To the editor:
My name is Niko Fotopoulos, and I am currently a sophomore studying molecular biology at Princeton University.
I read your article on robotic assisted mastectomy. I also read the follow-up letter by Dr. Chagares and Mr. Goldberg’s response with questions attached. While I may be of some help, I am precluded from many specifics, as I am the clinical researcher on the IRB/Clinical Trial that was submitted and unanimously approved at Monmouth Medical Center. Also, as a student of science, I stand behind my work product.
I met and observed Dr. Toesca when I traveled with Dr. Chagares to Milan, Italy. I assisted Dr. Chagares in New Jersey when we used Dr. Toesca’s clinical trial as the blueprint to create the one submitted to Monmouth Medical Center.
I prepared a multitude of correspondence for the IRB and clinical trial process and extensively prepared for the IRB committee presentation. I took part in the extensive review process as the IRB department had edits, changes, requests and clarifications along the extremely detailed process over the course of multiple months.
Additionally, for the first procedure, I coordinated directly with Dr. Toesca for his proctoring of the surgery and any requests he made to assure the safety of the procedure.
My apologies for not being able to share specifics of the clinical trial. As far as FDA/Regulatory/IDE questions, I would not be able to assist with those answers, as those decisions were made by the hospital IRB office.
The clinical trial was extensively vetted by the IRB committee and received unanimous approval.
Best,
Nicholas Fotopoulos
Princeton Class of 2021
AB Molecular Biology with Certificate in Entrepreneurship
To the editor:
My name is Brian Thomson, and I am a patient of Dr. Chagares’s. I read your article on robotic mastectomy, and I want to clarify that the article is not accurate. On Sept. 28, 2018, Dr. Chagares performed my robotic assisted bilateral mastectomy at Monmouth Medical Center.
Prior to my surgery, I had consultations with Dr. Chagares and a full work up. Dr. Chagares gave me several surgical options to remove the masses in my breasts.
Dr. Chagares clearly explained that the robotic approach was in an IRB/Clinical Trial. He also explained that Dr. Toesca from Milan, Italy, trained him, and confirmed that I would be the first male robotic mastectomy performed worldwide.
We discussed the risks, benefits and complications of the surgery. We discussed the protocol of the clinical trial and what would be required of me after surgery.
Dr. Chagares explained that I would need to continue to see him twice a year for physical examinations and to complete a questionnaire at each visit so he can collect the information for his long-term trial.
Dr. Chagares and his staff spent an unbelievable amount of time answering all of my questions and explaining the surgery to me.
I felt very comfortable making the decision that the robotic assisted mastectomy was the approach for me. I signed the Monmouth Medical Center consent for surgery along with the Monmouth Medical Center documents consenting to participate in an IRB/Clinical Trial.
My experience with Dr. Chagares was absolutely outstanding.
I hope this helps clarify the inaccuracy of your article.
Thank you,
Brian Thomson
The editor responds: The Cancer Letter is grateful to Mr. Fotopoulos and Mr. Thomson for writing to us.
Because of incorrect information provided to us, The Cancer Letter reported erroneously that Dr. Stephen Chagares had performed two robotic mastectomies without a protocol (The Cancer Letter, April 5).
This was a minor part of a story about the controversial procedure that is considered investigational.
While the rest of our reporting stands, we have annotatedthe original story to reflect the error, posed a series of questions to Monmouth Medical Center and Dr. Chagares, and published a correction.
Reporting on this story is ongoing.
