The Journal of Bone & Joint Surgery

The Journal of Bone & Joint Surgery, Volume 88, Issue 9

Scientific Articles | September 01, 2006

Serum and Breast Milk Levels of Methylmethacrylate Following Surgeon Exposure During Arthroplasty

Colleen M. Linehan, MD¹; Terence J. Gioe, MD²

¹ Department of Orthopaedic Surgery, University of Minnesota, 2450 Riverside Avenue, Suite R200, Minneapolis, MN 55454. E-mail address: malek006@umn.edu
² Department of Orthopaedic Surgery, University of Minnesota, 17 West Exchange Street, St. Paul, MN 55102. E-mail address: tergioe@aol.com

View Disclosures and Other Information

In support of their research for or preparation of this manuscript, one or more of the authors received grants or outside funding from Stryker Howmedica. None of the authors received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, educational institution, or other charitable or nonprofit organization with which the authors are affiliated or associated.

Investigation performed at the Department of Orthopaedic Surgery, University of Minnesota, Minneapolis, Minnesota

The Journal of Bone and Joint Surgery, Incorporated

J Bone Joint Surg Am, 2006 Sep 01;88(9):1957-1961. doi: 10.2106/JBJS.F.00089

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Abstract

Background: Although pregnant personnel are commonly encouraged to leave the operating room during the mixing and application of polymethylmethacrylate, we are not aware of any information regarding the safety of exposure to methylmethacrylate fumes for breastfeeding women. The present study was performed to investigate the concentrations of methylmethacrylate in serum and breast milk following exposure during total joint arthroplasty.

Methods: A survey designed to determine present-day attitudes to polymethylmethacrylate exposure during pregnancy and lactation was sent to members of the Ruth Jackson Orthopaedic Society and the National Association of Orthopaedic Nurses. To define the presence or absence of a scientific basis for this behavior, serum and breast milk samples were collected from two lactating surgeons at selected intervals after exposure to methylmethacrylate during eight total joint arthroplasty procedures. Two healthy breastfeeding women without exposure to methylmethacrylate served as controls. All twenty-five samples were analyzed for methylmethacrylate with use of a previously published headspace gas chromatography protocol.

Results: The gas chromatography protocol detected methylmethacrylate at levels as low as 0.5 part per million. No serum or breast milk sample demonstrated evidence of methylmethacrylate at that level, nor did any surgeon sample test at a higher level than the control specimens. Serum and milk samples spiked with methylmethacrylate yielded the analyte peak as expected, evidencing no interference from either matrix.

Conclusions: Methylmethacrylate was not detectable at the 0.5-part-per-million level in serum or breast milk following inhalational exposure during total joint arthroplasty. Although a controlled longitudinal relative risk analysis was not performed and the sample size was relatively small, pregnant or breastfeeding women may use this information to make an informed decision regarding such exposure.

Level of Evidence: Therapeutic Level II. See Instructions to Authors for a complete description of levels of evidence.

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Sir John Charnley's pioneering research on the mechanical properties and systemic effects of polymethylmethacrylate was only one part of his body of work that paved the way for the era of modern total joint arthroplasty. In his landmark monograph on the subject of acrylic cement¹, Charnley made compelling arguments that polymethylmethacrylate is safe for patient use; however, little attention was given to the potential toxicity to surgical personnel resulting from exposure to the volatile acrylic monomer. Although polymethylmethacrylate has now been used extensively in orthopaedic applications for a half-century, numerous studies have demonstrated toxic effects of polymethylmethacrylate on various organ systems in laboratory animals exposed to extremely high doses^2-6. The acrylic monomer, an ester of methacrylic acid, has been shown to be the most dangerous ingredient².

In the early 1970s, Singh et al. studied the effects of methacrylic acid exposure in twenty gestational rats and noted dose-related embryonic-fetal toxicity and teratogenicity⁷. Although the adverse effects were only slightly worse than the findings in controls that had been exposed to normal saline solution (prevalence of skeletal abnormalities, 19% compared with 14%), this early study resulted in the virtual banishment of pregnant women from the operating room during the use of polymethylmethacrylate. The exposure route in that study was intraperitoneal injection of extremely high doses, which may not be relevant to surgeon exposure during arthroplasty procedures.

