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104-533: The test claimed that it offered an alternative to amniocentesis and ultrasound . Gender Mentor claimed that women had many motivations for using the test to learn the sex of their fetuses early in pregnancy, including mental preparation and planning gender-specific purchases, or more controversially, sex-selective abortion . Customers and scientists have questioned the accuracy of the test. Legal actions were taken against Acu-Gen and their supplier. The lawsuits claimed that Acu-Gen's products do not accurately predict

208-686: A case involving a vanishing twin. The PregnancyStore.com states that none of the refund checks were issued as a result of the test being proven wrong by a live birth . Their website states: To date, Acu-Gen has issued 200% refund checks to a few customers—NOT for incorrectly identifying the baby's gender at birth, though. Two are for cases involving vanishing twins, one case due to insufficient blood sample, two cases caused by incomplete reactions and three reversal cases of no obvious reasons. All of these eight cases are currently in their second trimester of pregnancy. In March 2006, Wang wrote in an e-mail to NPR, he has "decided to defer all his energies regarding

312-464: A certain possibility, that her fetus has a kind of genetic problem. Of course later on, we had used our technology to prove that she has a chromosome problem: Trisomy 18 . That means that this baby [is] going to have a developmental problem and is going to probably cease to exist right after the birth." Dr. Diana Bianchi of Tufts disputes the possibility of the test being used for such a diagnosis. She says, "The test involves looking at genetic sequences on

416-483: A condition known as Rhesus disease or hemolytic disease of the fetus and newborn. Maternal blood type is assessed prior to undergoing amniocentesis and RhD immune globulin (RhoGam) is typically administered within 72 hours of the procedure to prevent maternal Rh sensitization in RhD negative patients that are non-sensitized to RhD antigens. Amniotic fluid embolism, a condition in which amniotic fluid or other fetal debris enters

520-718: A consequence of bleeding, infection, or trauma to the fetus or the amniotic sac as a result of the procedure. Studies from 2000 to 2006 estimated the procedure-related pregnancy loss at 0.6-0.86%. The most recent systematic review of the literature and updated meta-analysis on the risk of pregnancy loss following amniocentesis was published in 2019. This study cites the amniocentesis-related pregnancy loss to be 0.30% (95% CI, 0.11–0.49%). The incidence of amniocentesis-related complications, including pregnancy loss and procedure failure, may be mitigated when performed by experienced practitioners who complete 100 or more amniocenteses per year. Experienced practitioners are more likely to complete

624-408: A default rule, the perfect-tender rule may be "contracted around" in ways that specify or limit a buyer's remedies (and that accordingly reduce the market price that rational buyers are willing to pay for the goods). In many cases, the vendor will not provide a refund but will provide store credit . In the cases of software , movies , and other copyrighted material, many vendors will offer only

728-440: A direct exchange for another copy of the same title, with the effect that the initial transfer or license of intellectual-property rights is preserved. Most stores require proof of purchase and impose time limits on exchanges or refunds. Some larger chain stores , such as F.Y.E. , Staples , Target , or Walmart , will, however, do exchanges or refunds at any time, with or without proof of purchase, although they usually require

832-512: A disease. The company was not obliged to disclose results of tests. Acu-Gen listed studies related to detecting fetal blood cells present in maternal circulation, but studies did not refer specifically to the Baby Gender Mentor test. The company claimed that their kit could detect twins. The test was featured on an episode of The Today Show in June 2005. In that show, Katie Couric interviewed

936-431: A family or suspected based on fetal ultrasound findings, such as sickle cell disease , Tay–Sachs disease , neurofibromatosis , and cystic fibrosis . Amniocentesis has traditionally been performed to assess the extent of fetal lung development in the context of medical and obstetrical complications, with the intention of delivering the fetus if fetal lung maturity is demonstrated. Lack of fetal lung maturity increases

1040-664: A fetus or destruction of an embryo. In addition, the use of embryonic cells has been shown to develop into tumors such as teratocarcinomas and frequently acquire chromosomal errors, underscoring the benefits of utilizing amniotic stem cells. Research has shown that cells from second trimester amniotic fluid are successful at differentiating into various cell lines. Artificial heart valves, working tracheas, as well as muscle, fat, bone, heart, neural and liver cells have all been engineered through use of amniotic stem cells. Tissues obtained from amniotic cell lines show significant promise for patients with congenital diseases/malformations of

1144-451: A fever greater than 38 °C. Caveat emptor Caveat emptor ( / ˈ ɛ m p t ɔːr / ; from caveat , "may he/she beware", a subjunctive form of cavēre , "to beware" + ēmptor , "buyer") is Latin for "Let the buyer beware". It has become a proverb in English. Generally, caveat emptor is the contract law principle that controls the sale of real property after

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1248-570: A form of picture identification and place per-transaction and/or per-person quantity or dollar limitations on such returns. In the UK, consumer law has moved away from the caveat emptor model, with laws passed that have enhanced consumer rights and allow greater leeway to return goods that do not meet legal standards of acceptance. Consumer purchases are regulated by the Consumer Rights Act 2015 , whilst business-to-business purchases are regulated by

