Fascia Blaster massagers and vibrators

The reports, as CPSC published them

1. Seen by a doctor or nurse

   Made Aug 3, 2017 · , sent to the company Aug 11, 2017 · , published by CPSC Sep 1, 2017

   The product, in the report: The FasciaBlaster is a 2-foot plastic massage stick with 4 large claws. The Mini1 has a handle, 1 claw, and a pointed nugget tip. The Mini2 is a smaller version of the FasciaBlaster with two claws and 2 pointed nugget tips. The FaceBlaster is an even smaller version with smaller claws to blast the face and neck. Finally, the nugget is a pocket-sized pressure point tool with two pointy tips used to break up chunky fascia-bound areas. Customers are instructed to rub their bodies vigorously for 5 minutes per area up to a pain level of 7 to eliminate cellulite. There are hundreds of tutorials showing customers how to use this product. Bruising is encouraged. Protocols recently changed due to customer complaints of injury but the company denies that any injuries occurred.

   Although I have experienced adverse side-effects from this tool, I am writing this report on behalf of all customers who’ve been injured, ignored and even harassed by ADB Interests. The information below will give you an idea of all the reasons why we believe this company should be investigated.

   ABOUT THE PRODUCT: 1. [REDACTED] has stated the FasciaBlaster is FDA APPROVED. This is incorrect. The FasciaBlaster is REGISTERED with the FDA as a Class I exempt device. 2. US Patent labels on FasciaBlasters vary. Some read “The FasciaBlaster meets US FDA definition of Class I medical device”. Other labels read “This is not a medical device”. 3. [REDACTED] is a self-proclaimed Guru, innovator, scientist and pioneer in the field of fascia. [REDACTED] has no medical background. It can’t be confirmed that she holds a professional license or has a college degree. She has claimed to be a licensed LMT, which we were unable to find record of. She also claims to be a fitness instructor, who “worked with professional athletes, celebrities, models, billionaires, and royals who came to rely on her to treat their injuries in order to win a playoff season, walk the runway, or film a major production.” This appears to be true, but we suspect she may have worked without a license at that time. [REDACTED] 4. [REDACTED] claims her parner, [REDACTED], is a neuroscientist. We cannot find proof that this is true. She is a specialized Physical Therapist. 5. [REDACTED] and some of her team members have been heavily criticized for providing advice on medically-related issues, including but not limited to, use of the FasciaBlaster before/during pregnancy, post-partum issues such as diastasis recti, sciatica, Fibromyalgia, treatment of varicose veins, Parkinson’s, etc. They dispense advice daily on their Facebook support group, they have numerous videos on YouTube and they request customers send them private messages for treatment protocols for specific problems. Here they discuss the “science” behind the product: [REDACTED] 6. Customers have complained that the labels on the creams and oils do not include ingredients. 7. [REDACTED] claims the FasciaBlaster will lyse fat cells, but many women have complained of weight gain. [REDACTED] has coined the term “Worse Before Better” and often tells women who start gaining weight to blast through it. This has caused many women to gain more and more weight. 8. [REDACTED] states use will not affect hormones and that it will not increase estrogen levels. Then she states it releases Irisin (a hormone naturally found in muscle cells that increases in the body when we exercise, boosting the amount of energy we expend and controlling blood sugar levels). 9. Many women who have used the FasciaBlaster on their stomachs have reported hormonal issues such as extreme cramping, missed periods, unusual bleeding (in some cases, lasting up to 10 days), missed periods, depression, anxiety, etc. [REDACTED] claims these side-effects are not hormonal, but are part of the detox process, which is a good thing. She explained this once as “it is your body getting rid of the gunk.” 10. Excessive bruising is encouraged. She wrote a blog called “The News on the Bruise” where she describes the bruise caused by the FasciaBlaster as healthy. [REDACTED] 11. Women started reporting side effects after use of the FasciaBlaster, such as worse cellulite, spider veins, increase in varicose veins, bruise staining, crepe skin, loose skin, fallen face, claw lines, increased inflammation, crepitus (inflammation of the fascia), weight gain, adrenal fatigue, thyroid issues, hematoma, blood clot, degradation of the body, hormonal changes, mood swings, depression, anxiety and panic attacks, heart palpitations, difficulty breathing, dizzy/lightheaded, vertigo, flu-like symptoms, joint/muscle pain, muscle spasms, nerve pain, headaches, numbness, itching or burning sensations, hives, hair loss, viral outbreak, chest pain, etc. 12. After many women came forward publicly about their injuries [REDACTED] changed the Terms & Conditions of the FasciaBlaster. Those changes were made on 5/22/17, however she still denies that there are any reports of adverse effects or injuries. 13. [REDACTED] changed the protocols without properly notifying her customers. She later denies that the protocols ever changed. 14. [REDACTED] has stated that online instructions and instructional videos have never been deleted, but web archives show this is not true. [REDACTED] 15. [REDACTED] tested the FasciaBlaster in late 2016. She called her trial a “double blind” study, which we believe is not true. Only 33 women completed the study, all were healthy, several participants were personal friends, and 1 is an employee. Many had been blasting for months prior to the study. A casting call was put out to find the participants. [REDACTED] 16. We are not able to find proof that the “trial” was reviewed by the Institutional Review Board (IRB), however [REDACTED]states that it was. Note on IRBs: Each federally supported or conducted clinical study and each study of a drug, biological product, or medical device regulated by FDA must be reviewed, approved, and monitored by an institutional review board (IRB). An IRB is made up of doctors, researchers, and members of the community, Its role is to make sure that the study is ethical and that the rights and welfare of participants are protected. This includes making sure that research risks are minimized and are reasonable in relation to any potential benefits, among other responsibilities. The IRB also reviews the information consent document. In addition to being monitored by an IRB, some clinical studies are also monitored by data monitoring committees (also called data safety and monitoring boards). 17. [REDACTED] said she does not plan to publish the results from her study, or allow the results to be reviewed by the medical community or anyone else.

