Allergic Reaction to Bio-Oss: Is it Possible?

maybe the gloves.

I would call bio-oss.

What kind of grafting procedure did you perform? What type of sutures did you use? Is the patient on antibiotics, rinse or systemic? Did you sever a small artery? Did you release the periosteum and achieve passive primary closure? What does it look like intraorally? Did the patient try to brush or floss? Were the teeth cleaned prior to grafting?

I agree with V..may be gloves or more likely something else which neither you nor your patient aware of !! Also good suggestion from Sabolch - call Bio-OSS.

Just read Kim. Too many possibility. Impossible to pin down the correct cause. If it has been established the allergic reaction and patient's on recovery path ..I wouldn't worry much until I have similar situation with different patient again. Then may be I try to figure out If something I'm doing wrong or something wrong with Bio-OSS.

The whole grafted stuff should be removed as soon as possible, as the causative agent is unknown.

Maybe the patient has an allergy to collagen.It's rare but still happens. The BioGide is a procine origin collagen membrane and the BiOss although it should be protein free it might have some residuals. I would extract the graft (both membrane and bone) and contact Geischlik (teh manufacturer) to report the incident. They need to track these incidents.

As a general rule of thumb, the larger the particle size and the denser the particle the harder it will be for the body to resorb. This being said this means a greater strain on the reticuloendithelial system. I say use a synthetic like Osteogen when you can and use ICB elsewhere. The ptfe membranes cause a little local irritation but the materials with growth factors, even the patients PRP can cause a localised rxn.

Dr Hughes, Are you an owner of Osteogen? Every post you promote that crap! This patient could care a less about the general rule of thumb. More than likely she is allergic to latex. In 25+ years and millions of cases with Geistlich this has never been a problem. That is why I use it. The most reseached product on the market! I feel, and my patients, very safe with it. Dont let your uneducated jibber jabber taint others.

To blame BioOss and BioGuide for such a reaction in a case like this is simply nonsense. There could be many reasons for an alergic reaction like this. I agree, one of those are the gloves, but usually we prescribe amoxicillin in such augmentations and it is well known allergen. Did you prescibe some antibiotic treatment?

Theoretically, an individual can be allergic to anything because anything can be an allergen i.e. a substance that is considered by the immune system as a foreign body. Once the immune system identifies a foreign body, it responds basically 4 different possible ways.....4 types of hypersensitivity mediated either by B cells of T cells. Your patient's sounds like the 4th type....T cell mediated delayed hypersensitivity......allergic contact dermatitis likely due to your gloves..powder....ointment or something that touched your patient's face. Treatment is usually steroids systemic or topical or both. If things are getting better, that means things are getting better and no drastic treatment like removing the grafts etc. is necessary. Just make a note on your patient's record and avoid the possible causes in the future. Cheers!

BioOss is an excellent product, but bear in mind it is sintered at 300 degrees Centigrade, well below the threshold of 600 to 640 C needed to remove protein and prions. (see JP David Cochran U Texas) who showed the residual protein may be the reason BioOss has a DFDBA-like inductive capacity.

Good point Dr. Thompson ,also the growth factors can kick in the Cox 2's.

Just because someone does not use xenograft materials ,it does not mean they thus must have a financial interest elsewhere.There has been little research into foriegn body response to graft materials which could have been the case here. There have been other cases of a similar reaction here in the UK.Is it serious,no. Xenografts have an enormous amount of research in their usage but there are alternatives which work as well available now with a number of new very interesting papers to be released.

Dr. Chow has it right.

Dr. Hughes, You mentioned that PRP can cause local allergic reaction. Could you explain why?

Gaby Teng, Products of arachidonic acid are mediators of inflammation. COX 2 is a product of the oxidation of arachidonic acid. COX 2 is synthesized as a response to cytokines (eg. interlukin-1B, growth factors (eg. transforming growth factor-B, epidermal growth factor, platelet derived growth factor and figroblast growth factor)and free radicals in inflammed tissue. So, when using PRP, one is kicking in the COX 2 factor. This should be controlled by NSAIDs and steroids. I hope this answered your question.

Thank you Dr. Hughes.

I can't believe you guys. I had bio oss used on me 5 years ago. Never resorbed, still having chunks that have migrated everywhere taken out, gross sinus problems because of migration into the sinus. Dysguesia also. Why would any of you use this product? My dentist has photos of chunks he has been taking out. The company should be sued as well as the people who use this garbage.