1352-815: A genetic disorder, prior child with a structural birth defect, previous fetus or child with autosomal trisomy or sex chromosome aneuploidy, ultrasonographic evidence of a fetus with structural abnormalities, and a high-risk genetic screening test result. Analysis of samples obtained from amniocentesis is accomplished via karyotyping and DNA analysis technology. Examples of conditions that may be detected include chromosomal abnormalities such as common aneuploidies like trisomy 13 , trisomy 18 , trisomy 21 , Turner syndrome , and Klinefelter syndrome . Micro-deletions or micro-duplications, such as DiGeorge syndrome and Cri-du-Chat syndrome , sex-linked disorders, such as hemophilia and Duchenne muscular dystrophy , and specific genetic mutations previously demonstrated to be present in

1456-466: A higher risk of complications if they undergo amniocentesis and should be counseled appropriately. In some cases, the advantages of obtaining the results of an amniocentesis may outweigh the increased risk of complications. Patients on oral anticoagulation therapy have an increased risk of bleeding from the procedure and may be switched to low-molecular-weight heparin , which carries a lower risk for bleeding complications, prior to amniocentesis. There

1560-511: A mixed sex set of fraternal twins, so the test should have predicted twins instead of predicting a single baby whose sex turned out to be incorrect. With Acu-Gen choosing not to publish proof of its claims and evidence of several women receiving inaccurate predictions, doctors are concerned about the test. Among the scientific evidence cited by Acu-Gen's website is a paper co-authored by Diana Bianchi, an expert on fetal DNA at Tufts University . The NPR story quoted Bianchi as saying, "I think at

1664-471: A process in which maternal antibodies form against red blood cell Rh antigens. Events causing fetomaternal hemorrhage , such as miscarriage , trauma to the abdomen during pregnancy, ectopic pregnancy , induced abortion , invasive pregnancy procedures, labor, and birth can lead to fetal Rh positive red blood cells entering the Rh negative maternal circulation. Rh sensitization typically does not cause problems during

1768-539: A result of bacterial introduction throughout the course of the procedure. The risk of amniocentesis-related chorioamnionitis and uterine infections is less than 0.1%. Performing the procedure using sterile techniques can help prevent infection. Fetomaternal hemorrhage, or the entrance of fetal blood into the maternal circulation, is another complication of amniocentesis. It can result in anemia that can have consequences of varying severity. The procedure-related risk of fetomaternal hemorrhage attributable to amniocentesis

1872-667: A result turnaround of up to three weeks. Another test that may be performed is a chromosomal microarray, which can detect chromosomal imbalances, such as small- and large-scale deletions and duplications. Chromosomal microarray can be performed on cultured or uncultured fetal tissue, with results available as early as 3 days. The American College of Obstetricians and Gynecologist recommends that patients who choose to undergo invasive diagnostic testing have access to chromosomal microarray analysis. After an amniocentesis, patients may resume their routine activity level while withholding from strenuous exercise. Some sources recommend house rest for

1976-416: A result, patients with rhesus (RhD) negative blood types carrying a RhD positive fetus are at risk of Rh sensitization. Rh sensitization is a process in which maternal antibodies form against red blood cell RhD antigens. In subsequent pregnancies with RhD positive fetuses, maternal presence of these antibodies can attack and destroy fetal red blood cells, a process called Rh isoimmunization that can result in

2080-495: A safe and accurate procedure. The risks and complications associated with amniocentesis include pregnancy loss, preterm labor and delivery, preterm premature rupture of membranes (PPROM), fetal injuries, Rhesus disease , and amniotic fluid embolism . Oligohydramnios, fetomaternal hemorrhage , cell culture failure, multiple amniotic fluid extraction attempts, and infections are also possible complications. Additional maternal complications include vaginal bleeding, hematoma of

2184-462: A shared-decision-making process that takes into account a patient's individual risk profile and preferences. Amniocentesis may be offered to certain patients at higher risk of having a fetus with a genetic disorder. Factors that may place patients at increased risk of fetal genetic disorders include older maternal or paternal age, parental carrier of a balanced chromosomal rearrangement, parental aneuploidy or aneuploidy mosaicism , parental carrier of

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2288-462: A single placenta develop significant vascular cross-connections, known as anastomoses , resulting in blood flowing away from one twin to the other. This process can result in polyhydramnios in one twin and oligohydramnios in the other twin. Amniocentesis has been employed to reduce the volume in the sac with polyhydramnios in order to relieve amniotic fluid pressures, a process that may improving fetal circulation and outcomes. Amniotic fluid, which

2392-501: A specific sex will be learning the results at a time when it is safer for them to have an abortion, without the complications associated with aborting later in pregnancy. Some bioethicists believe that sex selection is an ethical problem and could be disruptive to society. Charles Lockwood of Yale says, "a disproportionate number of female fetuses have been terminated worldwide, and a 2-to-1 male-to-female ratio could lead to social unrest and wars." According to Arthur Caplan , director of

2496-636: A spokesperson for the Illinois State Attorney General , says that they are investigating PregnancyStore.com for possible fraud . No fraud charges were ever made against PregnancyStore.com. Florida Congressman Jim Davis has urged the FDA to investigate Acu-Gen, and the Florida Attorney General has opened an investigation against Acu-Gen. A law firm named Gainey & McKenna has filed a class action lawsuit and at least one other firm

