I am not saying the allegations leveled at this birth center are true. I received the press release, and IF the things stated are true, then it is a very grievous situation and breach of trust. I will continue to post updates to this situation as news comes in.
On Christmas Eve, 12 FDA Agents accompanied by detectives and other authorities, raided the Miami Maternity Center in Miami Florida.
Allegedly, the staff was dehydrating placentas on a large scale. According to the press release, they were combining the placentas and subjecting the mothers to cross-contamination without their knowledge or consent.
I am (obviously) a huge proponent of placenta encapsulation. However, I can not in any way condone this type of activity. I created the Training & Certification program specifically to avoid these types of situations.
As an advocate for the movement toward legitimizing the use of placenta for its natural purpose, this story is absolutely outrageous. People who operate with such a total lack of regard for the gravity of the process and who apparently do not realize that the FDA is not on our side, set the movement back and make it harder for the rest of us who are being safe and working toward legitimacy.
Please, people – don’t think that you can find free instructions for drying placentas on the internet and just set up shop. This is serious. You need to comply with government standards and regulations. Get some training. Work with us. Together we can do it. But not when people like this are operating out there.
And to mothers who want help with the encapsulation process – please make sure your provider has been trained. The Placenta Encapsulation Specialist®s listed on the PBi website have excellent training, and operate under OSHA and FDA guidelines. Not everyone who says they can prepare a placenta knows what they are doing, as this story so blatantly demonstrates.
TALLAHASSEE— The Florida Department of Health’s (DOH) South Florida Unlicensed Activity (ULA) Unit announced today that their joint investigation with the United States Food and Drug Administration (FDA) and the Miami Dade Police Department’s Medical Crimes Unit (MDPDMCU) has led to the execution of a federal search warrant at a Miami birthing facility.
The target of the search warrant, the Miami Maternity Center (MMC) located at 140 N.E. 119th Street in Miami, had been suspected of providing unregulated non FDA approved capsules to clients of the facility. During a 10 month investigation by the Unlicensed Activities Unit it was learned that women who had given birth at the center were being provided placenta pills as a prophylactic measure in order to mitigate or prevent post partum depression. This is a practice that has some limited popularity among believers in traditional / ancient medicine, but has not gained acceptance in the modern medical community or FDA approval. When done, the usual procedure provides the birth mother with her own placenta that has been dehydrated and encapsulated for her use. The ULA investigation disclosed that the pills being manufactured at MMC were from the dehydrated, placentas of various birth mothers. The organs would be ground up all together inside of a coffee grinder and placed into gelatin capsules by MMC staff members. The ULA investigation also disclosed that as many as 10 to 15 placentas at a time were being placed in layers inside of the MMC dehydration machine creating a cross contamination hazard. The placenta capsules were then placed into a baggie and stapled to the patient chart. The patients were not informed that the placenta pills they were being provided were placentas from other women that were mixed together with their own placenta for processing.
On Wednesday, December 24, 2008, a team consisting of 12 FDA Special Agents, 6 Miami Dade Police Department Detectives, 2 DOH Investigators and 2 Medicaid Fraud Control Unit Investigators entered the Miami Maternity Center to facilitate the execution of the search warrant. Among the items that were seized were: all patient records from 2006 to the present (approximately 500 patient records), computers, frozen placentas, dehydrated placentas, dehydrator machine, grinding device, prescription pads, billing records and all potential biohazard items. All of the items seized were transported to an FDA facility for further analysis. Federal and State criminal charges against the owner/operator of MMC are pending. This investigation has already resulted in the September arrest of an unlicensed midwife who was working at the facility.