Having never used it I cannot comment but one of the benefits of the synthetics is that they are fully resorbed at 6 to 9 months depending on patient physiology. Thus all you have is the patients own bone which can be monitored simply by radiographs.Having used them solely for the last 5 years I have not seen any repneumatisation over this period negating the need for HA.

Dear Paul Carie, It's unfortunate that you had this experience. Grafts fail for many reasons. This sounds as if you did not have an adequate blood supply to the graft material. My rules of thumb is an adequate blood supply, stability of the graft (this one is also a patient compliance issue, the larger and denser the graft material the longer it takes to resorb and form bone, etc. The patient's biology is also a huge factor in this equation ( age, ability to regenerate bone, systemic disease, genetic issues, over all health etc)

BioOss is only a filler. It can't make the body to grow bone. The problem is it is dense HA that does not resorb. Also, the empty sites where the osteocytes were are 20-30 microns in size. Oral pathogens are only .0-1.0 microns in size, a perfect place for the pathogens to hide and reproduce and infect the area due to the lack of a good blood supply. It possible for some bone to form around the material, but the amount of bone on the implant surface will be limited. It is best to have living bone against the implant surface for all the reasons that living bone provides. Paul Carie is correct, the material can and will work out over the years, and once infected, it is a real PROBLEM. I feel it is best to use a material that will help the body to stimulate and regenerate real living bone. Also, why mix the a dense material with a product that will produce real bone. That would be like mixing rocks with good top soil for a garden.

Well said Don , coming from such a respected surgeon is interesting , I have been shown infected cases which can be alarming.

Dr. Callen, Well said!

PRP is also activated using Bovine Thrombine, which can cause an immunologic response.

I have bio oss attaching and spreading everywhere. Some has been taken out, the implant was taken out. I now have a glob of this garbage attached above #16, some in the soft palate by 16. Salty bitter taste coming from there as well. Do any of you folks know of someone who can remove some of these particles. My ENT just removed several pieces from my upper lip. The bio oss was originally placed in #14, obviously did not stay there. Cannot believe anyone in good conscience would use this stuff. Please let me know if any of you know of someone in your profession who would take this on.

Mr. Salzman, where are you located?

Dr. Hughes, I am in Palo Alto, California, but would travel anywhere to get this stuff taken out and this problem resolved. I realize that all of this stuff can never be removed, but would love to have someone at least help. Thank you for answering.

Mr. Salzman, You may want to visit Dr. Ralph Roberts in Rio Dell, Ca. or try the Dept. of Implant Dentistry at the Loma Linda Univ. School of Dentistry in southern California. I hope these approaches help! I am in Virginia.

Dr. Hughes, I will try the people you recommend, however, I do not mind traveling to Virginia if you think you could scrape some of this stuff out. I can point it out to you, there is a glob of it stuck on palatal side of bone that is a constant irritant. My dentist has also taken chunks of this migrating mess out, and is quite familiar with bio oss and all the reasons to never use it. Thank you again, David Salzman

John Peter, I do not have any fiancial interest in Osteogen. I think it's a wonderful product. I suggest that you read some literature on the topic, other than that from the rep or package insert. Even go back to review undergrag and basic science text. I suggest that you buy and reat the following: "Bone Graft Substitutes" edited by Cato T. Laurencin, M.D., Ph.D. You are supposed to be a man of science. Everybody has an opinion.

What are the chances of a reaction to BMP. I rec'd it 9/23 and 2 days later ended with swollen glands, severe sore throat. A few more days I then have "spots" all over the inside of my mouth! Yesterday, 10/01 the surgeon said "herpes"....... I'm married, 40 years, NEVER have had anything so can there be a connection? My tongue is bad, having a hard time swallowing again. Have another PCP appt today and hope to get the antibiotic for this. But there has to be a connection. If the BMP then it will come back. Any response from any doctors out there?

KAREN, BioOss can cause an allergic reaction. It's a bovine (cow) product that is very hard to breakdown. BMP and PRP can also cause allergic reactions. As for Herpes, it is ubiquitous, so don't worry about that. You were probably challenged to the max with the BioOss and or the BMP and the Herpes erupted.

Karen, The BioOss is hard to breakdown because of how it's processed and the particle size.