2600-464: A statutory "cooling off" period of fourteen calendar days during which the purchase contract can be cancelled and treated as if not done. Although no longer applied in consumer law, the principle of caveat emptor is generally held to apply to transactions between businesses unless it can be shown that the seller had a clear information advantage over the buyer that could not have been removed by carrying out reasonable due diligence . Caveat venditor

2704-488: A woman named Holly Osburn who was mother to two daughters and expecting. Osborn said that she wanted to know the gender because she wanted to paint the nursery blue. Sherry Bonelli, the CEO of PregnancyStore.com was also interviewed and said that the test had only been available for two weeks and that numerous people had inquired about it in a short time. She also said that Acu-Gen had followed 2,000 pregnancies through to birth and that

2808-456: Is Latin for "let the seller beware." In the landmark case of MacPherson v. Buick Motor Co. (1916), New York Court Appeals Judge Benjamin N. Cardozo established that privity of duty is no longer required in regard to a lawsuit for product liability against the seller. This case is widely regarded as the origin of caveat venditor as it pertains to modern tort law in US. Caveat lector

2912-640: Is not a substitute for medical or professional care. If you have, or you suspect that you or your baby may have, a health condition or illness, you should consult with your doctor. Never disregard medical or professional care or advice or delay seeking it because of something you have learned from Acu-Gen, the Baby Gender Mentor Test or our Web Site. Except for the specific information contained on our Web Site, you cannot and should not rely on any information provided by Acu-Gen, Acu-Gen employees or other visitors to our Web Site. The content of our Web Site

3016-431: Is sampled and analyzed via methods such as karyotyping and DNA analysis technology for genetic abnormalities. An amniocentesis is typically performed in the second trimester between the 15th and 20th week of gestation. Women who choose to have this test are primarily those at increased risk for genetic and chromosomal problems, in part because the test is invasive and carries a small risk of pregnancy loss . However,

3120-647: Is 2.6%. Amniotic fluid cell culture after amniocentesis has a failure rate of 0.1%. Later gestational ages at the time of the procedure and amniotic fluid samples contaminated with blood increase the risk of amniocyte culture failure. While recognizing the aforementioned risks, the American College of Obstetricians and Gynecologists recommend that prenatal screening, or diagnostic testing for aneuploidy via procedures like amniocentesis or chorionic villus sampling, be discussed with and offered to all patients regardless of maternal age or risk profile. An amniocentesis

3224-502: Is a biotech company in Lowell, Massachusetts and is led by Chang-ning Wang, the company's President. A National Public Radio reporter visited the address given as the headquarters of Acu-Gen in September 2005. They found that the building at that address contains a Hindu temple and a company called BioTronics , but no sign for Acu-Gen. According to NPR, their inquiries at BioTronics revealed

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3328-454: Is administered to prevent maternal Rh sensitization in Rh negative patients that are non-sensitized to Rh antigens. In the past, serial amniocenteses has been used to monitor isoimmunized pregnancies by measuring the levels of bilirubin, a byproduct of red blood cell breakdown, present in amniotic fluid using spectrophotometry . However, ultrasound detecting middle cerebral artery peak systolic velocity has now replaced serial amniocenteses for

3432-418: Is an increased risk of mother-to-child ( vertical) transmission of bloodborne infections in patients with hepatitis B, hepatitis C, or HIV after amniocentesis. Patients with high viral loads are at a greater risk of vertical transmission of hepatitis B compared to patients with low viral loads. In patients living with HIV, amniocentesis should be deferred until a combined antiretroviral therapy (CART) regimen

3536-421: Is an inherited protein found on the surface of red blood cells. If the mother is Rh negative and the father is Rh positive, a fetus has at least a 50% chance of being Rh positive. Rh incompatibility occurs when a mother has Rh-negative blood and her baby has Rh-positive blood. If the red blood cells of an Rh positive fetus cross into their Rh negative mother's blood flow, the mother is at risk of Rh sensitization,

3640-407: Is capable of providing a limited karyotype and, along with the aforementioned trisomies, can also detect aneuploidies in the X and Y sex chromosomes. Abnormal results from FISH studies should be confirmed with other cytogenetic testing , as false positives and negatives are possible Karyotypes are another common test performed on amniotic fluid to visualize chromosome number and characteristics, with

3744-437: Is critical of the kits. Acu-Gen's website states the test was not a medical test: Acu-Gen Biolab, Inc. ("Acu-Gen") and the www.babygendermentor.com website ("Web Site") do not offer medical advice or professional services. The products and information provided with the Baby Gender Mentor Test cannot and should not be used for diagnosing or treating a known or suspected health condition or illness. The Baby Gender Mentor Test

3848-442: Is easily collected, cultured, and stored through cryopreservation, can be a rich source of pluripotent and multipotent mesenchymal , hematopoietic , neural , epithelial , and endothelial stem cells . A potential benefit of using amniotic stem cells over those obtained from embryos is that they address the ethical concerns among anti-abortion activists by obtaining pluripotent lines of undifferentiated cells without harm to

3952-481: Is established and the patient achieves a low or undetectable viral load. While not a contraindication, an amniocentesis may be postponed if fusion of the amnion and chorion has not yet occurred. Performing an amniocentesis prior to the fusion of the amnion and chorion is more likely to lead to procedure failure that may require further sampling attempts. Amniocentesis performed for the purpose of prenatal diagnostic testing for genetic disorders has been established as