Despite the lack of conclusive evidence, pregnant operating room personnel are still often encouraged to leave the operating room during the mixing and application of polymethylmethacrylate. We are not aware of any information regarding the safety of polymethylmethacrylate exposure for lactating surgeons or operating room personnel. In fact, it is unknown whether methacrylic acid reaches detectable serum levels during inhalational surgical exposure. While it may be feasible for most ancillary operating room personnel to leave the operating room during cementation, this is not possible for the primary surgeon. The measurement of methacrylic acid levels in plasma and breast milk at selected increments after routine inhalational exposure during joint arthroplasty is possible with use of headspace gas chromatography. The purpose of the present study was to use such measurements to determine whether methacrylic acid is present in serum after exposure to environmental levels of acrylic monomer encountered during routine total joint arthroplasty and whether such inhalational exposure to methacrylic acid by lactating women leads to detectable levels of methacrylic acid in their breast milk.

Materials and Methods

Institutional review board approval and informed consent were obtained for this study.

Surgeon Survey

In an attempt to understand prevailing attitudes among women surgeons who are exposed to polymethylmethacrylate during pregnancy or lactation, a six-question e-mail survey was sent to members of the Ruth Jackson Orthopaedic Society (see Appendix). Of the 369 members on the e-mail list, eighty-nine (24%) responded. The survey was also sent to members of the National Association of Orthopaedic Nurses, but the nominal return rate precluded the use of their data.

Assay Methodology

After exposure to polymethylmethacrylate in the operating room during hybrid total hip arthroplasty (performed with use of an ingrowth cup and cemented stem) and total knee arthroplasty with cement, two healthy lactating orthopaedic surgeons (four to five months post partum) had their blood drawn as soon as the characteristic odor from the volatile vapors of methacrylic acid was no longer present^8,9. Seven total knee arthroplasties and one hybrid total hip arthroplasty were performed. Total knee arthroplasty was preferred as the study model because the surgeons were exposed in closer proximity to a greater surface area of cement than is the case during a total hip arthroplasty. In each case, two packs of Surgical Simplex P Bone Cement (Stryker, Mahwah, New Jersey) were mixed in a MIXEVAC II High-Vacuum Mixing System or Advanced Cement Mixing System (Stryker). A cement gun facilitated femoral canal cement implantation during total hip arthroplasty, and the cement was applied with a spatula from an open bowl during total knee arthroplasty. Although all procedures were performed in vertical laminar air-flow surgical suites, exhaust hoods were not worn by the operating room personnel.

All blood samples were immediately placed on ice and then were cold centrifuged for five minutes. Micropipettes were used to extract the serum, which was subsequently stored at —80°C in polypropylene tubes that were acrylic-free. Following completion of the operative procedure, the surgeons collected 30-mL breast milk samples with use of the acrylic-free Medela "Pump in Style" breast pump (Medela, McHenry, Illinois). These samples also were placed in polypropylene centrifuge tubes and were stored at —80°C. Additional breast milk samples were collected at six, seven to seventeen, and twenty-four hours postoperatively. During days with multiple exposures to polymethylmethacrylate, the surgeons collected serum and breast milk samples after each exposure, with additional breast milk samples at six, seven to seventeen, and twenty-four hours after the last exposure (Table I). No additional milk was expressed outside these intervals.

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TABLE I Specimen Collection Times of Surgeons A and B

	Surgeon A								Surgeon B
Procedure	Total Knee Arthroplasty	Total Knee Arthroplasty	Total Knee Arthroplasty	Hybrid Total Hip Arthroplasty	Total Knee Arthroplasty	Total Knee Arthroplasty	Total Knee Arthroplasty	Total Knee Arthroplasty
Date (d/mo/yr)	10/19/2004	10/21/2004	10/21/2004	10/26/2004	10/26/2004	10/26/2004	10/20/2004	10/25/04
Time*
Cement Start	0940	1109	1409	0951	1231	1529	0952	1153
Fumes Gone	1003	1122	1423	1007	1249	1540	1015	1216
Blood Drawn	1004	1124	1424	1008	1252	1542	1100	1236
Milk Sample 1	1045	1145	1440	1046	1304	1558	1130	1245
Milk Sample 2	1650		2245			2146	1745	N/A
Milk Sample 3†	2145		0145			1137	1145	1237
			(10/22/04)			(10/27/04)	(10/21/04)	(10/26/04)

The values are given as the time in hours and minutes, based on a twenty-four-hour clock, with 0000 representing 12:00 A.M. †The date is given in parentheses in cases in which the third sample was collected on the day after the procedure.