   ADVERTISING / CUSTOMER SERVICE 1. Many of her before/after photos have been found on various plastic surgery websites as before/after photos for liposuction. When questions, [REDACTED] once accused various plastic surgeons of using her photos. 2. Many of the photos used for advertising purposes appear to be altered. 3. [REDACTED] husband, [REDACTED], claims that one set of photos is actually [REDACTED] (she posted the images twice, once saying the pictures were her, and another time, saying the pictures were someone else). According to [REDACTED], those photos were taken just moments apart and altered to appear as if it was a transformation. 4. Without obtaining consent, [REDACTED] has advertised with before/after images of customers who have posted temporary results on the FasciaBlasters closed group Facebook page. Some of these customers have complained that they have repeatedly asked her to remove their photos from all marketing materials because (1) they did not provide consent, (2) the photos are misleading as they do not show the damage that occurred after the photos were taken, (3) they no longer support this product. 5. We believe she used a photo of a women that was 8 months pregnant as the before and then 4 or 5 months postpartum as the transformational after. She never stated the woman was pregnant in the photo. 6. Many women who have experienced adverse side-effects complained that they were blocked before ever being able to leave a review on the [REDACTED] Facebook page. It is unknown how many have been blocked to date.

   HARASSMENT 1. [REDACTED] created a private Facebook support page for customers called “FasciaBlasters”. This is a forum for [REDACTED] to dispense advice/instructions/tutorials, promote her products, and allow her members to discuss their progress. As customers started to complain of side-effects and injuries, they reached out on the “FasciaBlasters” Facebook group for support. As a rule, negative comments are not allowed and posts regarding potential side-effects are often rejected or deleted by moderators. Lastly, members who have tried to comment on what is deemed negative have been blocked from the group. 2. People who have posted about negative side-effects are often called “haters” and a “trolls” by [REDACTED] in her FasciaBlasters group. 3. Many of the blocked women started forming alternative Facebook groups, such as “[REDACTED]”, “[REDACTED]”, “[REDACTED]”, etc. [REDACTED] found out about the groups and we suspect she and her moderators have created fake profiles to gain information which she uses to intimidate members in these groups. 4. [REDACTED] now asks her customers to email her their medical records as proof of their injuries. To date we are not aware of anyone who has complied, and several customers have verbally refused as she is not a licensed medical professional who is bound to HIPAA laws. 5. [REDACTED] has warned customers who report negative effects that the FBI, Facebook and local law will be involved in stopping the spread of untruths about her product. She has accused many customers of slander and libel. 6. On 5/15/17,[REDACTED] released a public video statement addressing the “hate groups”. Amongst other things, she said there were violent threats made against her which to our knowledge is not true. 7. In response to negative feedback on the FasciaBlasters UK Facebook page, [REDACTED] referred to her ex-husband, [REDACTED], as a person who runs and recruits members to his hate group. She said he has mental issues and a restraining order. She said he is stirring women up and she is personally saddened that anyone would fall prey to this man. 8. [REDACTED] hired a private investigation firm, Aren Investigations, in partnership with Black Ryno Security. Black Ryno invited many members of negative effects Facebook pages to be members of their page. The invitations read “I would like to personally invite you to the Ryno Black Security group. I am here to present information to uncover the truth. You will learn the reality about many people you are interacting with”. 9. Aren / Black Ryno created several Facebook posts directed toward members of negative effects pages. Here they accused members of these groups for posting false medical symptoms, fake medical reports, and giving medical diagnosis and medical opinions without being medical professionals. They also accused members of taking pictures off the internet of various medical injuries and attributing them to themselves to incriminate [REDACTED]. They compared the negative effects Facebook group to a hate-group. In one post, they accused the negative effects page administrator of “committing a felony of the third degree by violating The Legislature of Texas Section 1 Chapter 33: ONLINE HARASSMENT”. They said that these negative effects pages are not displaying “normal” behavior, and that women are putting themselves at risk by participating in these groups. 10. Black Ryno ran background checks on a few customers who complained of adverse effects. One customer had been to jail and Black Ryno posted information about her criminal history as well as her mug shot on their Facebook page. Two other members were discussed on a Facebook post, as they had been arrested for DUIs at some point in their lifetime. 