4056-412: Is intended to identify patients who are at increased risk of having a fetus with a genetic condition while prenatal genetic diagnostic testing detects whether a specific genetic condition is present in the fetus with high accuracy. Amniocentesis, along with chorionic villus sampling , are examples of prenatal diagnostic tests. Amniocentesis or chorionic villus sampling is necessary to conclusively diagnose

4160-477: Is inviting people to contact them about their legal rights if they are unhappy with the results of their test. Gainey & McKenna's lawsuit seeks to bar the company from false advertising in marketing its test and to compel the firm to honor its money-back guarantee. The law firm cites seven areas of contention, including the veracity of the accuracy claims and the violation of HIPAA and other laws. Parents have cited an interest in preparing themselves or

4264-757: Is less than the minimum expected for gestational age. Adequate amniotic fluid volumes are essential for fetal lung development. Therefore, possible consequences of oligohydramnios include infant respiratory distress and small, underdeveloped lungs known as fetal lung hypoplasia. Needle injuries to the fetus are increasingly rare due to the practice of using continuous ultrasound-guidance, including during needle insertion and amniotic fluid extraction. Reported needle injuries include cord bleeding, ocular injuries, fetal brain and cutaneous injuries, and deformities such as clubfoot. The risk of fetal injury increases with increasing number of puncture attempts. Maternal and fetal blood cells may mix during an amniocentesis and, as

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4368-494: Is not a stringent indication for prompt delivery." Based on this rationale, the risks associated with amniocentesis, and the limited indications, performing amniocenteses for assessing fetal lung maturity may become obsolete except in instances where gestational age is unknown. Chorioamnionitis , or intraamniotic infection, is an infection of any combination of the amniotic fluid, placenta , fetus , fetal membranes , or decidua . The gold standard for diagnosing chorioamnionitis

4472-431: Is not responsible for any consequences resulting from failure to follow kit instructions. To claim the refund, the birth certificate should include BOTH the address and name of the purchaser. In some instances, Baby Gender Mentor may request the finger press of the baby to conclude the refund process... PregnancyStore.com also updated their website to state that the warranty was only 100% of the purchase price. In July 2006,

4576-555: Is provided on an "as is" basis. Tests similar to the Baby Gender Mentor test can be used for medical diagnoses. For instance, scientists have shown that it is possible to use fetal DNA from a woman's blood to screen the fetus for genetic defects such as Down syndrome . In a validation study sponsored by the National Institute for Child Health and Development, 5 different labs used fetal cells from maternal blood to search for evidence of Down syndrome in 2,744 pregnancies. On average,

4680-416: Is submitted for laboratory testing. Fetal viability after the procedure should be confirmed by observing adequate fetal cardiac activity. The number of needle puncture attempts should be documented. There is little scientific data supporting administration of prophylactic antibiotics prior to an amniocentesis and therefore, it is currently not recommended. Similarly, there is little scientific support for

4784-430: Is through a legally binding warranty , such as a guarantee of satisfaction . Under the principle of caveat emptor , the buyer could not recover damages from the seller for defects on the property that rendered the property unfit for ordinary purposes. The only exception was if the seller actively concealed latent defects or otherwise made material misrepresentations amounting to fraud . Before statutory law ,

4888-413: Is typically performed in the second trimester between the 15th and 20th week of gestation; however, it can be done at any later gestational age. It is an outpatient procedure typically performed by an obstetrician-gynecologist with additional amniocentesis training. Genetic counseling should be provided to the pregnant patient and informed consent should be obtained prior to the procedure. Prior to

4992-490: Is via a gram stain, glucose level, or culture of the amniotic fluid obtained via amniocentesis. However, in clinical practice, performing an amniocentesis for the purpose of diagnosing chorioamnionitis is rare and instead diagnosed based on clinical signs to ensure prompt treatment and avoid invasive prenatal testing. Amniocentesis can be used to detect other congenital infections such as cytomegalovirus , hepatitis B , parvovirus B19 , and toxoplasmosis . The Rh factor

5096-600: The Center for Bioethics at the University of Pennsylvania , sex selection is not a frequent occurrence in the United States but it is a concern in countries such as India and China, where having boys is preferred over having girls. In China, sex selection has led to men outnumbering women by about 105-to-100. In India, the ratio of girls to boys is also on the decline. The 2004 census shows that there were 818 girls born per 1,000 boys;

5200-504: The Sale of Goods Act 1979 . In the UK, consumers have the right to a full refund for faulty goods. However, traditionally, many retailers allow customers to return goods within a specified period (typically two weeks to two months) for a full refund or an exchange, even if there is no fault with the product. Exceptions may apply for goods sold as damaged or to clear. Goods bought through "distance selling," for example online or by phone, also have

5304-470: The X chromosome and the Y chromosome. If he gave a diagnosis of Trisomy 18, that involves a different chromosome, Chromosome 18 . That is certainly something that is not advertised in the packaging associated with the test. "It is possible that, upon being told of a problem by Acu-Gen, a woman may seek to have an amniocentesis or other invasive procedure which may be an unnecessary risk if the Acu-Gen diagnosis