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TABLE I Specimen Collection Times of Surgeons A and B

	Surgeon A								Surgeon B
Procedure	Total Knee Arthroplasty	Total Knee Arthroplasty	Total Knee Arthroplasty	Hybrid Total Hip Arthroplasty	Total Knee Arthroplasty	Total Knee Arthroplasty	Total Knee Arthroplasty	Total Knee Arthroplasty
Date (d/mo/yr)	10/19/2004	10/21/2004	10/21/2004	10/26/2004	10/26/2004	10/26/2004	10/20/2004	10/25/04
Time*
Cement Start	0940	1109	1409	0951	1231	1529	0952	1153
Fumes Gone	1003	1122	1423	1007	1249	1540	1015	1216
Blood Drawn	1004	1124	1424	1008	1252	1542	1100	1236
Milk Sample 1	1045	1145	1440	1046	1304	1558	1130	1245
Milk Sample 2	1650		2245			2146	1745	N/A
Milk Sample 3†	2145		0145			1137	1145	1237
			(10/22/04)			(10/27/04)	(10/21/04)	(10/26/04)

The surgeons had no additional exposure to common everyday acrylic vapors (specifically, adhesives, glues, acrylic nails, or nail polish) outside of the operating room.

Two healthy lactating volunteer subjects with no documented inhalational exposure to polymethylmethacrylate or to common acrylic vapors served as controls. Two milk samples and one serum sample were collected from each control subject.

All twenty-five blood and breast milk samples were tested for methacrylic acid levels with use of headspace gas chromatography at an outside laboratory with special expertise in this area (Jordi FLP, Bellingham, Massachusetts). The analysis was run on a Hewlett-Packard 5890 Series II chromatograph equipped with a Flame Ionization detector attached to an HP 7694 headspace autosampler (Hewlett-Packard, Palo Alto, California). The test method was tuned for the target analyte with use of 99% methacrylic acid. Identical Surgical Simplex P Bone Cement, provided by Stryker, was used to generate the standards used in calibration. The gas chromatography protocol detected methacrylic acid at levels as low as 0.5 part per million, presently considered to be the industry standard. This external standard analysis was performed on an Alltech FFAP column (Alltech Associates, Deerfield, Illinois). Data were collected with use of ChromPerfect data acquisition and analysis software (version 5.0.0; Justice Laboratory Software, Denville, New Jersey). To confirm that the gas chromatography protocol could adequately detect methacrylic acid in serum and milk at 0.5 part per million, serum and milk samples were reanalyzed, spiked with known aliquots of methacrylic acid, and analyzed again. Statistical analysis was performed with SPSS software (version 12.0; SPSS, Chicago, Illinois). The level of significance was set at p < 0.05.

Results

No serum or breast milk sample demonstrated evidence of methacrylic acid at the 0.5-part-per-million level, nor did any surgeon sample test at a higher level than the control specimens. The spiked samples yielded the analyte peak of methacrylic acid as expected, evidencing no interference from either the serum or breast milk matrix.

Of the Ruth Jackson Orthopaedic Society survey respondents, 38% (twenty-one of fifty-five) scrubbed out during the cement phase of surgery while pregnant and 16% (eleven of sixty-nine) scrubbed out while breastfeeding. Nearly 80% (twenty-two of twenty-eight) indicated that this decision was based on "common knowledge" as opposed to review of the scientific literature. In addition, 65% (fifty-three of eighty-one) stated that they would feel comfortable remaining in the room during polymethylmethacrylate exposure while pregnant if they used a hooded exhaust system.

Paired Student t tests revealed no significant correlation between the responses to the above survey questions and age (thirty-five years or less compared with more than thirty-five years) or the geographical region of training/practice, with the numbers available.

Discussion

Although methylmethacrylate (methacrylic acid) toxicity has been studied since the 1940s, we are not aware of any information regarding the safety of exposure to methacrylic acid vapors for lactating surgeons. Most of the research in this area applicable to orthopaedic surgeons has centered on the possible teratogenic effects of methacrylic acid. Following the work by Singh et al., who reported dose-related teratogenic and fetal toxic effects of methacrylic acid administered via the intraperitoneal route in rats⁷, McLaughlin et al. reported the results of a study in which methacrylic acid was administered via a more applicable inhalation route in pregnant mice¹⁰. Pregnant mice were exposed to very high vapor concentrations of methacrylic acid of 1330 parts per million for two consecutive hours, twice daily. The mice demonstrated no evidence of fetal toxicity or teratogenic effects; in fact, there was a slight increase in fetal weight with methacrylic acid exposure.