So, does this mean I'll continue to have problems with the BMP in my mouth? And what kind of allergic reactions have others experienced? I think I remember the surgeon saying this is from cadaver and not bovine. Supposed to be some sort of new "thing" to get my bone to grow. That's my understanding. PCP is sure it's herpes but the primary since I've never had anything like this before. Did a test which will confirm next week, am on antibiotics for this. Any chance the herpes will affect the bone graft or the 2 new implants? My story is a long one, lost upper teeth due to abuse at age 12, have had 13 "procedures" since Oct. '06 to try to give me bone and implants. I truly hope this works. I'm so discouraged as I had wanted a fixed prosthesis but with so many problems I'm afraid to risk another $25,000 to get the permanet thing. Just need to heal. And now this. Thank you for any response...... and sorry in advance for all the questions.

Karen, You are most likely out of the woods or will be soon with any allergic reaction. Now you have to give it tincture of time.

Dr Hughes I hope you will respond quickly to this! I've been having breakout since 9/28 with no improvement! I'm on the Acyclovir which I was told would stop any more new lesions after 72 hours and it's been since 10/2 morning and nothing. Please answer if I need to get this bio oss out???????? Is that the only way to stop this? I'm not doing any better and don't feel good either with this. The inside of my mouth is covered and today 10/6 I have new ones forming on the edge of my lips and they are swelling and hurt. Thanks

Karen, You may want to see an allergist and an infectious disease specialist. Ask the surgeon to check with the maker of BioOss and the BMP for any help! You have to determine if it's truely a Herpetic issus or an allergic reaction. You may also need a work-up for other immune issues, due to you and not the materials used.

Rec'd results. Negative. But surgeon said he's positive that it is Herpes no matter the culture taken. Will see PCP tomorrow. But today's appt with the OMS they gave me the product name Infuse Bone Graft from Medtronic and it's BMP and not bio oss. Guess there's a difference. Anyone know about BMP?

Karen, BMP can cause an inflammatory reaction. However, a reaction of this duration makes one wonder that something else is going on or there is some sort of immune issue that just reared it's ugly head. No pun intended. Unfortunately you are the one living with this. Your case is a good learning experience for those of us in practice. I hope you have a speedy and uneventful resolution.

I found this thread to be very interesting. Are people arguing that allergy to Bio-Oss is the reason for these failures or is it that Bio-Oss happens to have qualities that allow for infections (voids)that makes it a bad graft of choice? I don't know of any report to show bio-oss or other xenografts as creating an allergic response. We all know it takes longer to break down but that is often a desired quality. I sometimes use xenografts with good success and have not experienced any issues. Some of the patients reporting failures also leads me to believe the problems they are having are not associated with the graft but surgical complications. Once a graft is exposed and is moving around, it failed, and not because of the material. We all see complications and have to scoop out failed grafts but it's too easy to say it failed because of an allergic reaction. As someone discussed earlier if there is an allergic reaction going on, it may be from something else. I also tend to believe an oral surgeon when he thinks herpetic lesions are flaring up. Karen, I hope you keep updating us on your progress and we all wish you a speedy recovery. Amar

My current update and thank you to the doctors who respond. Found out not bio-oss but is Medtronic infuse bone graft rhBMP-2/ACS. Don't know what the end result will be for me but there has to be a connection that approx 52 hours after the new product is put in then the symptoms started. I finished a full 7 days antibiotic and within 2 days it's back. Not as bad as I'm using lots of vitamins, lysine etc. The PCP drew blood to check a couple of things so I will inform when I have the results. Anyone know of any problems with that product?

One more thing. I have rec'd a response from someone at Medtronic and the web site is www.infusebonegraft.com for anyone who wants to read the risks associated with the product.

Update on Herpes. It's confirmed that I do not have nor have I ever had Herpes. All the blood tests came back negative. The blood tests were to determine if I had antibodies and the final answer is NO. Today, Wed., I am seeing PCP who is going to do more cultures and blood tests as we have to find out what is causing this reaction! I have more "sores" in my mouth appearing again. The only thing different is the Medtronic Infuse Bone Graft (rhBMP-/ACS)put in Sept 23rd! Anyone out there who has experienced adverse reaction to this new product?

I feel like a "yo-yo" with this. Guess the one blood test proves never had Herpes but the second to determine if I've developed antibodies will be re-done. 3 drs insist it's Herpes so want me to wait for 28 days from exposure. What about an allergic reaction to the new implants? I'm getting worse again.

Oh my Gosh - I seem to have many similar symptoms as Karen with the sores and Herpes story. I am too worried about implants and bone and membrane the dentist put in and I have been going back and forth from dentist to doctor to dentist to doctor quite frequently since 9/24. How are you now Karen?