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5408-478: The implied warranty of fitness for a particular purpose applies in the real-estate context to only the sale of new residential housing by a builder-seller and that the caveat emptor rule applies to all other real-estate sale situations (e.g. homeowner to buyer). Other jurisdictions have provisions similar to this. Under Article 2 of the Uniform Commercial Code , the sale of new goods is governed by

5512-420: The "perfect-tender" rule unless the parties to the sale expressly agree in advance to terms equivalent to caveat emptor (such as describing the goods as sold "as is" and/or "with all faults") or other limitations such as the below-discussed limitations on remedies. The perfect-tender rule states that if a buyer who inspects new goods with reasonable promptness discovers them to be "nonconforming" (failing to meet

5616-559: The American College of Obstetricians and Gynecologists and other similar professional associations recommend against undergoing amniocentesis prior to 14 weeks' gestation. In the past, twin pregnancies have been noted to have a higher rate of pregnancy loss (estimated at 3.07%) following amniocentesis. Past literature has shown that twin pregnancies increase the background risk of fetal loss following amniocentesis before 24 weeks' gestation by 1%. Although data on complications following amniocentesis in twin pregnancies continues to be limited,

5720-565: The American College of Obstetricians and Gynecologists note that rate of pregnancy loss due to amniocentesis in this population is estimated to be around 2%. A 2020 systematic review and meta-analysis showed similar findings, noting that pregnancy loss following amniocentesis may be lower than previously reported in twin pregnancies. The study also found no significant difference in rates of pregnancy loss between twin pregnancies that underwent amniocentesis and those that did not before 24 weeks of gestation. Maternal factors that may further increase

5824-433: The American College of Obstetricians and Gynecologists recommends that all women be offered prenatal assessment for aneuploidy , or the presence of an abnormal number of chromosomes, by either genetic screening or diagnostic testing independent of maternal age or risk factors. There are relative contraindications to performing an amniocentesis, however no absolute contraindications have been identified. Physicians have used

5928-465: The BGM product and service for one more year, when results of actual births compared to the results provided by Baby Gender Mentor should answer any concern about the accuracy of the test." Initial news reports and the Acu-Gen website touted a 200% money-back guarantee. In May 2006, the Baby Gender Mentor website was modified to show a different warranty than the one that had originally promised to refund 200% of

6032-487: The Baby Gender Mentor website. A news crew from television station WFTS , an American Broadcasting Company (ABC) affiliate, visited the Acu-Gen offices in February 2006. They found "about six employees inside Wang's lab, some putting together sex test kits, others doing some type of lab work. There was a room full of machines Chang said he created, and shelves stacked with blood samples supposedly sent in by women from across

6136-566: The PregnancyStore.com reported that the test was "currently out of stock", and In-Gender.com, a commercial sales blog, reported that the test has been completely pulled from the market in India. As of January 2007, PregnancyStore.com no longer contains any mention of the kit on their website, although the BabyGenderMentor.com website does contain a form for on-line purchasing of the kit. Acu-Gen

6240-567: The United States." BioTronics does make a laboratory instrument known as an AG-9600 AmpliSensor Analyzer, which is used for quantitative DNA analysis. It is not known whether the two journalists visited the same address, nor is it known whether Acu-Gen and BioTronics currently share office or laboratory space. As of January 2007, Acu-Gen lists their address as "50 Stedman Street, Lowell, MA". On December 2, 2006 BioTronics' trademark on "AmpliSensor" (U.S. trademark registration number 1958576)

6344-474: The assessment of fetal lung maturity has been called into question. The Eunice Kennedy Shriver National Institute of Child Health and Human Development and the Society for Maternal-Fetal Medicine's joint statement on the matter states that "if significant maternal or fetal risks exist, delivery should occur regardless of biochemical maturity and if delivery could be deferred owing to absence of pulmonary maturity there

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6448-472: The baby's siblings for gender-specific issues. Some women might prefer this test to an ultrasound exam, which might reveal fetal abnormalities that the parents might prefer not to know about until after delivery. The National Public Radio investigative report on Acu-Gen predicted that parents may use the Baby Gender Mentor test as a basis for determining whether to get a sex-selective abortion . KMSP-TV interviewed genetic counselor Dr. Analia Bortz who made

6552-633: The boxes shipped to early customers, but the requirements have since appeared on Acu-Gen's website. Gainey has filed a class action lawsuit on behalf of 40 people who claim they received inaccurate results but were unable to obtain refunds from Acu-Gen. There have been conflicting reports about how often the company has refunded money to consumers who received an erroneous result with the test. In February 2006, Wang said, "We don't mistakes [ sic ]. Period." Yet in October 2005 he had stated his company had issued four refund checks, including one for

6656-403: The buyer had no express warranty ensuring the quality of goods. In the UK, common law requires that goods must be "fit for the particular purpose" and of "merchantable quality", per Section 15 of the Sale of Goods Act but this implied warranty can be difficult to enforce and may not apply to all products. Hence, buyers are still advised to be cautious. The modern trend in the U.S. is that

6760-399: The chorion and amnion should be fused. Amniocentesis is a sterile procedure, therefore medical personnel performing and assisting with the procedure will scrub with antiseptic solution, use sterile gloves, clean the maternal abdomen with antiseptic solution, cover the ultrasound probe with a sterile cover, and use sterile ultrasound gel. Ultrasound guidance is used continuously throughout