11. On 7/8/17, [REDACTED] of Black Ryno posted a warning message to all business owners, calling out certain individual members of negative effects pages as professional trollers who make false claims with fake profiles. He listed 50 women by name, asking other business owners to block these individuals from their business pages. This post was removed later that day. 12. A few members have complained that their Facebook accounts were recently hacked and their private messages with [REDACTED] were deleted. A couple of these members checked their Facebook security settings to learn that they were logged in to an unknown computer in Texas. There is some speculation that these women may have used their Facebook password when they registered with [REDACTED] to purchase their FasciaBlaster, therefore inadvertently providing [REDACTED] with their Facebook passwords. At this point, there is no substantive evidence that proves that [REDACTED] or anyone on her team actually hacked into their accounts. 13. [REDACTED] sent Cease and Desist Letters to women who gave her negative reviews on her [REDACTED] Facebook page. LAWSUITS 1. [REDACTED] and ADB Interests began filing lawsuits in an apparent attempt to silence anyone who was considering speaking out about injuries they sustained using the FasciaBlaster. [REDACTED] also posted a copy of the lawsuit on her [REDACTED] website for public view. [REDACTED] 2. [REDACTED] threatened customers with lawsuits for making negative comments about her and her product. She also admitted that she had several spies with fake profiles as well as her attorney on the negative Facebook pages as members.

   Bought from

   Online

   Bought

   Aug 9, 2016, about then

   Where

   Laguna Niguel, United States Minor Outlying Islands: Unspecified

   Who was involved

   Female

   The reporter’s relation to them

   Self

   As this report names them

   Brand FasciaBlaster, made or sold by Ashley Diana Black International Holdings, LLC

   How badly, in CPSC’s words

   Injury, Seen by Medical Professional

2. First aid

   Made Aug 3, 2017 · , sent to the company Aug 11, 2017 · , published by CPSC Sep 1, 2017

   The product, in the report: contains dangerous BPA plastic. its basically a plastic stick with knobs and pokey points. its used for pain or for cosmetic purposes like breaking up cellulite. when used this product causes blunt force trauma to the body and severe bruising is a sign of bkunt force trauma. it says class 1 medical device

   i am writing this report about a product called the Fascia Blaster and it is being sold as a FDA class 1 medical device. this product is marketed to women on facebook. this product has caused a wide range of side effects. i was unaware of the potential side effects when i purchased this item. the owner of the company, her name is [REDACTED]. she actively misinforms her customers and misleads them. [REDACTED] uses fake science to prove that her product works. for example, [REDACTED] has always told her customers that bruising is healthy and a sign of healing blood being returned there. there’s ample documented evidence of [REDACTED] advocating her product and bruising. many of her customers believe the fake science that she preaches. another aspect of the fascia blaster is that it causea a “detox”. [REDACTED] says that the detox is normal. i was unaware of the detox side effects before buying the item. i was never informed side effects or detox was possible, i was told to expect bruising because it was healthy. i used the device 3 times. the 3rd time i used the device, i heated myselfin a hot tub/steamy room and then i did a “full body blast” as reccomended by the [REDACTED] guru. i never went above a pain level of 5. the next day i had extreme side effects and extreme detox. i had pain when urinating for 3 days after. i had severe deep bruising. i had a massive influx of spider veins on my legs,arms shoulders,knees and butt. My body was sore. i felt lethargic. in the weeks to follow, i experienced extreme depression and anxiety. my menstration cycle suddenly changed (never happened to me before) it has been 6 weeks since i used the product and i still have bruises that wont fade and spider veins. my legs have dents in them,crepe skin, and loose skin at my knee that i did not have before. my legs are now physically deformed. they are different and damaged now that i have used the fascia blaster. sadly, my daily lain level has increased dramatically, at least 60% more pain than before. in the morning, my joints are stiff and inflammed and i struggle with moving my fingers and it hurts for me to clench my fists. this has impacted my day to day life because i work with my hands. i am scared about long term effects this may have on my hands. if i had been informed of these side effects i never would have used the product. i am a woman who may become pregnant and detox is not safe for women who want to get pregnant/are pregnant/or are nursing. the fascia blaster has no warning about this amd i saw screen ahots of [REDACTED] saying she thinks its safe. i never would have bought this item had i known about detox. lastly, i have been publicly bullied by ashley blacl and her company. i left a review on facebook about my concerns with detox and i was blocked and then publicly bullied and ridiculed for my concerns. i am afraid to reveal my identity to this company because they are bullies. i believe customers are in serious danger when it comes to the fascia blaster. i believe woman may suffer miscarriages or a change in lactation as a result of detox. this product has BPA plastic and [REDACTED] tells you to heat yourself and the tool to get the heat results. turns out heating BPA and rubbing it over your body with oils allows the BPA to seep into the body. when BPA is absorbed in the body it becomes a synthetic estrogen. could this be why my menstration cycles changed after 10 years of being exactly the same? this product is a danger.

