A California surgeon has said the morcellation device violates the standard of care. V.G. Hufnagel, MD, said that she warned Johnson & Johnson back in 1993 that the morcellator would spread disease. The doctor said she told J&J and German morcellator maker Karl Stortz that morcellation would trigger infection, endometriosis, adonomyosis, and fibroids. The doctor also says she told J&J and Karl Stortz that their morcellation devices would kill women with sarcoma.
Morcellator Design Flawed
Dr. Hufnagel, who said she was the first California surgeon to remove a fibroid with a laparascope, has also reported that she told J&J the morcellator was not properly designed. She says she told J&J that tissue cannot be chopped up and then spread all throughout the pelvic cavity.
The “Unexpected Cancer” Lie: How Morcellator violates Standard of Care
Dr. Hufnagel, a self-described whistleblower, said that the morcellator device violates the standard of care. She said the standard of care is simple: “All tissues need to be evaluated for cancer and other conditions before operating on any woman.”
The problem is that no reliable test can now evaluate whether or not a woman’s uterine fibroids are cancerous. Consequently, any surgeon morcellating a woman’s fibroids is taking a chance that they are not cancerous. One wrong guess can kill the patient.
Surgical Oncology – Unambiguous Rules
Dr. Hufnagel says that surgeons and morcellator makers try to explain the unfortunate results as “unexpected cancer.” Dr. H. Cries foul on that explanation. She says that surgeons and device makers have “fabricated the concept of ‘unexpected tumor’ and ‘unexpected cancer’. She says they use those marketing and false medical finding/diagnostic terms to “take away [or cover up] the full knowledge that all have had.”
The surgeon says that during any operation, “all tissues must be treated as if they are cancer.” The doctor wrote: “In the morcellaton process all of the science used to develop oncological protocol to give the best outcome for the patient was and is totally ignored. It is truly madness. A chopper is racing about chopping up tissue emulsifying it into small particles and with it speeds spreading tissue about the body.”
Morcellator Device Violates Standard of Care
Dr. Hufnagel also explains that without full knowledge of the dangers of morcellation, women cannot give their informed consent to a procedure that involves the use of a morcellator.
Surgeon Files Formal Legal Complaint
Dr. Hufnagel filed a formal legal complaint against morcellator makers on Dec. 31, 2015. Her petition includes the claim that she redesigned the device in 1995, which she says she showed and explained to the medical device committee of the FDA.
Dr. Hufnagel’s petition also includes the claims that she wears several hats. She is:
• a gynecological surgical ethics specialist
• creator of a new surgical branch of gynecology called Female Reconstructive Surgery before 1985
• a student of Kurt Semm ( Germany) and Viktor Bonney (UK)
• the first physician to write law to protect patients in the USA, Calif., Texas, New York with informed consent for hysterectomy
• an internationally known women’s health care expert and whistle-blower on abuses.
Dr. Hufnagel, however, is not the first physician to announce that morcellation violates the standard of care. Dr. Amy Reid and her husband, Dr. Hoonan Noorchashm, have also spoken out about the problems of morcellating cancer tissue. Dr. Reid, a mother of five, died of cancer this past Spring after a morcellator was used on her.