6864-452: The course of the procedure so that the needle is always visualized. A sterile 20–22 gauge spinal needle is firmly inserted perpendicular to the maternal abdomen. After puncturing the maternal abdomen, the operator punctures the uterus, gains access into amniotic cavity by puncturing the amniotic membrane while taking care not to cause membrane tenting, and proceeds to advance the needle into the amniotic cavity. The needle should be guided into

6968-413: The date of closing , but may also apply to sales of other goods. The phrase caveat emptor and its use as a disclaimer of warranties arises from the fact that buyers typically have less information than the seller about the good or service they are purchasing. This quality of the situation is known as ' information asymmetry '. Defects in the good or service may be hidden from the buyer, and only known to

7072-429: The description provided or any other standards reasonably expectable by a buyer in his/her situation) and does not use the goods or take other actions constituting acceptance of them, the buyer may promptly return or refuse to accept ("reject") them and demand that the defect be remedied ("cured"). When goods fitting the same description and expectations are available for sale ( e.g. , when the vendor has other instances of

7176-426: The development of their own gender-determining products. Gender Mentor claimed to have been used in 20,000 pregnancies. On the show, the results of Osborn's test revealed that was going to have another girl. During the same segment of The Today Show , Couric interviewed Dr. Ronald Wapner, head of maternal fetal medicine at NewYork–Presbyterian Hospital , he discussed possible pros and cons of the test. His first concern

7280-609: The first pregnancy of an Rh negative woman. However, in a subsequent pregnancy with an Rh positive fetus, the formed antibodies can cross the placenta and attack the red blood cells of the fetus, a process called Rh isoimmunization that can result in a condition known as Rhesus disease or hemolytic disease of the fetus and newborn . Hemolytic disease of the fetus and newborn can lead to varying degrees of fetal anemia, which can potentially have devastating consequences including newborn jaundice , kernicterus , hydrops fetalis , and intrauterine fetal demise . RhD immune globulin (RhoGam)

7384-522: The heart, liver, lungs, kidneys, and cerebral tissue. The first amniotic stem cells bank in the US is active in Boston, Massachusetts. There are no absolute contraindications to amniocentesis. Relative contraindications to the procedure include failure to discontinue anticoagulation therapy 48–72 hours prior to amniocentesis, infections such as hepatitis B, hepatitis C , or human immunodeficiency virus (HIV) , and oligohydramnios. These patients are at

7488-498: The initial 24 hours after the procedure, though data supporting this recommendation is limited. Follow-up one week after the procedure is recommended to undergo ultrasound evaluation for fetal viability and assess healing of the puncture site. Post-procedural pain and discomfort should be minimal and temporary and may be managed with acetaminophen . Patients will be instructed to report to an emergency room if they experience vaginal bleeding or leakage of fluid, intense uterine pain, or

7592-403: The lab results given by the Baby Gender Mentor had never been wrong. The Gender Mentor Test used qPCR technology to determine the gender of the baby. It was the first product of its kind to enter the market, despite the fact that many companies had been attempting to develop similar technologies for years. This caused frustration among competitors who had invested significant time and resources into

7696-418: The labs correctly spotted Down syndrome babies 74% of the time. In at least one case, Chang Wang, the president of Acu-Gen, has phoned a pregnant woman one month after giving her the sex prediction to inform her that her test indicated an "excess of genetic material in her blood" and advised her to see her doctor in order "to rule out problems like Down's syndrome or Trisomy 18". Wang explains this means "with

7800-454: The majority of genetic disorders, with amniocentesis being the gold-standard procedure after 15 weeks' gestation. In this procedure, a thin needle is inserted into the abdomen of the pregnant woman. The needle punctures the amnion, which is the membrane that surrounds the developing fetus. The fluid within the amnion is called amniotic fluid , and because this fluid surrounds the developing fetus, it contains fetal cells. The amniotic fluid

7904-582: The majority of genetic disorders, with amniocentesis being the gold-standard procedure after 15 weeks' gestation. Transabdominal chorionic villus sampling is an alternative to amniocentesis if genetic diagnostic testing is to be performed in the first trimester between 10 and 15 weeks' gestation. It is important to note that prenatal genetic testing cannot identify all possible fetal genetic abnormalities or their outcomes. When deciding on whether to perform invasive genetic diagnostic testing such as amniocentesis, patients and their physicians should participate in

8008-447: The management of isoimmunized pregnancies. Amniocentesis is an invasive prenatal test that has the potential to cause maternal and fetal blood cell mixing, which can worsen Rh isoimmunization. Polyhydramnios is an excessive accumulation of amniotic fluid that can lead to serious perinatal and maternal outcomes such as intrauterine fetal demise, preterm labor, premature rupture of membranes, and cesarean delivery. Physicians have used

8112-534: The market." Carson at that time was at the Baylor College of Medicine . Dr. Charles Lockwood , chairman of obstetrics and gynecology at Yale School of Medicine , said that it is possible for fetal DNA to be found in maternal blood as soon as the placenta has developed, and that detection after five weeks "is not impossible" and the president of Acu-Gen said the suit was "totally bogus". There are multiple legal challenges and investigations underway. Gail O'Conner,

