1. Field of the Invention
The present disclosure generally concerns devices and methods for the treatment of infections arising from breast implants.
2. Description of the Related Art
Approximately one in nine women in the United States are diagnosed with breast cancer each year, and approximately 90,000 women per year choose to undergo breast reconstruction utilizing tissue expansion followed by insertion of a permanent breast implant. Unfortunately, approximately 20-24% of these reconstructions will be complicated by development of a periprosthetic implant infection. In addition, in the year 2010 approximately 270,000 women underwent cosmetic breast augmentation, and approximately 2.0-2.5% are expected to develop a periprosthetic implant infection. Periprosthetic infection of an expander-implant breast reconstruction or augmented breast is considered a devastating complication.
A number of recent protocols have been described to attempt to prevent infection in conjunction with the initial breast implant procedure. Such protocols include extensive irrigation of the implant location with antibiotics during the implant procedure (United States Patent Application Publication No. US 2011/0137412 A1), coating the implant with antibiotics (United States Patent Application Publication No. US 2010/0198350 A1; United States Patent Application Publication No. US 2011/0106248 A1; United States Patent Application Publication No. US 2011/0262511 A1), and using implants that are surrounded by an antibiotic-eluting pocket (United States Patent Application Publication No. US 2011/0160854 A1) or biodegradable mesh (United States Patent Application Publication No. US 2010/0168808 A1; United States Patent Application Publication No. US 2011/0082545 A1). Additionally, in cases of reconstructive breast implantation, treatment with antibiotics during tissue expansion (United States Patent Application Publication No. US 2011/0137244 A1). However, even though such protocols can reduce the incidence of periprosthetic breast implant infections, they are not 100% effective.
Initial attempts to treat periprosthetic breast implant infections using antibiotics alone were somewhat effective, but was associated with development of a hard, painful reconstructed breast (symptomatic capsular contracture) in up to 68% of cases (Courtiss, et al., Plast. Reconstr. Surg. 63:812-816, 2003).
Current treatment protocols for periprosthetic breast implant infections employ the use of oral and intravenous antibiotic therapy often followed by surgical debridement and implant exchange, also known as implant salvage (Yii and Khoo, Plast. Reconstr. Surg. 111:1087-1092, 2003; Spear, et al., Plast. Reconstr. Surg. 113:1634-1644, 2004; Spear and Seruya, Plast. Reconstr. Surg. 125:1074-1084, 2010; Bennett, et al., J. Plast. Reconstr. Aesthet. Surg. 64:1270-1277, 2011). This treatment regimen can prove successful for managing mild infections; however, it has a success rate of approximately 25-30% when it is utilized to treat more severe infections.
A recent report details the addition of lyophilized collagen matrix impregnated with gentamicin upon implant salvage (Lapid, J. Plast. Reconstr. Aesthet. Surg. 64:e313-316, 2011), with subsequent absorption of the collagen carrier. However, collagen is a major component of scar tissue, and the collagen matrix could act as a scaffold for dense scar formation, which would lead to the development of a hard, painful reconstructed breast. Furthermore, once the antibiotic has been offloaded the matrix could act as a potential media for bacterial growth.
Failure of the antibiotic therapy-implant exchange protocol requires removal of the implant for 6-12 months. This often produces contraction (loss of domain) of the reconstructed breast requiring that the rather lengthy and painful tissue expansion process be repeated before a new permanent implant is inserted. Removal of the implant from the augmented breast can produce contracture and soft tissue distortion, impairing the ability to achieve a cosmetically acceptable re-augmentation after completion of the waiting period.
Therefore improved devices and methods to treat periprosthetic breast implant infection would represent a significant advance in the art.
USPTO Backgrounds
USPTO Backgrounds