Nicholas et al. subjected pregnant rats to "nose-only" inhalational exposure at 26,864 parts per million for 17.2 or 54.2 minutes¹¹. Compared with matched controls, the exposed rats exhibited decreased maternal weight and food consumption, decreased fetal weight and crown-rump length, early fetal deaths, and some gross and skeletal abnormalities. There were no differences in the number of fetuses per litter or in utero deaths with fetal resorptions. This embryonic-fetal toxicity and growth retardation are noteworthy but are not necessarily applicable to female surgeons with lower exposure levels. In their review of the literature, Solomon et al. pointed out that both the extremely high concentrations and the "nose-only" inhalational method would be expected to be stressful to pregnant rats¹². In their own study, 135 pregnant rats were exposed to varying concentrations (zero to 2028 parts per million) of inhaled methacrylic acid over daily six-hour intervals for nine days. Slight transient dose-related maternal toxicity was noted, but embryonic and fetal development was unaffected at all exposure levels, including those that were maternally toxic.

All of those experiments involved the use of relatively high vapor concentrations of methacrylic acid. As a point of reference, the breathing zone concentration of methacrylic acid identified by McLaughlin et al. during three total hip arthroplasties never increased above 280 parts per million¹⁰. Similarly, Darre et al. found surgeon breathing zone concentrations of fifty to 100 parts per million during cementation of the acetabular component¹³. This level was reduced to zero when the surgeon wore the Stackhouse FreedomAire Surgical Helmet System (Stackhouse, Wheeling, Illinois). Cloft et al.¹⁴ measured average exposure during one-hour vertebroplasty procedures and found it to be under the detection limit of five parts per million in the ten samples measured.

Industrial and governmental studies of inhalational methacrylic acid exposure during various manufacturing processes appear to support a recommended standard exposure level of 100 parts per million as a time-weighted average for an eight-hour workday^15,16. Given the average exposure time to methacrylic acid vapors during arthroplasty and the discontinuous nature of surgical procedures performed on the same day, it is unlikely that this level is reached for operating room personnel.

To our knowledge, the only published study that has addressed methacrylic acid exposure during lactation involved a patient undergoing arthroplasty, not operating room personnel who were exposed to methacrylic acid vapors¹⁷. In that study, Hersh et al. found undetectable levels of polymethylmethacrylate in breast milk that was collected thirty-six hours after hybrid total hip arthroplasty in a twenty-nine-year-old woman who was five months post partum. Serum levels were not measured. Wenda et al. demonstrated rapid elimination of methacrylic acid in the serum during its first passage through the lungs¹⁸. The present study showed undetectable levels of methacrylic acid (at the 0.5-part-per-million level) in the serum and breast milk of two lactating surgeons who had been exposed to typical operating room conditions without the use of personal exhaust systems. The present study was based on the realistic expectations of breastfeeding surgeons or operating room personnel. It may be difficult for surgeons to pump breast milk at precise intervals because of their fluctuating schedules and work demands. The surgeons in the present study collected samples that were structured but also realistic and compatible with their duties.

The limitations of the present study include the relatively small number of subjects, the sampling methodology, and the relatively short time-frame of collection. We were unable to recruit any other lactating surgeons during our enrollment period. Sampling the serum during the methacrylic acid exposure would have given us additional information, but radial artery and pulmonary artery cannulization of the surgeon is impractical at best. Levels of methacrylic acid may exist in serum or breast milk below the detectable level of 0.5 part per million, but this exceeds current measuring capabilities. It is possible that more cases evaluated over a longer period of time could show a cumulative effect in breast milk, but this seems unlikely given the rapid pulmonary clearance of methacrylic acid and the nature of the matrix of breast milk itself¹⁹. Measurement of breathing zone concentrations of methacrylic acid in the operating room may also have been beneficial, but this requires an elaborate sampling apparatus that was unavailable to us.

Both our relatively simple survey and the responses that many female surgeons provided (see Appendix) indicated that exposure to methacrylic acid vapors while pregnant or lactating is still an issue that is clouded by uncertainty and emotion. Although we cannot offer a comprehensive recommendation at this time on the basis of the current literature and the results of our study, the subjects of this report are comfortable with intraoperative methacrylic acid inhalational exposure during lactation. A further level of assurance is offered by the findings of Darre et al., who demonstrated the ability to lower breathing zone concentrations to nearly zero with a personal exhaust system, which is used by many orthopaedists during total joint arthroplasty¹³.

Appendix

Tables showing the survey and surgeon's comments derived from the survey are available with the electronic versions of this article, on our web site at (go to the article citation and click on "Supplementary Material") and on our quarterly CD-ROM (call our subscription department, at 781-449-9780, to order the CD-ROM). ?