8216-486: The maternal circulation, is an extremely rare and catastrophic complication of amniocentesis. Amniotic fluid embolism can result in cardiovascular collapse and has a poor maternal prognosis. However, amniotic fluid embolism following amniocentesis has been reported infrequently in the literature in the last 60 years, mostly in the context of case-reports. Chorioamnionitis and uterine and maternal skin infections are potential complications of amniocentesis that can occur as

8320-424: The money-back guarantee. The attorney Barry Gainey, of Gainey & McKenna, says that Chang Wang, Acu-Gen's President, is "making people send in the original birth certificate . He's making them get blood tests from the newborn baby . And there's other requirements that he's now adding to the refund in order to avoid paying back these people and giving them the 200-percent refund." None of those requirements were on

8424-417: The onset of the amniocentesis, the pregnant patient will undergo ultrasound evaluation to assess fetal viability and position, gestational age, amniotic fluid volume, maximum vertical pocket, umbilical cord insertion site, and any obvious fetal deformities. This information is utilized to determine the needle used and how the procedure should be performed. The fetus should be at least 15 weeks' gestation and

8528-455: The placement of a local anesthetic prior to amniocentesis. Maternal blood type is assessed prior to undergoing amniocentesis and RhD immune globulin (RhoGam) is typically administered within 72 hours of the procedure to prevent maternal isoimmunization in RhD negative patients that are non-sensitized to RhD antigens. Amniocentesis technique differs in twin pregnancies and requires additional operator training. The two different approaches are

8632-408: The present time we need to be concerned whether the test is accurate or not", and "I think it's caveat emptor . Let the buyer beware." Another criticism has come from Sandra Carson, professor of obstetrics and gynecology and involved in research in sex selection. Carson says, "Until Acu-Gen releases its data, there's no way to know the test's reliability. Until that's out, I think it shouldn't be on

8736-484: The procedure with only one puncture attempt. Multiple needle insertion attempts are associated with an increased risk of pregnancy loss. Early amniocentesis, defined as performing the procedure between 10 and 13 weeks' gestation, is associated with significantly higher rates of pregnancy loss following amniocentesis. Early amniocentesis also has higher rates of other complications, including membrane rupture, clubfoot , and amniotic fluid culture failure. For these reasons,

8840-513: The process of inserting a needle transabdominal into the uterus to extract amniotic fluid for the management of hydramnios , or excess amniotic fluid, as early as the late 1800s. Amniocentesis may be performed for both diagnostic and therapeutic reasons. The American College of Obstetricians and Gynecologists recommends that all women be offered prenatal assessment for aneuploidy by either genetic screening or diagnostic testing independent of maternal age or risk factors. Prenatal genetic screening

8944-419: The process of inserting a needle transabdominally into the uterus to extract excess amniotic fluid, also known as a reductive amniocentesis or decompression, for the management of polyhydramnios as early as the late 1800s. Reductive amniocentesis is currently indicated for severe cases of polyhydramnios only. Twin oligohydramnios-polyhydramnios sequence is a rare condition that may occur when twins sharing

9048-406: The purchase price of the test. The new warranty states: We guarantee that all test results are 99.9% accurate. If your test results are legitimately incorrect, Baby Gender Mentor will refund you all costs that include laboratory and purchasing expenses.* A valid registration code and a birth certificate are required for the refund. You MUST read and follow all kit instructions. Baby Gender Mentor

9152-471: The ratio varies in different parts of India, with the greatest imbalance occurring in the most affluent areas. In a certain portion of New Delhi , only 762 girls were born per 1,000 boys. Punjab's Health Minister Ramesh Chander Dogra has said he will take action to ban the test in India. The website for the PregnancyStore.com says that they will ship the tests only within the United States, Sheila McLean , professor of medical ethics at Glasgow University ,

9256-408: The region of the maximum vertical pocket, where the single largest area of amniotic fluid devoid of fetal parts, umbilical cord, and placenta is available for sampling. Amniotic fluid is composed of fetal cells, urine, and lung secretions. 18-20 mL of amniotic fluid is slowly aspirated, with the first 1-2 mL typically discarded due to higher risk of maternal cell contamination. The remaining sample

9360-505: The risk of infant respiratory distress syndrome . Fetal lung development can be tested by sampling the amount of surfactant in the amniotic fluid obtained via amniocentesis. Several tests are available, including the lecithin-sphingomyelin ratio (" L/S ratio "), the presence of phosphatidylglycerol (PG), and the surfactant/albumin (S/A) ratio . An L/S ratio of 2.0 is associated with a lower incidence of infant respiratory distress syndrome. The efficacy of performing amniocentesis for

9464-726: The risk of pregnancy loss following amniocentesis include: Undergoing amniocentesis in the third trimester has been associated with an increased risk of preterm labor, as defined as the onset of labor between 20 and 37 weeks' gestation, and preterm delivery. Preterm premature rupture of membranes (PPROM) and subsequent leakage of amniotic fluid are additional possible complications, with the procedure-related PPROM rate following amniocentesis estimated to be between 1–2%. When compared to cases of spontaneous PPROM, patients with amniocentesis-related PPROM experience better outcomes and lower rates of pregnancy loss. Leakage of amniotic fluid can result in oligohydramnios, or an amniotic fluid volume that

