical scaffold mesh device were rare. Between 2013 and 2015, 139 patients participated in a surgical mesh trial. Of those, six varying complications were recorded. The results were inconclusive and the complications were not attributed to the device. The complications that were reported during the clinical trial included:
- Loss of the Implant (<4.0 percent)
- Tissue Death (<7.0 percent)
- Hematoma (<5.0 percent)
- Infection in the Breasts (1.0 percent)
- Seroma, a Clear Serous Fluid Buildup (<6.0 percent)
In addition, patients involved in the clinical trial experienced at least one of five adverse reactions that were reported including infections, extrusions, adhesion formation, inflammation and fistula formation.
Like every product and device in the medical marketplace, the Seri surgical scaffold mesh device has contraindications where doctors will not recommend that some patients use the product due to their existing condition, allergic reaction or other associated problem. The known contraindications to the surgical scaffold mesh device manufactured by Allergan involve:
- Silk Allergies – Individuals known to have silk allergies will typically have an allergic reaction once the device has been implanted. This is because the product is constructed with silk proteins.
- Pregnancy – Pregnant women, or women hoping to become pregnant in the near future, should avoid using the scaffold during reconstructive or regenerative procedures. This is because the surgical mesh device can obstruct tissue expansion which might be dangerous for a growing baby that is expanding in the uterus.
- Viscera or Bowel Use – The device manufacturer has warned doctors that using the Seri surgical scaffold mesh device directly over the viscera (the abdominal/intestinal internal organ cavity) or the bowel area might be problematic because the silk scaffold material could cause adhesions.
Seri Scaffold Mesh in the FDA
- Allergan Inc. Warned against Using Their Surgical Mesh in off-Label Procedures
May 2015 – The Food and Drug Administration issued a warning to Allergan Inc., the manufacturer of the Seri Surgical Scaffold Device, that marketing their products for breast surgery indications had not yet received approval or clearance by the federal agency. This came after the agency reviewed the company’s website and found the scaffold was being marketed for off-label breast surgery applications. The Food and Drug Asminstaration concluded that the issues “would constitute a major change in its modification to its intended use, for which your firm lacks clearance or approval.”The federal agency reminded the manufacturer that breast surgery indication was not be approved the intended use of the surgical mesh device because the product “has not been cleared or approved for use in breast reconstruction using tissue expander or implant.” Instead, clearance for the product was approved because it could be used “as a transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome.”The FDA in their letter was referring to indications as soft-tissue reinforcement and general soft-tissue reconstruction that is often necessary for reconstructive or plastic surgeries.
- Compromised Seri Surgical Scaffold Mesh Packaging May Have Contaminated ProductJuly 2013 – The Food and Drug Administration sent a product packaging process control warning letter to the Seri Surgical Scaffold Mesh manufacturer, Allergan Inc., stating that “the product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured.”The federal agency mandated that the company take immediate action and on January 8, 2013, “sent an ‘URGENT MEDICAL DEVICE RECALL’ to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers are requested to quarantine and return any unused devices in inventory. In addition, customers are asked to complete and return the acknowledgment form.”The federal agency stated that the patient was more likely to experience some serious side effects that the medical product had not been properly sterilized before its implementation if it had been in a contaminated package.
Surgical Scaffold Mesh Lawsuits
Because surgical scaffold mesh is a relatively new medical device product available to patients and plastic surgeons, it is only now that many women are finding that they have suffered some type of injury following the procedure. One lawsuit involves:
- Breast Reconstruction Device Maker Facing Surgical Scaffold Mesh Injury Lawsuit Filed by California Woman
San Diego (November 2016) – A Los Angeles woman files a surgical scaffold mesh injury lawsuit in Los Angeles Superior Court. The plaintiff is alleging that, without her knowledge, Allergan Inc., the manufacturer of her breast reconstruction surgical mesh device and her plastic surgeon conspired to promote and recommend she use the device in an off-label experimental procedure. The doctor is being sued for medical negligence, lack of informed consent, breach of fiduciary duty, and fraud. Attorneys working on behalf of the plaintiff are suing the device manufacturer for compensatory damages involving fraud, negligence, failure to warn, and punitive damages.Lawsuit documents reveal that Allergan never received FDA clearance to use their breast reconstruction surgical scaffold mesh device together with breast expanders. The complaint also alleges that the device manufacturer and the reconstruction surgeon had an extensive relationship both financially and in providing research information when using both products together.
The plaintiff’s attorney said that “when the surgeon has extensive financial ties to the device manufacturer and is involved in an ongoing clinical trial, he has a duty to divulge that information to his patient.” The attorney also said that his client “did not have any of the protection she would have had as a knowing participant in a clinical trial. There is just no scientific proof or clinical evidence that this Seri Surgical Scaffold, which is derived from so, is safe to use in breast reconstruction surgeries.”
Hiring an Attorney
The medical device injury attorneys at the Drug Law Center have decades of success in resolving personal injury claims and lawsuits involving faulty medical devices and defective medications. We fight aggressively against medical product manufacturers to ensure that our clients receive the highest level of financial compensation they deserve for their injuries.
If you have suffered an injury or lost a loved one due to a defective medical device including the Seri surgical scaffold mesh, we urge you to contact us today to schedule a no-obligation, comprehensive case evaluation at no charge to you. Let us discuss the merits of your case and provide you numerous options on how to legally proceed forward. We can handle every aspect of your case including filing your claim for compensation, providing evidence at trial and/or negotiating an exceptional out-of-court settlement on your behalf.
We are currently accepting all product liability cases, wrongful death lawsuits, and medical malpractice compensation claims through contingency fee agreements. This means you receive immediate legal services and your case is successfully resolved before we receive any payment for our legal services. We offer all of our clients a “no-win/no pay” guarantee. All information you share with our law offices remains confidential.