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Currently, it is unknown to what extent the device may have caused or contributed to the reported event.
To date no medical records have been provided.
Without a lot number a review of the manufacturing records could not be conducted.
It is alleged the patient experienced extrusion of mesh as well as adhesions and hernia recurrence.
Recurrence, adhesions and extrusion are all listed as known possible adverse reaction in the instructions-for-use.
With the currently available information, no definitive conclusion can be drawn.
If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.
This file represents the left perfix plug mesh implanted in (b)(6) 2012.
Additional files have been created to address the right sided perfix plug and the 3dmax mesh implanted on (b)(6) 2016.
The information provided by bard represents all of the known information at this time.
Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Not returned to manufacturer.
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The following was reported to davol by the patient's attorney: on (b)(6) 2012 - the patient underwent emergency surgery to repair bilateral incarcerated inguinal hernias.
The patient was implanted with two perfix plugs-one on the left and one on the right.
A few weeks after his surgery, it is alleged the patient began to experience significant pain in his groin, abdomen and testicles, which the patient described as "burning", "ripping", and "pulling" sensations.
Additionally, he experienced abdominal bloating, bowel issues and frequent vomiting.
On (b)(6) 2012-(b)(6) 2016 - the patient's pain and discomfort increased in severity and the patient sought medical attention and underwent various medical imaging tests to assess his condition.
He was advised by his doctor that the imaging tests demonstrated scarring and inflammation, which imposed difficulties visualizing the mesh.
On (b)(6) 2016 - the patient returned to see the doctor to assess his chronic pain.
Patient was advised that on physical assessment there was a bulge on the left side because his hernia had recurred.
He was referred to a specialist for a second opinion.
On (b)(6) 2016 - the patient was assessed by a second doctor who advised him that he was experiencing pain as a result of the scarring and inflammation around his nerves and spermatic cord.
Patient was also advised that his left side had re-herniated, and that he required surgery to repair the recurrent hernia.
On (b)(6) 2016 - the patient underwent a laparoscopic repair of his left recurrent inguinal hernia using a 3d max mesh.
His operative report indicates that significant adhesions were noted from his first hernia surgery.
Post procedure the patient continued to experience severe groin pain and frequent vomiting.
In weeks following surgery, the patient described feeling a "ripping" sensation from his left groin to the center of his abdomen.
Concerned that his hernia had recurred, patient sought medical attention.
Medical imaging revealed his left hernia had recurred.
On (b)(6) 2017 - the patient underwent a third surgery to repair his recurrent left inguinal hernia.
His operative report indicates that his surgeon "noted the old hernia plug had extruded to be firmly adherent to the spermatic cord.
" the perfix plug was explanted , while attempting to preserve the left testicle.
The attorney alleges the patient continues to suffer from chronic nerve pain, pelvic pain, nausea and vomiting.
It is further alleged that the patient's symptoms interfere with his employment abilities; patient has been unable to work since (b)(6) 2013.
The patient is unable to assist with many of his day to day tasks.
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