No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including permanent injury, fistula, infection and subsequent surgical intervention for mesh removal.The instructions-for-use supplied with the device lists fistula as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.In regards to the infection, the warnings section of the ifu states "if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed.An unresolved infection, however, may require removal of the prosthesis." should additional information be provided, a supplemental emdr will be submitted.Not returned.
|
Attorney alleges that on (b)(6) 2009, the patient was implanted with a bard/davol composix mesh in the course of a hernia repair surgery.It is alleged that further to implantation of the product, the patient suffered the development of chronic, pain, scarring, fistula, and infection necessitating removal surgery.It is alleged that the patient has suffered injuries, losses and damages resulting from numerous defects in the product that create an unreasonably high risk of injury with severe permanent adverse health consequences.Attorney alleges that the patient experienced severe pain and suffering, including chronic pain.It is also alleged the patient was treated with a course of hospitalization, diagnostic imaging, revision surgery, serum testing, antibiotics, analgesics and rest.Attorney alleges that the patient will require further invasive repair surgery, physiotherapy, rehabilitation and will continue to require other forms of medical care.It is also alleged that the device was defective.
|