   Where

   Unspecified: Unspecified

   Who was involved

   Age 28, Female

   The reporter’s relation to them

   Self

   As this report names them

   Brand fascia blaster, made or sold by Ashley Diana Black International Holdings, LLC

   How badly, in CPSC’s words

   Injury, First Aid Received by Non-Medical Professional

3. Seen by a doctor or nurse

   Made May 27, 2017 · , sent to the company Jun 6, 2017 · , published by CPSC Jun 20, 2017

   The product, in the report: Fascia Blaster Mini2 and the Fascia Blaster, handheld body tool used to smooth out fascia made with BPA plastic, white in color with 2 or 4 claws attached.

   I used a product called the Fascia Blaster as directed by the inventor, [REDACTED], in her various videos, private Facebook Groups and posts on her business Facebook page on or around April 13th, 2017. This is not the first time I had used the product, but it was the first time I used the Fascia Blaster to do a full body treatment, as recommended by [REDACTED]. After this specific date of use which was in a hot bath, recommended to heat up your body, therein heating up your fascia, I experienced nausea and extreme dizziness that did not subside. After two and a half weeks of this dizziness, I went to my doctor for a diagnosis. I was diagnosed with BPPV or Benign Paradoxyl Positional Vertigo. The symptoms to this lasted a total of six weeks before finally subsiding. This was debilitating in that it affected my sleep and every day life, as my balance was off and I fell various times upon standing from a laying or sitting position. I believe, now, that this was caused due to an increase of inflammation in my body. I had previously used this product on various parts of my body about ten times in the previous month and a half and each time I suffered various detox symptoms, including swollen lymph nodes, viral outbreak of HSV after the first use, bloating, numbness in arms and hands. I researched this product for almost 2 months before purchasing and saw absolutely nothing but positive reviews. It has now, recently come to my attention that [REDACTED] and her staff systematically delete negative comments and posts from her consumers stating negative results from her private Facebook groups and Facebook pages in an attempt to hide this information from other consumers. [REDACTED] also delete and block these consumers from contacting or commenting after their honest reviews on her Facebook business page [REDACTED]. Many people have now stated adverse effects related to the Fascia Blaster and [REDACTED] denied any of these claims, although just recently on May 27, 2017, the company has updated it Terms & Conditions to include the various symptoms people have complained about, although they were told their claims were false via private messaging. I find these deceptive business practices to hide possible side effects from your consumer for over two years! Had I known any of these possibilities, I would not have purchased this product or her book off of Amazon. [REDACTED] has absolutely no credentials to be giving the type of advice and suggestions she does to her consumers. She is not licensed in anything. I feel this product needs more testing before it is allowed to be sold to consumers all over the world. I also want to state that I had a yearly wellness checkup about a week before using this product and I was a healthy 46 year old woman with none of the symptoms I suffered after using the Fascia Blaster.

   Model

   Mini2 Batch run 1.0 121716, US Pat D735,818

   UPC

   none

   Serial number

   89-IOD at 21 CFR 890.5350

   Bought from

   www.ashleyblackguru.com

   Bought

   Mar 9, 2017

   Where

   Lynnwood, Washington: Home/Apartment/Condominium

   Who was involved

   Age 46, Female

   The reporter’s relation to them

   Self

   As this report names them

   Brand Fascia Blaster, made or sold by Ashley Diana Black International Holdings, LLC

   How badly, in CPSC’s words

   Injury, Seen by Medical Professional

CPSC’s disclaimer

Sources