Andrea, I'm sorry that there's another person experiencing anything like this BUT...... The final determination from an ENT stated oral candida which looks just like herpes but totally different meds. I have never had herpes so every doctor said I still had it but it never responded to the Acyclovir. Or did a little but would always come back. Stress and antibiotics can bring on either one! So, look on the internet for "oral candida pictures" and you'll get an idea. If you've had Bio-Oss then contact the company and they'll respond to you and document your results! So, first get the name of the product, then the company and also pursue candida! Let me know how you are........... And Dr. Hughes on this thread will respond to you! Also, my allergy doctor said there is a possibility of allergic reaction to whatever the implant is made from. Should be titanium and he said THERE IS A TEST for it as opposed to some physicians saying there isn't. But he did say no one has tested positive in his practice yet and his clinic does most of the research trials for allergies/asthma........

It is not thrush or the like. I was told a dentist to go to an oral pathologist and that doctor will discover what the allergy could be related to - membrane or sutures or make/model of the implants. I never had "immune" issues or oral lesions until after had two dental implants. The ENT called me an "enigma" and told me to keep him posted. I was told to go to a neurologist for the facial pain. I have Acyclovir which seems to help with the "fire like" pain with the mouth sores. They move around and are also on the tongue. I now am beginning to itch and have more fire like pain in the sinus area. I had sinus series and that was ruled out. I just found the condition NCS Neurocutaneous Syndrome http://members.cox.net/llyee/ncs_diagnosis.htm yesterday. Like I tell all doctors/dentists, I don't want to go from doc to doc.. I rather spend my time doing fun stuff. But the mouth issues aren't getting better. All I want is to get fixed. I'm very afraid the sores will become visible instead of just inside. I'll ascertain what exactly what was put into my mouth at the time of the implants and will report later. It's very depressing. Thank you so much for your post. I am not alone. I am interested in anything that happens to you so I can find out how to make my life better.

I'll keep watching your posts and will keep you updated on me! I'm not 100% sure for me that it is the candida as it keeps coming back but your description of "on the tongue" etc describes me! I went to natural things to try to get it under control and it's helped ie Nancy's (brand) yogurt or any one that is natural with the acidolopilis (spelling?) etc. I will find the site for BioOss for you to contact them as well........ Implants are not w/o complications contrary to what we expect! I'll look at your site you posted

Today the sores came back in time for the ENT ... he biopsied it and thinks it could be lichen planus. I'll know results next week. In the meantime, he prescribed MethylPREDNIsolone tablets. I am so convinced it is something I had implanted at the time of the dental implants as I never had any such immune related issues prior. I'm hoping to get to the bottom of it and will keep looking for your posts. I meet with oral surgeon on January 11. Thanks Karen.

It's Thurs early morning, Andrea, so wanted to respond now! One doctor had me use Clotrimazole (Mycelex) lozenges which helped. This morning I now have a mouth full of sores as well so will go back on the lozenges. I understand your frustration as it's the same as mine. What a coincidence that I see my oral surgeon Jan 11, too! To Be Continued...............

I am experiencing exactly what was mentioned by the origional question...And I am not allergic to latex. 48 hours p bone graft, cadaver bone for dental inplant, I have developed R facial edema which is most noticable in the eye area along c uticaria.

I had cadaver bone for dental implant and some sort of "membrane" ... I'll ask the dentist who put the implants in to fax the chart to the oral surgeon. One way or another hopefully we can narrow it down. The ENT's biopsy came back - I don't have report in front of me, but he called today to say he's never seen anything like it - it is NOT HERPES, not cancer, chronic inflammation due to unknown reason, and to follow through with the oral surgeon. I'm hoping oral surgeon can distinguish if it is indeed an allergic reaction to one of the items put into my mouth, so we can take it out and let me heal.

Andrea, You may want to contact the FDA.

Dr. Hughes, I just now received the following information regarding what they put in my mouth at the time of the implants. Has it been any of your experience that any one of these products cause the symptoms described above: The bone grafting material that was used is a mixture of Puros and Gem 21 The membrane material is Cytoplast collagen The implants are as follows: Tooth #10 is a Nobel Biocare Select implant measuring 4.3x13mm. Lot # 669599 Ref 29414 Tooth #11 is a Nobel Tapered Groovy measuring 4.3x16mm. Lot # 671215 Ref 32218

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