9568-399: The same mass-produced merchandise in stock inventory), either the vendor or the buyer may insist on an "even exchange" for other, "conforming" instances of the product. When conforming goods are not available in stock but are available for the dealer to purchase (usually on the open or "spot" market), the buyer may require that the seller obtain the goods elsewhere, even at a higher price, with

9672-402: The same prediction. The concern is that learning the sex at such an early point may lead parents to terminate the pregnancy if they were hoping for a baby of the opposite sex to that indicated by the test. Americans United for Life argues that women disappointed by the result of their test would find it easier to have an abortion if they get the results early. They say that women who want to have

9776-423: The seller having to incur a loss equivalent to the price difference. If the vendor still does not or cannot provide the goods and the dispute proceeds to litigation (as opposed to renegotiation or settlement), then as in all cases of vendor breaches of contract, the buyer may recover only the damages that s/he would have suffered had s/he taken all feasible steps to minimize ("mitigate") his/her damages suffered. As

9880-465: The seller. It is a short form of Caveat emptor, quia ignorare non debuit quod jus alienum emit ("Let a purchaser beware, for he ought not to be ignorant of the nature of the property which he is buying from another party.") I.e. the buyer should assure himself that the product is good and that the seller had the right to sell it, as opposed to receiving stolen property. A common way that information asymmetry between seller and buyer has been addressed

9984-417: The sex of the baby. In their defense, Acu-Gen stated that ultrasound prediction of the sex of a fetus is not always accurate, and told one family their baby had gender abnormalities. Women were instructed to prick their finger to draw a small amount of blood, which was placed on a card to be sent to Acu-Gen to be analyzed for US$ 250. The kit did not require regulation since it did not diagnose, prevent or treat

10088-675: The single-needle technique and two-needle insertion technique. If used for prenatal genetic diagnosis , fetal cells may be separated by centrifugation from the extracted sample and grown in a culture medium in order to perform genetic tests. The types of tests performed on the sample will be determined by the patient's indications for undergoing amniocentesis. Fluorescent in-situ hybridization (FISH) and quantitative fluorescence polymerase chain reaction (QF-PCR) are two tests commonly performed on uncultured cells after amniocentesis, with results available within two days. These tests can accurately identify trisomy 13, trisomy 18, and trisomy 21. FISH

10192-409: The skin, damage to surrounding internal organs, procedural pain including stinging, pressure, and cramping, and post-procedure discomfort. A serious risk of amniocentesis is pregnancy loss. The American College of Obstetricians and Gynecologists note that the pregnancy loss rates attributable to amniocentesis are very low. The mechanism for pregnancy loss following amniocentesis is unknown but may be

10296-475: The test, which means there should be no risk of harm to the fetus. The test was listed as one of the top 10 innovations of 2005 by research company Datamonitor . In their report, titled Build A Better Mousetrap , Datamonitor identifies their picks for "the best new food, drink, health, household and pet products of 2005". They listed the test as the number 8 innovation of the year. At least 40 women came forward to say their Baby Gender Mentor tests predicted

10400-469: The two companies have common ownership, but no one was available to comment for the NPR story. Acu-Gen does not mention a direct link to BioTronics in their marketing materials. However, they do state on their website that they utilize BioTronics' AmpliSensor technology, according to the Baby Gender Mentor website. AmpliSensor is a quantitative PCR assay invented by Wang and marketed by BioTronics, according to

10504-421: The wrong sex. Compared to the 20,000 women the Baby Gender Mentor test was used on successfully, these 40+ “inaccurate” tests only account for 0.2% of the tests performed. According to a National Public Radio (NPR) report, the company has explained certain inaccurate results as being the result of a vanishing twin , a fetus that stopped growing soon after fertilization. Acu-Gen claimed that their kit could predict

10608-434: Was declared dead and cancelled. At that time, BioTronics' address was listed as "44 Stedman Street, Unit 5, Lowell, MA". Amniocentesis Amniocentesis is a medical procedure used primarily in the prenatal diagnosis of genetic conditions. It has other uses such as in the assessment of infection and fetal lung maturity. Prenatal diagnostic testing, which includes amniocentesis, is necessary to conclusively diagnose

10712-700: Was in error. In this case, the woman delivered a healthy baby free from both Trisomy 18 and Down syndrome. The class action lawsuit filed by Gainey & McKenna alleges that Acu-Gen is improperly dispensing medical advice. The law firm claims Wang has contacted "many women" and advised them that their fetuses have chromosomal abnormalities. They claim that Dr. Wang, who is listed as a Ph.D., is providing women "with all sorts of medical advice and diagnoses". They say their clients have suffered great emotional distress and have undergone unnecessary medical testing based upon Dr. Wang's "advice". Acu-Gen has allegedly created new requirements for people who want to take advantage of

10816-406: Was whether the stated accuracy rate achieved in the 2,000 test cases would be realized in real world usage. His second concern was whether couples who purchase the test might use the results for family balancing , which means the decision to utilize selective abortion to achieve a baby of the desired sex. Wapner said that one positive aspect of the Baby Gender Mentor test is the non-invasive nature of

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