Acknowledgements

Note: The authors thank Paul Morse of Jordi FLP for his expertise in headspace gas chromatography; Dr. Amy Lelwica, University of Minnesota, for her ongoing contributions to the study; the Ruth Jackson Orthopaedic Society for their assistance in conducting our survey; and Steven Carmella, University of Minnesota, for his guidance in determining our methodology.

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McLaughlin RE, DiFazio CA, Hakala M, Abbott B, MacPhail JA, Mack WP, Sweet DE. Blood clearance and acute pulmonary toxicity of methylmethacrylate in dogs after simulated arthroplasty and intravenous injection. J Bone Joint Surg Am. 1973;55: 1621-8.551621 1973 [PubMed]

Spealman CR, Main RJ, Haag HB, Larson PS. Monomeric methyl methacrylate. Am J Ind Med. 1945;14: 292-8.14292 1945

Homsy CA, Tullos HS, King JW. Evaluation of rapid-cure acrylic compound for prosthesis stabilization. Clin Orthop Relat Res. 1969;67: 169-71.67169 1969

Wiltse LL, Hall RH, Stenehjem JC. Experimental studies regarding the possible use of self-curing acrylic in orthopaedic surgery. J Bone Joint Surg Am. 1957;39: 961-72.39961 1957 [PubMed]

Singh AR, Lawrence WH, Autian J. Embryonic-fetal toxicity and teratogenic effects of adipic acid esters in rats. J Pharm Sci. 1973;62: 1596-600.621596 1973 [PubMed][CrossRef]

Lee AJ, Ling RS, Wrighton JD. Some properties of polymethylmethacrylate with reference to its use in orthopaedic surgery. Clin Orthop Relat Res. 1973;95: 281-7.95281 1973 [PubMed]

Lee AJ, Ling RS. Further studies of monomer loss by evaporation during the preparation of acrylic cement for use in orthopaedic surgery. Clin Orthop Relat Res. 1975;106: 122-5.106122 1975 [PubMed][CrossRef]

McLaughlin RE, Reger SI, Barkalow JA, Allen MS, Difazio CA. Methylmethacrylate: a study of teratogenicity and fetal toxicity of the vapor in the mouse. J Bone Joint Surg Am. 1978;60: 355-8.60355 1978 [PubMed]

Nicholas CA, Lawrence WH, Autian J. Embryotoxicity and fetotoxicity from maternal inhalation of methyl methacrylate monomer in rats. Toxicol Appl Pharmacol. 1979;50: 451-8.50451 1979 [PubMed][CrossRef]

Solomon HM, McLaughlin JE, Swenson RE, Hagan JV, Wanner FJ, O'Hara GP, Krivanek ND. Methyl methacrylate: inhalation developmental toxicity study in rats. Teratology. 1993;48: 115-25.48115 1993 [PubMed][CrossRef]

Darre E, Jorgensen LG, Vedel P, Jensen JS. Breathing zone concentrations of methylmethacrylate monomer during joint replacement operations. Pharmacol Toxicol. 1992;71: 198-200.71198 1992 [PubMed][CrossRef]

Cloft HJ, Easton DN, Jensen ME, Kallmes DF, Dion JE. Exposure of medical personnel to methylmethacrylate vapor during percutaneous vertebroplasty. AJNR. Am J Neuroradiol. 1999;20: 352-3.20352 1999 [PubMed]

US Environmental Protection Agency. Toxicological review of methyl methacrylate. (CAS No. 80-62-6). In support of summary information on the integrated risk information system (IRIS). Research Triangle Park, NC; National Center for Environmental Assessment, Office of Research and Development, 1998. 1998

American Conference of Governmental Industrial Hygienists. Threshold limit values for chemical substances and physical agents. Cincinnatti, OH: ACGIH Worldwide; 1996: 112.112 1996

Hersh J, Bono JV, Padgett DE, Mancuso CA. Methyl methacrylate levels in the breast milk of a patient after total hip arthroplasty. J Arthroplasty. 1995;10: 91-2.1091 1995 [PubMed][CrossRef]

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Topics

methylmethacrylate ; milk, human ; operating room ; polymethyl methacrylate ; arthroplasty

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Colleen M. Linehan, Terence J. Gioe; Serum and Breast Milk Levels of Methylmethacrylate Following Surgeon Exposure During Arthroplasty. The Journal of Bone & Joint Surgery. 2006 Sep;88(9):1957-1961.

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